QUALITY ASSOCIATE SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Published: Dec 02, 2025 - The Quality Associate has a strong background in cGMP-regulated industries, with hands-on experience in pharmaceutical or medical device manufacturing and laboratory operations such as chemistry or microbiology. This role requires proficiency in computer-based systems, including LIMS, excellent analytical and problem-solving skills, and the ability to manage multiple tasks with strong organizational and project management capabilities. The associate also demonstrates effective communication and interpersonal skills, applies lean principles, and actively contributes to process improvement initiatives across global teams.

Essential Hard and Soft Skills for a Standout Quality Associate Resume
  • Document Management
  • Quality Auditing
  • Data Analysis
  • Material Testing
  • Sampling Management
  • Change Control
  • CAPA Execution
  • QMS Documentation
  • Regulatory Compliance
  • Root Cause Analysis
  • Process Improvement
  • Problem Solving
  • Team Communication
  • Cross Functional Collaboration
  • Training Coaching
  • Quality Issue Escalation
  • Department Leadership
  • Customer Communication
  • Committee Participation
  • Work Instruction Compliance

Summary of Quality Associate Knowledge and Qualifications on Resume

1. BS in Quality Assurance with 3 years of Experience

  • Experience in the quality department, preferably in retail/FMCG or e-commerce.
  • Track record of achievement with a ‘get up and go’ spirit.
  • Able to demonstrate enthusiasm and an entrepreneurial mindset.
  • Able to take ownership of responsibilities and show a real drive to get things done at pace.
  • FMCG or retail experience.
  • Excellent communication and problem-solving skills, with a natural ability to work with data.
  • Able to collaborative working culture and commitment to the team.
  • Must have energy and a sharp mind, collaborative and can-do approaches.
  • Able to analyze and be consumer-focused.

2. BS in Mechanical Engineering with 4 years of Experience

  • Quality experience in a Medical Devices manufacturing or startup environment.
  • Working knowledge of standards such as ISO 13485, 21 CFR 820, Therapeutic Goods (Medical Devices) Regulations and other applicable standards.
  • English with strong written and oral communication skills.
  • Working knowledge of Continuous Improvement Tools and Process validation experience.
  • Must have computer-literate use of statistical programs.
  • Must have considerable foresight and planning abilities in order to achieve the required objectives.
  • Able to perform analytical and strategic processes.
  • Must have team-oriented skills for problem resolution and implementation of projects.
  • Problem-solving, logical person.

3. BA in Business Administration with 5 years of Experience

  • Experience in software Testing/Quality Assurance/Automation/especially in white box and functional testing.
  • Proficient in Manual and Automated Testing, hands-on experience in automation, esp Selenium.
  • Experience working in a development team as a quality engineer.
  • Experience in QA processes and tools, test management systems, designing and running tests on web applications or backend systems and analyzing bugs.
  • Functional knowledge of at least one SAP module to help the team perform the functional correctness testing.
  • Experience in being part of large-scale software development projects distributed across geographical locations.
  • Experience working within an Agile/Scrum development environment.
  • Strong communication and creative problem-solving skills.
  • Ability to work effectively in a fast-paced and changing business environment.

4. BS in Industrial Engineering with 4 years of Experience

  • Experience in QA function w/in a biotech/pharmaceutical company or other regulated industries.
  • Strong knowledge of manufacturing processes and the impact of deviations on the quality of the product.
  • Through understanding of cGMP, regulatory requirements, SOPs, and CAPA management.
  • Must have change control systems knowledge (MasterControl).
  • Able to familiarize with the SAP or similar system.
  • Must have fabulous communication skills and attention to detail.

5. BS in Computer Science with 2 years of Experience

  • Ability to identify operational opportunities for improvement.
  • Excellent communication and interpersonal skills with all levels of employees and management.
  • Strong organizational and administrative skills.
  • Ability to operate within a team environment, multitasking and prioritizing work across supported clients.
  • Able to use appropriate mannerisms and behavior when interacting with client groups and or all levels of employees and management.
  • Able to communicate comfortably with Accenture management or client points of contact.
  • Able to escalate conflicts in a timely manner to the appropriate personnel.

6. BA in Organizational Leadership with 4 years of Experience

  • Experience in the managed care field.
  • Knowledge and experience in quality assurance/improvement, data collection, statistical analysis and preparation of reports.
  • Proficient in the Microsoft suite, including Excel, PowerPoint, Word, and Outlook.
  • Ability to act as an advocate for the frail elderly with all groups served in the program.
  • Ability to be flexible, creative and the ability to work with an ethnically diverse group of participants and employees.

7. BS in Applied Statistics with 7 years of Experience

  • Experience in Quality Management in the healthcare sector to ISO 9001 and ISO 13485.
  • Must have tertiary qualifications with experience in a regulated clinical medical device.
  • Proven collaboration experience across multiple internal and external departments, including Clinical, R&D, Supply Chain, Manufacturing, Senior Management and external Quality Consultants.
  • Must have hosting ISO 13485 audits and conducting internal and supplier audits.
  • Able to perform post-market activities, including product recalls, complaint handling, and adverse event reporting.
  • Able to write device specifications, undertake inbound inspections, and final product releases.
  • Able to work with functional experts to provide timely responses to questions from the manufacturers.
  • Experience in Lean Six Sigma.
  • Must have engineering qualifications.
  • Able to gain exposure to the clinical sectors of orthopaedics, neurosciences and/or spine-related medical devices.
  • Must have natural talent to influence and build relationships across an organisation to achieve success.

8. BA in Supply Chain Management with 4 years of Experience

  • Sound knowledge of Software QA principles and practices.
  • Proficient with at least one of the following programming languages: C++/C, Java, Python, and Shell-Scripting.
  • Hands-on experience in Unix (user level and shell scripting) and SQL.
  • Experience with using and administering a DBMS (Sybase/Oracle/DB2).
  • Demonstrated proficiency in one or more areas, viz., test development, test automation, code coverage and performance testing.
  • Experience with continuous integration/continuous delivery concepts and tools, e.g., Git, Gerrit.
  • Strong problem-solving and analytical ability.
  • Able to demonstrate verbal and written working proficiency in English.
  • Must have M.Tech (Computer Science) experience.

9. BS in Food Science with 5 years of Experience

  • Practical exposure to quality systems (sampling, testing, reviewing, approving).
  • Experience in manufacturing in a cGMP environment.
  • Proficient in Microsoft Excel and Word.
  • Excellent organization and time management skills.
  • Must be able to communicate issues, troubleshooting actions, and resolution options effectively, with strong grammar and proofreading/editing skills.
  • Must be able to stand for extended periods of time, squat, grasp, and lift containers in excess of 20 lbs.
  • Demonstrated ability to perform basic math functions.
  • Able to independently solve problems and make decisions based on company and/or quality policy.
  • Demonstrated ability to improve and refine processes.
  • Able to exposure with continuous process improvement tools like green belt, 5S, Kaizen, Lean 6 sigma.
  • Demonstrated problem-solving skills.
  • Ability to both work in teams and independently and make objective decisions.
  • Must be quality-oriented and possess the ability to consistently maintain an exceptional level of attention to detail.
  • Able to rapidly adapt to changing environments and circumstances requiring flexibility, tolerance and a great sense of urgency while ensuring that cGMP and regulatory requirements are met.
  • Able to perform quality assurance, GMP, SOP, CAPA, FDA, documentation control, batch record, batch review, inspection, visual inspection, documentation, quality, qa, CGMP, quality check, safety, data entry, audit, regulatory, batch record review.

10. BA in Organizational Leadership with 4 years of Experience

  • Experience in the Quality function within a biotech or pharmaceutical company or other similarly regulated industry.
  • Strong demonstrated knowledge of FDA regulations, specifically the application of (GMP) Good Manufacturing Practices.
  • Strong knowledge of manufacturing processes and the impact of deviations on the quality of the product.
  • Able to change control.
  • Must have computer competence utilizing industry standard Quality systems (Master Control, SAP).
  • Must have advanced Excel skills.
  • Strong interpersonal skills and great attention to detail.
  • Must be a strong team player with good problem-solving, good verbal and written communication skills, and the ability to handle multiple, rapidly changing priorities.
  • Good communication skills, written and verbal.
  • Good with Microsoft Office, Outlook, Word, and Excel.

11. BA in Human Resources Management with 3 years of Experience

  • Experience in a medical device, pharmaceutical, clinical, or healthcare environment.
  • Excellent proficiency in English, ability to proofread and edit technical documentation.
  • Must have a Quality Assurance background in a regulated industry.
  • Knowledge and understanding of ISO 13485.
  • Strong working knowledge of MS Office, especially Word and Excel.
  • Able to pay attention to detail, write and do mathematics.

12. BA in Operations Management with 6 years of Experience

  • Industrial experience in the Pharmaceutical or Healthcare industry.
  • Proven comprehensive knowledge of Quality of Design (QbD), Process Understanding Control and Capability (PUCC) and associated tools and has demonstrated understanding of these tools as well as a comprehensive knowledge of relevant processing technology and equipment, including Process Analytical Technologies (PAT).
  • Proven knowledge and demonstrated understanding of process validation principles and implementation of process validation protocols.
  • Good mathematical ability, statistics and design of experiments (DoE) experience and data analysis.
  • Must have project management skills and proven ability to handle multiple priorities in an ever-changing business environment.

13. BS in Manufacturing Engineering with 4 years of Experience

  • Understanding of regulations in relation to Distribution, European Pharmaceutical Directive related to Distribution of Medicinal Products, as well as Good Distribution Practice (GDP), Good Manufacturing Practices (GMP), Falsified Medicines Directive and Medical Device Regulations.
  • Knowledge of the role of EMA and country health authorities.
  • Strong word processing, database and spreadsheet application skills.
  • Fluent in English and Dutch, and French.
  • Must have problem-solving skills.

14. BS in Biotechnology with 2 years of Experience

  • Must be able to perform all physical demands of the position, including bending, stooping, reaching, walking, and lifting up to 50 lbs., on a limited basis.
  • Must be able to read and comprehend simple instructions, written correspondence, and memos, and have the ability to write simple correspondence.
  • Must be able to perform basic math skills to include addition, subtraction, multiplication, and division.
  • Must demonstrate ability to communicate effectively, both written and verbal.
  • Must demonstrate ability to work well with other departments.
  • Must demonstrate excellent analytical and organizational skills.
  • Able to use various instruments and equipment (i.e., calipers, micrometers, hardness gauge, forklift, pallet jack, etc)
  • Basic computer experience using MS Office, Word, Excel, WMS, etc.

15. BS in Mechanical Engineering with 1 year of Experience

  • Prior QC, Warehouse, or Manufacturing experience.
  • Experience with Microsoft Office programs such as Word, Excel and Outlook.
  • Able to lift 40 pounds unassisted.
  • Able to reach, bend, kneel and climb while performing repetitive tasks.
  • Ability to work in hot and cold environments.
  • Able to correctly wear PPE for entire shifts.
  • Able to react and respond quickly to noises, smells, visual hazards, and alerts.

16. BS in Industrial Engineering with 2 years of Experience

  • Experience working in a lab environment.
  • Must have SPC knowledge.
  • Good communication and organizational skills.
  • Able to safety-conscious team player who works with minimal supervision.
  • Strong initiative and accepts responsibility for the validity of lab results, test records, and calibration checks.

17. BS in Chemical Engineering with 4 years of Experience

  • Experience in ISO9001, ISO13485, TGA and FDA regulatory framework.
  • Experience working with class I or class II medical devices.
  • Must have Certificate IV in Engineering or equivalent qualification.
  • Proven experience and knowledge of writing and controlling documents.
  • Proven experience in NCR and CAPA systems.
  • Able to apply practical and pragmatic problem-solving.

18. BA in Organizational Leadership with 2 years of Experience

  • Must have NCR experience.
  • Excellent verbal and written communication skills.
  • Excellent interpersonal and customer service skills.
  • Exceptional attention to detail.
  • Ability to work in a team environment.
  • Ability to multitask and complete work independently.
  • Must have intermediate computer skills to including Proficiency in Microsoft Office.

19. BS in Environmental Science with 3 years of Experience

  • Experience in the Greenhouse industry.
  • Able to pay attention to detail and the ability to communicate ways to improve business practices.
  • Proficient in the use of computers and Microsoft applications such as Word, Outlook, and Excel.
  • Experience in documenting and implementing SOPs.
  • Must have a quality background.

20. BS in Applied Statistics with 4 years of Experience

  • Experience in a food and beverage or pharmaceutical multinational organization’s quality department.
  • Strong experience in Laboratory Operation.
  • Good understanding of Laboratory Operation and Manufacturing process in Beverages, FMCG, or Pharmaceutical industries.
  • Good knowledge of laboratory information management systems, SAP functionalities, including the quality module.
  • Experience in lean/flat reporting line, but with intense workloads and high complexity of tasks.
  • Ability to organise and prioritise work to meet deadlines in a dynamic environment.

21. BS in Computer Science with 2 years of Experience

  • Must have manufacturing experience.
  • Must have above-average mathematical skills, written skills, and verbal skills.
  • Ability to interpret blueprints, drawings, schematics, etc.
  • Must be computer-literate.
  • Ability to demonstrate overall professionalism in a business environment.
  • Ability to use basic measurement devices such as micrometers, calipers, indicators and etc.
  • Must have the ability to judge color visually and must pass the Farnsworth-Muncell 100 Hue test yearly and the pastes test with a minimum score of 50.

22. BA in Supply Chain Management with 4 years of Experience

  • Knowledge of GMP and GDP and MHRA Guidance Note 14.
  • Practical experience in GxP Supply Chain, Production and Quality Assurance.
  • Pro-active and solutions-driven, with the ability to work to strict deadlines with a high level of accuracy.
  • Excellent communication skills, verbal and written.
  • Ability to communicate effectively at all levels of the business.
  • Must have IT literacy, Microsoft Outlook, Word, and Excel.
  • Highly self-motivated with strong interpersonal skills.
  • Effective planning and time management, organisational and administrative skills.
  • Ability to work with cross-functional teams on new process projects, incident investigation, identification of root causes and process improvements.
  • Able to remain adaptable to the business requirements.
  • Able to work under pressure and act logically where urgent scenarios arise.
  • Knowledge of warehousing and logistics processes in a GDP environment.

23. BS in Mechanical Engineering with 8 years of Experience

  • Must have endorsement on wide-body aircraft.
  • Must have experience with aircraft documentation in maintenance and modification.
  • Must have experience with maintenance ERP.
  • Understanding of the CC150 airworthiness program following the completion of the MPM/MCD training.
  • Knowledge of CARs and TAM for the role.
  • Sound knowledge of maintenance, tooling and material support program.
  • Sound knowledge of applicable processes, forms and instructions related to the PRAA area of responsibility.
  • Understanding of SMS and FS programs through the completion of the SMS and FS training.
  • Practical knowledge of the job area is typically obtained through advanced education combined with experience.
  • Strong technical understanding of occupational health, safety and environmental regulations and practices.
  • Excellent communication skills in English (written, verbal, presentation).
  • Proficient in computer and technical application skills.
  • Must be eligible for registration in the Controlled Goods Program.

24. BA in Operations Management with 6 years of Experience

  • Related quality engineering/validation experience.
  • Must have American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification.
  • Must have computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include JDE, BPLM, TcU, Trackwise, etc.)
  • Able to display a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise.
  • Experience in manufacturing/quality Engineering in an FDA-regulated environment, knowledge and working application of FDA cGMP, ANSI/ISO/ASQC, and CMDAS requirements.
  • Must have computer competency in PowerPoint, Minitab, Access, and databases.
  • Practical experience in manufacturing, test equipment, inspection and Statistical analysis techniques.
  • Experience in the medical device industry development and deployment of Quality systems, Process Controls and Continuous Improvement Methods (QSR, ISO13485).
  • Must have CQE, CSSBB, CQA, or the initiative to complete certifications.
  • Ability to multitask and methodically manage projects.
  • Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
  • Ability to effectively operate in and facilitate cross-functional teams with guidance.
  • Must be able to provide solutions that reflect CT's understanding of business objectives and cost implications.

25. BS in Manufacturing Engineering with 3 years of Experience

  • Able to coordinate (including yard activity) of supplier spills.
  • Able to learn to help coordinate containment/sort/re-work.
  • Able to learn to provide on-site/local sorting and testing (dimensional/material/functional).
  • Able to learn to develop and communicate inspection standardized work/methods.
  • Able to learn to understand and verify receipt of break point material, record vehicle or material breakpoints and make sure that all old stock is quarantined.
  • Able to respond to requests for support 24/7.
  • Able to support controlled shipping activities.
  • Basic ability to assist in problem-solving teams (PRTS, GCA, 24 hr, Warranty, JD Power, etc.)
  • Knowledge of PC software applications, including Word, Excel, and Company Software.
  • Must demonstrate automotive industry knowledge.
  • Must demonstrate Quality Control knowledge.

26. BS in Industrial Engineering with 1 year of Experience

  • Must have Lowe’s Appliance Handling Standards.
  • Must have Lowe’s Carton Damage Standards.
  • Must have basic math calculations.
  • General knowledge of computers.
  • Previous quality assurance role.
  • Able to read and interpret specifications and drawings.
  • Able to use standard measuring equipment.
  • Able to be self-motivated.
  • Able to maintain a neat/organized work area and documentation.
  • Strong attention to detail.

27. BA in Business Administration with 2 years of Experience

  • Related experience working in a corporate environment (minimum 1 year).
  • Professional attitude and appearance.
  • Exceptional telephone etiquette and communication skills (written and verbal).
  • Advanced knowledge of Microsoft Office (Excel, PowerPoint, and Word).
  • Must have a strong work ethic and be customer-focused.
  • Must be willing to take ownership of decisions and responsibility for outcomes.
  • Must have impeccable attention to detail and accuracy.
  • Must have suitable spoken and written communication skills, with the ability to present information effectively, using appropriate methods, in one-on-one and small group situations to customers, vendors, and other employees, and must be able to draft professional communications.
  • Must be able to prioritize and multitask effectively, and be able to perform well in a high-pressure, demanding environment.
  • Understanding of QA principles and concepts of ISO 9001:2015 (or similar QMS).
  • Highly organized with strong attention to detail and accuracy.

28. BS in Quality Assurance with 3 years of Experience

  • Able to conduct process reviews (QC) against work instruction and quality specification sheets and determine if the operation and product being evaluated are compliant.
  • Able to inspect a selection of finished products (QA) against customer expectations and NB Global Standards.
  • Able to assist manufacturing in problem-solving quality issues by identifying root cause, trialing, and implementing countermeasures.
  • Able to develop interim containment plans.
  • Able to design and create spreadsheets to gather and analyze inspection data for use within the facility and/or as part of the SMR process.
  • Able to work with supervisors and other quality-related associates to resolve issues as identified by the inspections and to continuously improve methods used.
  • Able to perform daily tasks, including data entry, track returned finished goods movement through the facility, and assist others in understanding quality issues.
  • Understanding and working knowledge of quality tools and problem-solving methodology.
  • Ability to recognize and problem-solve root causes of defective products.
  • Excellent communication skills.
  • Must have computer skills, including Office (Word, Excel).

29. BA in Organizational Leadership with 4 years of Experience

  • Quality experience in a pharmaceutical manufacturing environment.
  • Thorough knowledge and ability to apply Health Canada cGMP regulations.
  • Excellent communication and interpersonal skills.
  • Demonstrated skills in successful collaboration.
  • Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, and Documentum platforms.
  • Must be highly motivated, organized and able to work effectively and efficiently in a demanding environment with the flexibility to change priorities.
  • Able to take initiative and is proactive, persistent.

30. BS in Manufacturing Engineering with 1 year of Experience

  • Good written and oral communication skills.
  • Basic computer knowledge.
  • Ability to use a calculator to perform basic math functions and understand the concept of same, including add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals, compute ratios, rates and percentages.
  • Ability to carefully monitor activities using instruments, gauges and processes.
  • Working knowledge of current Good Manufacturing Practices.

31. BS in Computer Science with 5 years of Experience

  • Experience in a Pharmaceutical Manufacturing, QA, or QC Assurance role.
  • QA experience performing batch review and release activities of suppliers or contract manufacturers, or equivalent, supporting commercial products and/or development projects.
  • Knowledge of the GMP requirements for batch review and release of Commercial Product and/or Drug Development API or Bulk Drug Product.
  • Knowledge of FDA 21 CFR 211 and 210.
  • Experience with TrackWise System for handling deviations, change controls, complaints, CAPA, investigations, etc.
  • Microsoft Office Suite proficient (Word, Excel, PowerPoint, Outlook).
  • Solid analytical and problem-solving skills.
  • Great interpersonal skills.
  • Excellent communication skills (written and verbal).
  • Strong attention to detail.
  • Must be highly organized.
  • Experience performing batch review and release activities of suppliers or contract manufacturers, or equivalent.

32. BS in Environmental Science with 3 years of Experience

  • Related experience in quality control testing or electrical.
  • Ability to read schematics, nameplates, electrical drawings, and measurement instruments such as oscilloscopes, power analyzers, and voltmeters.
  • Solid knowledge of basic electrical theory.
  • Must be computer literate.
  • Proficient in Excel.
  • Basic electrical troubleshooting skills.
  • Strong math background.
  • Ability to speak effectively, write routine reports and correspondence.
  • Ability to understand test procedures and requirements and explain them to customers.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Must be articulate and professional, with good interpersonal skills, because of frequent customer witness tests in the test lab.

33. BA in Operations Management with 6 years of Experience

  • Experience in IT platform implementation in a technical and analytical role.
  • Experience with Data Lake/Hadoop platform implementation.
  • Hands-on experience in the implementation and performance tuning of Hadoop/Spark implementations.
  • Experience Apache Hadoop and the Hadoop ecosystem.
  • Experience with one or more relevant tools (Sqoop, Flume, Kafka, Oozie, Hue, Zookeeper, HCatalog, Solr, Avro).
  • Experience with one or more SQL-on-Hadoop technologies (Hive, Impala, Spark SQL, Presto).
  • Experience developing software code in one or more programming languages (Java, Python, etc.)

34. BA in Business Administration with 5 years of Experience

  • Knowledge of cGMP and applicable FDA regulations.
  • Experience in a cGMP/FDA-regulated environment.
  • Experience reviewing GMP documentation, including protocols, reports, batch records and data.
  • Must be able to organize information in a consistent and retrievable manner.
  • Able to detail-oriented team player with effective planning, organization, and execution skills.
  • Excellent communication skills with internal and external personnel.
  • Experience with electronic documentation management systems (EDMS).
  • Strong computer skills with Word and Excel.
  • Ability to work effectively at a fast pace with cross-functional departments.
  • Ability to innovate, proactive, and resourceful, committed to quality and continuous improvement.
  • Ability to anticipate and mitigate challenges.

35. BS in Quality Assurance with 4 years of Experience

  • Able to perform all types of inspections and monitoring to support all phases of assembly and manufacturing, including purchased material, customer-supplied materials and parts.
  • Thorough knowledge of blueprint readings/interpretation, math, as well as a complete understanding of engineering drawing and specifications.
  • Able to demonstrate knowledge of how to use basic measuring equipment and instruments to continuity check various assemblies/details parts, including basic personal computing literacy.
  • Understanding of basic workmanship acceptance criteria used on the production floor.
  • Able to familiarize with all paperwork/documentation associated with the aforementioned inspection functions and be able to properly document in a neat and legible manner, all types of errors or discrepancies found.
  • Must have a thorough knowledge of the correct procedures to follow and precautions to take when performing their work in order to prevent damage to equipment and/or material and injury to self and/or others.

36. BS in Mechanical Engineering with 3 years of Experience

  • Quality/CGMP experience in the pharmaceutical industry.
  • Excellent written/oral communication skills with a strong discipline in Microsoft Programs.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
  • Ability to work autonomously within established guidelines, procedures, and practices.
  • Able to commit to delivering high-quality results, overcoming challenges, and focusing on what matters.
  • Able to continuously look for opportunities to learn, build skills, and share learning.
  • Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances.

37. BS in Chemical Engineering with 4 years of Experience

  • Quality department experience within the pharmaceutical/biotech/medical device sector.
  • Knowledge of GLP, GMP, or ISO 13485 regulations and compliance in one or more of the following regulatory frameworks: TGA, FDA, MHRA, EMA.
  • Knowledge and experience in any of the following: validation of process, equipment, facility, computer systems, cleaning, utilities, or analytical test methods, bioanalytical assay method development and validation, validation and verification, aseptic or biologics manufacturing.
  • Demonstrated problem-solving and critical thinking skills, task-oriented with a solutions-focused approach.
  • Must have a high level of drive, enthusiasm and a ‘can-do’ approach, comfortable working in a fast-paced, rapidly changing environment.
  • Willingness to learn and to seek answers to problems and issues and propose solutions.
  • Able to collaborate and participate team, communication and relationship skills.
  • Effectively working with others to ensure the business needs and timelines are met.
  • Must have a high capacity for self-managing, planning, organising, prioritising and multi-tasking, independently and as part of a cross-functional team.
  • Able to manage priorities within prescribed timeframes.
  • Proven interpersonal skills and excellent communication skills (verbal/written/presentation) with the ability to work collaboratively with internal stakeholders and external partners.

38. BS in Food Science with 5 years of Experience

  • General business experience and industry experience.
  • Experience in data collection and reporting.
  • Experience in coaching and development.
  • Proven analytical, problem-solving, and project management skills.
  • Exceptional client focus and strong client relationship management skills.
  • Excellent oral, written, and interpersonal communication skills.
  • Ability to work independently as well as cross-site with all levels within the department.
  • Ability to effectively manage multiple priorities with close attention to detail and accuracy.
  • Must have flexibility, good judgment, and time management skills.
  • Working knowledge of Microsoft Office products.
  • Must have ve statistical background.
  • Must have training experience.
  • Fluent in Spanish.

39. BS in Environmental Science with 2 years of Experience

  • Experience in Testing/Quality Assurance or related role.
  • Ability to multitask.
  • Strong communication skills (both written and verbal).
  • Strong analytical skills.
  • Able to detailed and quality-oriented manner.
  • Able to team player with the ability to work independently.

40. BS in Biotechnology with 5 years of Experience

  • Proficient with computer-based systems and software, including prior LIMS experience.
  • Understanding of laboratory operations (e.g, chemistry or microbiology).
  • Strong analytical and problem-solving skills.
  • Strong knowledge of pharmaceutical/medical device manufacturing and Good Documentation Practices.
  • Ability to effectively communicate across multiple levels with a global audience.
  • Strong organizational skills and ability to prioritize multiple tasks.
  • Good interpersonal/influencing skills.
  • Good project management skills.
  • Able to be detail-oriented.
  • Relevant work experience in cGMP cGMP-related industry and/or pharmaceutical laboratory.
  • Experience in manufacturing laboratory operations.
  • Experience with laboratory information management systems.
  • Experience driving process improvement initiatives and projects.
  • Able to application of lean principles.
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