Data Review Specialist
West Pharmaceutical Services
Summary
In this role, you will be responsible to independently provide review of analytical data for GMP compliance, accuracy, completeness, and adherence to applicable procedures and regulatory requirements. This role also requires a working knowledge of common analytical techniques and laboratory testing practices, including familiarity with laboratory data review and interpretation of analytical test results. In addition, mentor others and provide quality-minded direction as needed.
Job description
Essential Duties and Responsibilities
- Perform cGMP Data Review on the analytical data generated in WSS which may include raw materials and finished goods, product performance, container closure integrity, particle analysis, and/or microscopy/investigation.
- Review data from various analytical techniques in the laboratory including but not limited to CCI testing, USP/EP/JP/YBB Compendia Testing, ISO Testing, Instron and Zwick, ICP, DSC, TGA, IR, UV, AA.
- Review the analytical raw data generated by first and second shift laboratory operations according to established methods, protocols, compendia and work Instructions for cGMP compliance.
- Review Electronic Data and Audit Trails for Data Integrity compliance.
- Support new GMP compliance guidance and data integrity initiatives.
- Collaborate with Laboratory Services, Project Management, and Quality.
- Maintain working knowledge of computer software packages including MS Office suite, Adobe, Master Control, LIMS, Empower and LMS.
- Collaborate with analysts on proposed path forward regarding documentation questions.
- Review Internal and External Client Reports generated from lab operations from multiple analysts utilizing multiple techniques for cGMP compliance and Data Integrity.
- Review Lab Operations Methods, Protocols, and Work Instructions for cGMP Compliance.
- Manage projects from Protocol to final report.
- Review and comment on Work Instructions, Preformatted Notebooks, and Forms for Lab Operations.
- Keep current with new GMP compliance guidance and internal QA procedures.
- Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
- Willingness to learn and review new analytical techniques.
- Meet individual and departmental goals as required.
- Conforms with and abides by all regulations, policies, work procedures, instructions, and safety rules.
- Exhibits regular, reliable, punctual, and predictable attendance.
Education
Bachelor's degree in Chemistry or a related scientific field, preferred.
Work Experience
3+ years of experience in data review, laboratory, and/or cGMP environment.
Preferred Knowledge, Skills and Abilities
- Ability to work independently, multitask and thrive in fast-paced environment.
- Experience with managing Document Control activities within a regulated industry.
- Excellent written and verbal communication skills.
- Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint.
- Familiarity with Master Control, SAP/ERP system, and SharePoint.
- Must have effective problem-solving and interpersonal skills.
Additional Requirements
- Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
- Must maintain the ability to work well with others in a variety of situations.
- Effectively communicate and interface with various levels internally and with customers.
Requirements
- Bachelor's degree in Chemistry or a related scientific field, preferred
- 3+ years of experience in data review, laboratory, and/or cGMP environment
- Working knowledge of common analytical techniques and laboratory testing practices
- Familiarity with laboratory data review and interpretation of analytical test results
- Ability to work independently, multitask and thrive in fast-paced environment
- Experience with managing Document Control activities within a regulated industry
- Excellent written and verbal communication skills
- Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint
- Familiarity with Master Control, SAP/ERP system, and SharePoint
- Effective problem-solving and interpersonal skills
Benefits
- Health insurance
- Paid time off
- Tuition assistance
- Leadership development
- Performance-based bonuses
- Service recognition
- Employee appreciation initiatives
Company overview
West Pharmaceutical Services, Inc. is a global leader in the design and manufacture of innovative, high-quality injectable pharmaceutical packaging and delivery systems. Founded in 1923 and headquartered in Exton, Pennsylvania, the company serves as a trusted partner to both established and emerging drug developers, ensuring the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients worldwide. With approximately 10,000 team members across 50 sites globally, West delivers billions of components and devices annually, supporting pharmaceutical companies in their mission to bring critical therapies to market. The company operates as a publicly traded entity on the New York Stock Exchange (NYSE: WST) and is included in the S&P 500 index, generating approximately $2.95 billion in net sales in fiscal year 2023. West specializes in pharmaceutical packaging systems and delivery systems, focusing on injectable drug containment solutions that meet stringent regulatory requirements and quality standards.