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Specialist, External Quality Assurance (4 days REMOTE)

Norwood, MA 02062

Posted: 01/11/2023 Employment Type: Contract Job Category: QA/Automation Job Number: 536127 Is job remote?: No Country: United States

Job Description

The Role:

Seeking a Specialist of Contract Manufacturing Organization (CMO) Upstream Operations within the External Quality Assurance department based in Norwood, MA location. The individual in this role will be responsible for providing quality support and lead Quality improvement initiative related to external manufacturing activities including custom manufactured raw materials. The individual will work directly with contract manufacturing and internal functions to ensure robust processes and systems are implemented in support of Modernas CMC commercial programs. This individual will develop and implement quality systems / standards. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems. This is a contract position.

Heres What Youll Do:
  • Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.).
  • 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 and approve validation protocols and reports to ensure compliance.
  • Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans.
  • Support disposition of custom raw materials.
  • Review stability protocols and reports.
  • Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations.
  • Make quality decisions that may impact operations, ensuring appropriate escalation to management when needed.
  • Communicate project requirements and issues to Quality Management.
  • Support Contract Manufacturing sites and perform Person-in-Plant duties as required.
  • Provide guidance on GMP manufacturing from Phase I to Commercial.

Heres What Youll Bring to the Table:
  • BS preferred with at least 5 years experience, or a Masters level degree and 2 years experience in the pharmaceutical/biotech industry within Quality Assurance or Quality (Assurance) exposure
  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
  • Experience working with CMOs, vendors, and relationship management preferred.
  • Experience working with small molecule manufacturing preferred.
  • Excellent judgment and ability to communicate complex issues in an understandable way.
  • Outstanding communication skills (verbal and written).
  • Auditing experience is a plus.
  • Familiarity with PDA Technical Reports 22, 26, 60, and 79 preferred.
  • Knowledge of late-stage pharmaceutical development and validation principles preferred.
  • Ability to manage multiple projects in a fast-paced environment.
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
  • Potential travel up to 10%.
Pay range: 35-55/hr
Salary will be commensurate iwth experience
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