Quality Assurance Specialist

The Contractor Quality Associate, Biologics plays a critical role in data management of commercial biologics executed by contract laboratories. The position requires familiarity with data review, data management in Excel or Minitab, and understanding of LIMS systems. Some understanding or familiarity with bioanalytical methods such as, but not limited to, compendial, HPLC, ELISA, CE, real-time PCR, spectrophotometry, SDS-PAGE, and HPLC methods is valuable. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.

This role will be a Hybrid 2 Days On Site

This role will be a Hybrid 2 Days On Site

Essential Functions

• Data review and management of routine testing executed by contract laboratories for commercial biologics, including:

1. Data review and management to support use of electronic systems such as Veeva Quality eDocs, Minitab.
2. Perform and support data trending, interpretation, and statistical analysis of commercial release and stability studies, for assay controls or reference standards and invalid assay trending.
3. Monitoring release and stability data to ensure data integrity, regulatory compliance, product quality, and on-time completion.
4. Acting as the technical reviewer of data sets, quality records, and lab investigations generated by contract test labs.
5. Authoring CoAs, technical reports, and internal quality records in accordance with regulatory requirements.
6. Serving as the SME for product-specific test methods for internal and external quality control.
7. Collaborating frequently with internal and external cross-functional groups to provide status updates, workflows, and timelines for routine testing activities. These groups include CMOs/contract test labs, manufacturing operations, quality, regulatory, and program management.
8. Monitoring product-specific reference standard programs in collaboration with the network Analytical/Quality experts to sustain routine testing activities. This includes driving efforts for reference standard qualification, annual re-qualification, and distribution to contract test labs.
9. Supporting analytical method validation and method transfer activities.

Requirements

Education:

• Associate degree (required); BS/BA in pertinent life sciences or closely related field (preferred)

Technical:

• 3 years of pharmaceutical/biotech working experience in a cGMP Quality Control, analytical development, analytical transfer, or validation department in an FDA-regulated industry.
• Familiarity with data trending and monitoring controls.
• Hands-on experience within a bioanalytical lab. Familiarity with equipment and test methods which may include HPLC, CE, PCR, ELISA, gel-based assays, and other compendial assays used to test biopharmaceuticals.
• Familiarity with Method Validation, Analytical Transfers, or laboratory investigation experience.
• Thorough understanding of principles, practices, and standards for biopharmaceutical testing.
• Well-versed in ICH and regulatory requirements for quality as it relates to QC operations, laboratory compliance, data integrity, and quality events.
• Experience performing statistical analysis of data sets using software such as JMP or Minitab is a plus.
• Proficient in Microsoft Office tools, Minitab, Veeva Quality systems.

Must Possess:

• Strong organization and communication skills and technical writing skills.
• Must be self-directed, goal-oriented, and quality conscious.
• High attention to detail with the ability to rapidly see the big picture and assess the impact of data and/or decisions.