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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: 536127-1 Country: United States Is job remote?: No

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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet domain (@theplanetgroup.com, @theplanetforward.com, @planet-technology.com, @planet-pro.com, @planetinteractive.com, @pfes.com, @launchcg.com, @planet-pharma.com, @planet-healthcare.com) - and not a domain with an alternative extension like .net, .org or .jobs.

The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Norwood, MA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Norwood, Massachusetts! Located just outside of Boston, Norwood offers a perfect blend of small town charm and big city amenities. From the historic Norwood Theatre to the lush trails of Francis William Bird Park, this area has something for everyone. Enjoy delicious New England cuisine, catch a game at Gillette Stadium, or explore the local art scene at Infinity Art Gallery. Join us in Norwood and discover endless growth opportunities and a supportive community that will help you thrive professionally. Start your job search today and take advantage of all that this exceptional region has to offer!
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