• Review data and reports associated with development and transfers of analytical methods
• Review data from testing of in-process and drug substance/drug product samples
• Verify that calculations and documented information are present, complete, and accurate
• Verify that all analyses are performed per methodology and are following GMP requirements
• Understand experiments and assays used to develop methods and/or test samples, maintain and update knowledge of instrumentation
• Keep current with cGMP and other regulatory requirements
• Manage QC and analysis of qPCR data and support the team with the logistics of data handling. 
• Analyze qPCR data (manual calling of automated output) 
• Approve qPCR data or redirect samples to retesting 
• Run basic statistics on dashboard data 
• Support the team with the logistics of data handling 
• Support data analysts in troubleshooting

Skills: Data Review, GMP Compliance, Method Validation, qPCR Analysis, Regulatory Updates, Statistical Analysis, QC Management, Troubleshooting Support

• Maintain certification for all levels of complexity of data in area of assignment
• Maintain and document timely and thorough reviews of data assigned to the area
• Participate in periodic review of procedures associated with the review of data or data practices within assigned area(s)
• Work independently with data generators to understand the data being reviewed, obtain appropriate clarifications and/or corrections and ensure investigations are opened where needed in a timely manner
• Maintain review records including information regarding defects, to aid in tracking/trending errors and improvement opportunities
• Maintain detailed record of status/progress of records in review to allow for transparency into the process
• Review analytical data to ensure ALCOA+.
• Review time of use logs on cGMP instrumentation and other analytical equipment.
• Review audit trails on computer systems used to acquire and process data from instrumentation (e.g Empower)
• Ensure compliance of testing with laboratory procedures, test methods and protocols.
• Work with laboratory personnel to correct any errors and omissions in GMP documentation.
• Promote a cGMP culture and adheres to safety policies.
• Engage in continuous improvement activities and adhere to department goals/metrics.

Skills: Data Certification, Procedure Review, Data Clarification, Record Maintenance, Analytical Review, Audit Compliance, Documentation Correction, Continuous Improvement

• Verify data in the clinical database using CRFs and DCFs
• Receive feedback from HOD, learn from errors and apply corrections
• Ensure the completeness and validity of the clinical trial data that has gone through data entry
• Respond and complete data queries and clarifications identified by the system or through manual checks as identified in the data validation guidelines
• Propose data clarification forms to clinical trial sites for mentor review
• Guide new candidate to carry out data entry and validation
• Interact with the clients regarding data quality issues
• Participate in the development of project related documents (e.g
• Data Entry guidelines, Data validation guidelines etc.) Maintain appropriate validation documentation
• Investigate and troubleshoot problems and determine solutions

Skills: Data Verification, Feedback Implementation, Data Validity, Query Resolution, Data Clarification, Data Training, Client Interaction, Document Development

• Review of analytical records generated during testing of API, finished product, in-process, and stability for compliance to current Good Manufacturing Practices (cGMP), internal procedures and USP guidelines.
• Ensure compliance with good documentation practices and verify calculations, appropriate test methods/specifications applied to sample testing.
• Review of analytical data for accuracy, completeness, and FDA compliance. 
• Review and approval of controlled documents such as SOPs, protocols, test methods, and specifications.
• Reviews internal and external documents such as Deviation, Out of Specification (OOS) Investigations, CAPAs, and Quality Protocols
• Maintain a track and status of documents and data packages submitted for review.
• Review all other study related documentation: medical screening files, pharmacy labels and files, final report tabulations and PK STAT input and output 
• Observe, on a random basis, clinical procedures during the conduct of studies, sample bundling and shipping process
• Provide reports of the reviewed data to relevant personnel/department
• Ensure all prepared study source documents and/or forms are in accordance with protocols, SOPs and regulations

Skills: Compliance Review, Documentation Verification, Data Accuracy, Document Approval, Deviation Analysis, Document Tracking, Procedure Observation, Report Preparation

• Review of documents associated with the testing of Novavax Drug Product and Drug Substance that has been generated by CMOS and Outside Testing Laboratories (OTL)
• Responsible for the efficient and thorough review of documentation associated with Test Method Qualifications, Test Method Validations, Test Method Transfers and Technology Transfers on an as-needed basis (secondary responsibility)
• Ensure that deadlines for data review are met and be able to identify potential causes of process delays and/or constraints in advance
• Conduct analysis and periodic reviews of written procedures and submit procedural revisions
• Attend regularly scheduled meetings to represent Novavax External QC department and interact with CMOs
• Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards
• Work independently and carry out tasks with general instruction
• Review study files after completion and ensure that they are accurate and legible according to protocol, SOPs and regulations

Skills: Documentation Review, Test Method Oversight, Deadline Management, Procedural Revisions, CMO Collaboration, Systems Evaluation, Independent Tasking, Study File Review

• Relevant industrial experience in GMP lab.
• Experience in HPLC and capillary electrophoresis 
• Experience with protein methods (SDS-PAGE, Western blot, IEF, CE,)  
• Experience working in a regulated GMP environment 
• Strong technical writing, presentation and troubleshooting skills.
• Ability to work independently within a team-based environment.
• Advanced experience in Excel, able to perform basic statistics and data analysis in Excel
• Team player with an open and collaborative mindset, proactive

Qualifications: BS in Statistics with 4 years of Experience

• Relevant Clinical background or Data Management experience.
• Possess sufficient clinical knowledge to assess if participant data is scientifically and clinically valid.
• Prior InForm EDC experience.
• Proficient in reviewing large scale listings in Microsoft Excel
• Proficient in accessing internal data systems
• Basic understanding of how data points from different fields interact and how data collection impacts analysis.
• Strong attention to detail.
• Ability to work independently and as part of a team.
• Ability to prioritize and adjust work priorities quickly as needed to meet deadlines

Qualifications: BS in Data Science with 3 years of Experience

• Experience in pharmaceutical analytical lab and reviewing QC data.
• Experience in Generic Pharmaceutical industries 
• Knowledge of Good Documentation practices and knowledge in USP/ICH/FDA
• Ability to learn quickly and decision making skills
• Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
• Basic knowledge of US and EU cGMP regulations/guidance.
• Strong knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements.
• Ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects

Qualifications: BS in Information Technology with 4 years of Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, and experience.) 
• Knowledge of applicable regulatory authority, compendia and ICH guidelines
• Knowledge of Analytical techniques such as: HPLC, GC, IR, XRD, PSD, and KF
• Solid understanding and knowledge of general chemistry and separation science
• Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
• Technical knowledge and understanding of laboratory procedures, methodology and standards
• Ability to independently review laboratory reports and analytical methods
• Ability to utilize Microsoft Suite, Excel and Word to perform tasks with SharePoint, Empower, and Kiteworks 
• Ability to provide clear and concise feedback and/or documentation of results
• Ability to write clear and concise technical documents
• Ability to independently optimize analytical methods
• Strong written and oral communication skills
• Time management and project management skills
• Ability to work in a collaborative work environment with a team
• Able to demonstrate being detail oriented and able to deal with multiple and changing priorities

Qualifications: BS in Biostatistics with 5 years of Experience

• Directly related experience in the pharmaceutical/biopharmaceutical or related industry.
• Strong technical writing capability, can transfer ideas into scientifically sound and efficient study protocols and reports.
• Proficient and professional communicator, verbally and in writing.
• Demonstrated technical competence, can analyze data and interpret results to make scientifically valid conclusions.
• Strong organizational and interpersonal skills and the ability to work collaboratively with others.
• Proficient in complex procedures and problem solving.
• Strong commitment to teamwork, proven leadership skills, independence and initiative.
• Extensive knowledge of biomolecular analysis, practical experience with a range of analytical instrumentation / methodology including such methodologies as FTIR, GC, HPLC, ELISA, immunological assays, spectrophotometric analysis, USP/EP testing, wet chemistry.
• Proficient in Microsoft Office - Word, Excel, PowerPoint.
• Comprehensive knowledge of pharmaceutical GLPs and GMPs.
• Comprehensive knowledge of laboratory techniques and safety precautions.
• Comprehensive knowledge of regulatory/industry guidance.

Qualifications: BS in Computer Science with 6 years of Experience