Job Description

JOB TITLE: SPECIALIST, EXTERNAL QUALITY ASSURANCE, BATCH DISPOSITION

LOCATION: Norwood, MA

DURATION:  Temp to Perm

HOURS: Sunday-Thursday 7am-3pm

PAY RATE: $35-45/hr

SUMMARY: The individual in this role will be responsible for providing Quality support in batch disposition related to external aseptic fill/finish activities. The individual will work with contract manufacturing and internal functions to ensure robust processes and systems are implemented in support of CMC development programs in conjunction with commercial filling milestones. This individual will execute based upon implemented quality systems / standards. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.

HERE'S WHAT YOU’LL DO: 

• Perform all activities required for commercial and clinical batch disposition
• Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
• Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
• Support Manager to collect and report targeted metrics for Management Review
• Support Quality Agreement review with contract manufacturers
• Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
• Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations
• Conduct internal audits, track progress, and trend results
• Provide guidance on GMP manufacturing from Phase I to Commercial
• Support Annual Product Review report generation and approval as needed
• Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.) as needed

HERE’S WHAT YOU’LL BRING TO THE TABLE:

• BS with at least 4 years of experience, or a master’s level degree and 2 years’ experience in the pharmaceutical/biotech industry
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
• Experience working with CMOs, vendors, and relationship management preferred.
• Experience working with aseptic fill and finish of vials preferred.
• Familiarity with PDA Technical Reports 22, 26, 60, and 79 preferred.
• Knowledge of late-stage pharmaceutical development and validation principles preferred
• Excellent judgment and ability to communicate complex issues in an understandable way.
• Outstanding communication skills (verbal and written).
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
• Travel up to 10%

Company Description

Connexion is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.