CHEMICAL ANALYST JOB DESCRIPTION

Pharmaceutical testing never stops. A Chemical Analyst keeps product release moving by generating the HPLC, GC, and spectrophotometric data that QC decisions depend on - every batch, every shift. This role holds direct responsibility for GMP-compliant sample testing, OOS and OOT investigation, and the documentation that survives regulatory inspection. It operates within the Quality function, working alongside QA, production, and regulatory teams across biologics, plasma derivatives, and solid-dose manufacturing. Getting it wrong means product holds, compliance gaps, and failed audits.

As the Chemical Analyst, you execute quantitative and qualitative testing across raw materials, in-process samples, and finished pharmaceutical products, ensuring every result meets cGMP standards and documented specifications before release. You work within the QC laboratory, contributing directly to CAPA resolution, method verification, and audit readiness under the supervision of the QC Manager or Laboratory Lead.

Career Impact: Deep hands-on experience with OOS investigations and regulatory inspection preparation builds the technical credibility that opens doors to method development, validation, and QC leadership roles in regulated pharmaceutical environments.

Business Impact: Every product batch released or held traces back to your results - accurate, timely testing directly determines whether patients receive compliant medicines on schedule.

Growth Opportunity: Proficiency gained across HPLC, GC, and biologics-specific techniques, combined with CAPA and method transfer experience, positions the analyst for advancement into senior QC, validation specialist, or analytical development roles.

• Test raw materials, in-process samples, and finished products using HPLC, GC, spectrophotometry, and related analytical techniques to approved SOPs.
• Investigate Out of Specification and Out of Trend results, identify root cause, and document findings in compliance with cGMP requirements.
• Perform instrument calibration checks and routine maintenance, escalating faults outside self-authority to ensure laboratory readiness at all times.
• Review and prepare QC documentation including batch records, change requests, and logbooks in full compliance with regulatory standards.
• Support method verification, validation, and technical transfer activities in coordination with analytical development and production teams.
• Prepare for and participate in regulatory and internal audits, maintaining the laboratory area in a continuous state of inspection readiness.
• Participate in CAPA processes related to QC findings, contributing to corrective action planning and preventive measure implementation.

• Bachelor's degree in Chemistry, Biochemistry, or a closely related scientific discipline, or equivalent work experience.
• 2 or more years of hands-on QC laboratory experience in a pharmaceutical or regulated life sciences environment, with direct exposure to cGMP standards.
• Proficiency in quantitative analytical techniques including HPLC and GC, with demonstrated ability to operate, troubleshoot, and maintain laboratory instrumentation.
• Working knowledge of GMP, GLP, and applicable regulatory guidelines governing pharmaceutical quality control testing.
• Experience investigating OOS or OOT results and preparing thorough, audit-ready investigation reports.
• Strong technical writing skills with the ability to accurately complete and review batch records, SOPs, and change control documentation.

• Experience with method transfer, verification, or validation projects in a regulated pharmaceutical setting.
• Familiarity with biologics or protein-based therapeutics and associated analytical techniques such as immunoelectrophoresis or flame photometry.
• Experience with statistical analysis software used for quality data review and trend monitoring.
• Knowledge of laboratory information management systems in a GMP-regulated environment.

• OOS investigation closure rate, tracking timely resolution of non-conforming results within defined CAPA timelines.
• First-pass documentation accuracy rate, measuring how often batch records and test reports are completed correctly without correction.
• Instrument uptime percentage, reflecting the analyst's contribution to calibration compliance and routine maintenance scheduling.
• Audit observation count attributable to the QC lab, measuring inspection readiness across documentation, housekeeping, and procedural compliance.
• Method transfer completion against project milestones, tracking on-time delivery of verified analytical procedures.
• Typical tools: Chromatography data systems (commonly Empower or Chromeleon); LIMS platforms (commonly LabWare or Veeva Vault QMS).

• Base Salary Range: $55,000 to $80,000 annually, depending on experience and seniority
• Bonus: Annual performance-based bonus, typically 5 to 10% of base salary
• Equity: Generally not offered at this level in pharmaceutical QC roles
• Health Benefits: Medical, dental, and vision coverage; employer contribution standard
• PTO: 15 to 20 days annually, plus federal holidays and sick leave
• Common Perks: Tuition reimbursement, professional certification support, shift differential for non-standard hours

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Work authorization in the United States is required for this position. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, veteran status, or any other characteristic protected under applicable federal, state, or local law. Reasonable accommodations are available to individuals with disabilities upon request. Employment is contingent on successful completion of a background check and, where applicable, a drug screening consistent with regulatory requirements.

The Chemical Analyst owns the development and deployment of analytical methods, including SEM/EDX, GC-MS, and FTIR, to determine the chemical composition of materials used in semiconductor devices. Working alongside the package analysis team and reporting into the broader semiconductor engineering function, this role directly enables manufacturing to resolve material-related root causes and advance technology development.

Key Responsibilities

• Analyse chemical composition of materials used in semiconductor devices.
• Perform SEM/EDX, IC-MS, GC-MS, AFM/Optical Profiler, and FTIR analysis.
• Coordinate with the package analysis team for sample preparation.
• Participate in problem-solving projects to track down root causes and prevent reoccurrence.
• Lead and support technology development projects, including developing methods to analyse materials used in the semiconductor industry.
• Deploy developed methods into general practice and coach colleagues.

Required Qualifications

• Bachelor's or Master's degree in Analytical Chemistry.
• Experience operating analytical tools and techniques, including SEM/EDX, IC-MS, GC-MS, AFM/Optical Profiler, and FTIR.
• Experience in method development or project leadership is an asset.
• Knowledge of semiconductor fabrication.
• Knowledge of packaging, material, and assembly processes.
• Strong analytical problem-solving skills.
• Effective oral and written communication skills with intercultural awareness.
• Detail-oriented approach with a drive for precision and willingness to take ownership.
• Ability to work under pressure and flexibility to work outside standard office hours.

Embedded within a consulting team focused on chemicals markets, the Chemical Analyst delivers rigorous analysis across feedstocks, value chains, costs, and pricing to support internal and external clients. Working closely with senior consultants and drawing on internal and external data sources, this role builds the analytical and consulting capabilities that enable clients to navigate industry trends including decarbonisation and sustainability.

Core Functions

• Contribute to consulting projects by carrying out analyses on all aspects of chemicals, including feedstocks, manufacturing, product value chains, markets, costs, prices, and margins.
• Conduct chemicals research and data collection using internal and external sources.
• Format and present data and analyses in consulting reports and presentations with informed commentary to support internal and external clients.
• Develop proficiency in core consulting methodologies, analytical techniques, and tools for market supply, demand, and trade forecasts, pricing, and cost competitiveness.
• Follow relevant chemical and wider industry news and trends, including decarbonisation, energy transition, renewables, circularity, and sustainability.

Qualifications & Experience

• A science or engineering degree, with chemistry or chemical engineering preferred.
• 2–5 years of work experience in a related industry.
• Expertise in handling and analysing data in Excel.
• Fluency in English.
• Proficiency in additional European languages is advantageous.
• Excellent writing and communication skills.
• Strong delivery focus and time management skills.

Reporting to laboratory management, the Chemical Analyst shapes daily sample preparation and analytical testing across IC, UV/Vis, titrations, IR Spectroscopy, and carbon analysers to maintain quality compliance. Partnering with the QA function and wider lab team, this role enables the organisation to meet client turnaround times and uphold rigorous data integrity standards.

Primary Duties

• Prepare routine samples for IC, UV/Vis, titrations, IR Spectroscopy, and carbon analysers.
• Maintain instruments and perform data entry, review, and interpretation.
• Conduct QA investigations and instrument and analytical troubleshooting.
• Perform statistical analysis on quality control samples to ensure compliance.
• Follow laboratory policies, procedures, safety requirements, and sample requirements.
• Participate in laboratory skills inventory and ensure turnaround times are achieved.

Skills & Qualifications

• Bachelor's degree in Chemistry or a related science discipline.
• Proficiency in Word and Excel.
• Ability to work independently and in a team environment.
• Ability to troubleshoot issues independently.
• Highly organised with strong attention to detail.
• Flexibility to work evenings and weekends to meet client workload demands.

Sitting at the intersection of quality assurance and laboratory operations, the Chemical Analyst leads the execution of QC and stability testing, including HPLC/GC analysis and routine water testing, on raw materials, in-process, and finished pharmaceutical products. Operating across GMP compliance, out-of-specification investigations, and process improvement initiatives, this role ensures products meet regulatory standards and directly supports the organisation's quality and compliance outcomes.

Duties

• Review compliance of products with GMP, quality standards, and product specifications.
• Optimise and facilitate implementation of current processes.
• Propose changes or improvements to processes, tools, and techniques.
• Prepare and analyse samples according to SOPs.
• Prepare and operate laboratory equipment according to SOPs.
• Perform calibration checks on equipment according to calibration procedures to ensure accurate results.
• Prepare reagents and solutions for testing.
• Perform HPLC/GC analysis using the method of analysis.
• Perform routine stability tests, including related substances, assay, and dissolution, to assess product quality.
• Perform daily and weekly water testing according to SOPs.
• Support testing for out-of-specification investigations to establish systematic issues in process or testing.
• Report feedback on services or outputs regularly.
• Document and store data according to SOPs and regulations.
• Consolidate information for weekly and monthly reports, analyse consolidated data, and provide recommendations.
• Record, interpret, and report testing results to management, including out-of-specification results.

Position Requirements

• National Diploma in Analytical Chemistry.
• Minimum of 2 years of experience.
• Knowledge of Millennium Software (HPLC) and GC software.
• Advanced understanding of pharmaceutical testing methods.
• Understanding of pharmaceutical manufacturing and corrective action programmes.
• Knowledge of pharmaceutical standards and compliance requirements.
• Ability to interpret and implement policies, processes, and objectives.
• Demonstrates initiative, problem-solving skills, and reliability.

A key member of the Quality Control department, the Chemical Analyst leads immunochemistry and raw material analysis using techniques including Karl-Fischer, FT-IR, HPLC, and electrophoresis across pharmaceutical plasma-derivative products. Collaborating across international project teams and the broader Quality function, this role strengthens the organisation's cGMP compliance posture and supports continuous improvement of QC procedures and systems.

Functions

• Carry out raw material, in-process, and finished product chemistry and immunochemistry analysis.
• Perform raw material QC using Karl-Fischer, FT-IR, and NIR techniques.
• Conduct testing in relevant fume hoods and safety cabinets as required.
• Ensure laboratory processes, equipment, and services are installed, qualified, and maintained in an operational and safe state.
• Participate in the verification, validation, and technical transfer of analytical testing procedures.
• Ensure all cGMP, specifications, procedures, and guidelines are followed.
• Investigate out-of-specification, out-of-trend, and non-conformance events, and actively lead subsequent corrective actions as required.
• Participate in and take responsibility for QC-related CAPAs.
• Adhere to the QC documentation system and prepare and review document change requests as required.
• Develop, improve, and implement QC procedures, processes, and systems, and support continuous improvement initiatives across the Quality department and other functional areas.
• Participate in international project teams relating to QC and wider quality activities.
• Adhere to safety standards, maintain the laboratory in a clean and safe condition, and prepare for and support regulatory and internal inspections and audits.

Experience & Qualifications

• Bachelor's degree in Chemistry, Biochemistry, or a closely related scientific field.
• Experience with investigating and determining the root cause of out-of-specification and out-of-trend events and writing thorough investigational reports.
• Experience in method transfer and verification and validation.
• Experience with statistical analysis, including use of Minitab.
• Knowledge of specific product analysis techniques, including IC, AA, GC, flame-photometry, and Kjeldahl, is an advantage.
• Knowledge of raw material analysis techniques, including Karl-Fischer, FT-IR, and NIR, is an advantage.
• General knowledge of pharmaceutical plasma-derivative process, equipment, and chemical control.
• Strong knowledge of analytical techniques for biologics or protein-based therapeutics.
• Knowledge of and proficiency in a wide array of analytical techniques, including HPLC, spectrophotometry, and electrophoresis.
• Strong technical writing skills.
• Strong interpersonal, organisational, analytical, and problem-solving skills.
• Excellent verbal and written communication skills.

Ongoing product quality and regulatory confidence depend on the Chemical Analyst, who executes pre-validation and implementation of physical and chemical analytical methods, leads root cause studies, and delivers training internally and across sites. Based within a laboratory environment operating to ISO 17025 standards, this role serves as a content expert in audits and enables the organisation to maintain method performance and compliance across dairy industry production processes.

Accountabilities

• Perform pre-validation and implementation of physical and chemical analytical methods at laboratories.
• Execute improvements to physical and chemical analytical methods.
• Prepare and implement new equipment for operation.
• Report, interpret, and justify performance characteristics of analytical methods.
• Support and lead root cause studies.
• Provide training internally and across sites.
• Participate in audits as a content expert.

Background & Experience

• MSc or BSc in Analytical Chemistry, Physical Chemistry, Chemical Engineering, or Food Technology.
• Experience with validation projects to ISO 17025.
• Profound knowledge of instrumental techniques, including GC, MS, LC-MS, ICP, laser diffraction, and rheometry.
• Experience with measurement of physical properties, including viscosity, instant properties of powders, particle size distribution, and water activity, is an advantage.
• Basic understanding of production processes in the dairy industry and quality parameters required for product release.
• Basic project management skills to run small-scale projects or perform root cause analysis.
• Fluency in English, both verbal and written.
• Proficiency in Dutch is strongly recommended.
• Ability to facilitate and deliver training internationally.
• Ability to work effectively in a multidisciplinary team.

As the Chemical Analyst, this role leads the testing of components, raw materials, bulk samples, and finished products using FT-IR, UV-Vis, HPLC, TOC, and DSC in compliance with cGLP, cGMP, and regulatory requirements. The Quality Control team relies on this work to maintain accurate documentation, meet customer service standards, and support method transfer and qualification studies that underpin manufacturing plans.

Key Deliverables

• Test and analyse components, raw materials, bulk samples, CIP samples, water systems, and finished products using correct procedures in compliance with cGLP, cGMP, health and safety, SOPs, and environmental and regulatory requirements.
• Deliver high-quality customer service by testing components, raw materials, bulk, and finished products in an efficient and timely manner.
• Process, maintain, and archive all QC documentation accurately and in full to achieve customer service and GMP compliance.
• Maintain training records accurately, ensuring compliance with regulatory and business standards.
• Monitor and purchase laboratory consumables to ensure availability for timely testing of all samples.
• Ensure performance of instrument maintenance and calibration checks.
• Assist with the method transfer process, ensuring timely completion in line with manufacturing plans.
• Assist with qualification studies on existing and new methods.
• Establish performance and development goals.

Technical Qualifications

• Degree in a relevant discipline and relevant position-specific experience.
• Pharmaceutical experience operating to regulatory standards is desirable.
• Knowledge of cGMP, GLP, regulatory requirements, and health and safety standards.
• Good knowledge of laboratory instrumentation, including FT-IR, UV-Vis, HPLC, TOC, and DSC.
• Strong communication and teamwork skills.
• Ability to deliver high performance standards in quality, safety, cost, and customer service.
• Excellent attention to detail.

Chemical Analyst conducts testing and inspection of intermediate and finished petroleum products, process waters, and wastewater samples in a hydrocarbon analytical laboratory operating under ISO 9001 or ISO 17025 quality management systems. The work directly supports unit operation, corrosion control, and environmental compliance by delivering accurate data interpretation, instrumentation troubleshooting, and laboratory quality management documentation.

Role Responsibilities

• Work safely in a hydrocarbon and water analytical laboratory, ensuring the safety of self and others.
• Conduct testing and inspection of intermediate and finished products to evaluate quality or performance, and analyse gas samples.
• Analyze unknown sludge and scale samples.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on the appropriateness of data for release.
• Interpret qualitative and quantitative data and guide its use.
• Analyze process waters for unit operation and corrosion control.
• Analyze wastewater samples to ensure compliance with environmental standards.
• Complete documentation to support testing procedures, including data capture forms, equipment logbooks, and inventory forms, in accordance with the laboratory quality management system.
• Prepare and standardise solutions for use in chemical analysis.
• Standardise and calibrate all instrumentation before use.
• Maintain laboratory and technical equipment at analyst level and escalate faults beyond self-level of authority for appropriate action.

Minimum Qualifications

• Bachelor's degree in Analytical Chemistry.
• Minimum of 7 years of experience as an analytical chemist in a petroleum laboratory operating under a certified quality management system, such as ISO 9001 or ISO 17025.
• Sound knowledge of the chemical composition, structure, and properties of substances and of chemical processes and transformations, including uses of chemicals, interactions, danger signs, production techniques, and disposal methods.
• Proficiency in all aspects of modern instrumental methods.
• Practical ability in troubleshooting of instrumental and chemical analysis.
• Proficiency in method development protocols and associated documentation skills.
• Expertise in laboratory information management systems.
• Business-level spoken and written English.

The Chemical Analyst owns the classification of hazardous materials and the analysis of chemical process hazards across complex building and facility environments, serving chemical processing and manufacturing clients. Reporting into a collaborative technical team and interfacing directly with clients, this role enables organisations to achieve code compliance and implement sound hazardous material management strategies through engineering judgment and regulatory expertise.

Key Responsibilities

• Classify hazardous materials and analyse chemical process hazards.
• Prepare hazardous material inventory statements and hazardous material management plans, and associated reports.
• Develop engineering judgment letters, alternate materials, method justifications, compliance strategies, and code interpretations for complex code issues.
• Support multiple projects concurrently in a collaborative team environment and interface directly with clients.
• Participate in and lead technical teams and serve as a technical resource to internal staff.
• Participate in internal training programmes, quality assurance programmes, and jurisdiction presentations.

Education & Experience

• Bachelor of Science degree in Chemistry, Chemical Engineering, Mechanical Engineering, or a related engineering discipline with extensive chemistry coursework.
• Master of Science degree in Chemistry or Chemical Engineering is an advantage.
• 3–8 years of direct work experience in a chemistry laboratory, chemical processing facility, pharmaceutical facility, or chemical engineering design team.
• Knowledge of how chemicals are used and stored.
• Knowledge of chemical reactions and process hazard analysis.
• Knowledge of the International Fire Code is an advantage.
• Pharmaceutical and FDA knowledge is an advantage.
• Awareness of building codes and safety standards is an advantage.
• Strong analytical, communication, and organisational skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.