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QA Specialist
101 Southcenter Court Morrisville, NC 27560 US
Job Description
Job Description:
- Provide Quality and Compliance oversight for manufacturing of commercial and investigational products through Shop Floor presence.
- Responsible for performing inspection and disposition of raw materials and components by:
- Working within our ERP system (Slingshot) to ensure compliant material release.
- Acquiring Certificates from Vendors to support Release per Master Specification.
- Reviewing the required documentation (CoA, CoC, CoS, etc.) to ensure that the material meets testing specification.
- Ensure rejected and or released materials are transferred to the appropriate areas by collaborating with appropriate stakeholders.
- Upon release, archiving the completed Mater Specification within document control room.
- Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents.
- Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry.
- Integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence.
- Be flexible and contribute positively to the team's success, take on additional tasks as required and adjust to changing business needs.
- Strong organizational skills and ability to work on multiple projects with tight timelines and minimal oversight.
- Working experience in KNEAT, SlingShot, Blue Mountain RAM and VEEVA is preferred.
- B.S. in chemistry, biological or pharmaceutical sciences, or related discipline
- At least 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
- Acquiring Certificates from Vendors to support Release per Master Specification
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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 Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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