Position Overview:
The Senior Quality Control Analyst will be responsible for conducting development, validation, routine testing and GMP review of analytical assays in compliance with all applicable quality systems and current cGMPs within the Quality Control department. They will operate as a core member of project teams to support improvements to QC systems and processes including assay performance, improving compliance, and efficiency.
The primary goals of Quality Control are: to lead the execution of release and stability testing for commercial and clinical GMP, execute assay validation and assay transfer studies and critical reagent qualification studies; the implementation and maintenance of laboratory control procedures and compliance; raw materials and laboratory investigations.
For Gene Therapy Innovation Center (GTIC) Specific Needs:
Lead method validation activities prior to GTIC transfer to support the GTIC Validation Master Plan. Lead change controls for method revisions post validation to ensure continued performance of test methods in support of asset post-PPQ prior to GTIC method transfer. Author (review/approve) and execute method transfer protocols to ensure analytical QC readiness at GTIC in line with GTIC manufacturing and project timelines. Support of CQV activities in GTIC by providing QC ownership on documents such as IQ/OQ. Lead bridging activities for equipment changes in support of GTIC readiness prior to equipment purchase to support facility and laboratory start-up. Lead training strategy and serve as the SME for training of new employees and contractors in associated methods for GTIC readiness.
Job Duties:
- Performs quantitative analytical assays and is highly proficient on the associated method and instrumentation
- Executes method validation and transfer studies
- Perform routine testing in support of release and stability studies; peer reviews data
- Acts as a resource to junior QC analysts (and contractors), both from a technical and GMP-compliance standpoint.
- Participate in establishing and maintaining laboratory systems and controls. Active in maintaining the compliance of the laboratory
- Author GMP documents such as analytical methods/forms, technical protocols/reports, CAPAs, and change controls
- Independently complete complex deviation reports and investigations
- Conduct wide variety of assays or tests required to characterize and qualify assay-specific reagents, such as qPCR primers and probes.
- Provide routine support and communication to groups external to QC. Interfaces with other departments within the organization and participates on project teams. Act as a delegate for the QC Lead/Leader at meetings, including GTIC project.
- With guidance, act as the Subject Matter Expert during regulatory audits for their respective assays and will interact directly with regulatory auditors.
Basic Minimum Qualifications:
- BS degree in the biological or chemical sciences with a minimum of 5+ years related laboratory experience in the pharmaceutical industry; or MS/PhD in the biological or chemical sciences with a minimum of 2+ years related laboratory experience in the pharmaceutical industry.
- Experience working in a GMP environment is required
- Hands on experience in assays performance including: HPLC, QPCR, PCR, mammalian cell culture techniques, tissue-culture assays, ELISAs, Western blots, agarose gel electrophoresis, protein gel electrophoresis, silver staining, etc.
Position is Full Time, Monday-Friday, 8am-5pm with overtime as needed. Candidates currently living within a commutable distance to Philadelphia, PA are encouraged to apply.
What we offer:
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goal-based bonus & eligibility for merit-based increase
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
