Our client is looking for a Manufacturing Compliance Specialist to support Manufacturing activities including deviation investigation and report composition, CAPA creation and closeout, and communication of compliance strategy to stakeholders.
Our client is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of their dedication to building and empowering their internal teams, our client is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, they deliver deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. They forge exceptionally strong partnerships with their clients, and they never lose sight of their pledge to deliver a reliable and compliant drug substance supply, Right, On time. This is a direct hire opportunity with excellent benefits and a competitive salary!
Perform root cause analysis on manufacturing deviations; create deviation reports.
Maintain facility GMP compliance; assist in ensuring regulatory inspection readiness.
Work closely with other team members to ensure project progression; represent the Manufacturing department’s interests on multidisciplinary project teams.
Serve as liaison between multiple teams including manufacturing, quality, and process development.
Clearly communicate compliance strategy and rationale, both verbally and in written communications.
Lead investigations for manufacturing issues, bringing them to a resolution under minimal direct supervision.
Initiate appropriate corrective action/preventative action (CAPA) to prevent recurrence of deviations.
Work closely with manufacturing operations and QA team to drive CAPAs to timely closure.
Work within site quality and asset management systems.
Support quality system programs such as Deviation, CAPA, and Change Management.
Review records and assist in record closure for Lot Disposition process.
Update and revise site manufacturing SOPs.
B.S. in Chemistry, BioChemistry, Biology or related scientific discipline preferred.
Minimum of 5+ years’ experience conducting investigation and root cause analysis in a pharmaceutical or FDA/GMP environment required.
Experience using GMP compliance in a clinical/commercial manufacturing environment required.
Experience using quality management software (Mastercontrol, Trackwise, etc.) preferred.
Experience with asset management software (Blue Mountain, Maximo, etc) preferred.
Equivalent education and experience may substitute for stated requirements.
Strong knowledge of FDA and EU regulations for APIs and Drug Products.
Ability to understand and apply GMP regulations as they relate to manufacturing.
Strong technical writing skills.
VanderHouwen is an award-winning, Women-Owned, WBENC certified professional staffing firm. Founded in 1987, VanderHouwen has been successfully placing experienced professionals throughout the Pacific Northwest and nationwide. Our recruitment teams are highly specialized in either Technology and IT, Engineering, or Accounting and Finance career markets. Our recruiters value building meaningful, professional relationships with each candidate as well as developing honed knowledge of companies' staffing needs and workplaces. Partner with us to land your next exciting career.
VanderHouwen is an Equal Opportunity Employer and participates in E-Verify. VanderHouwen does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by applicable local, state or federal civil rights laws.