The Quality Assurance Specialist for Small molecule is responsible for management of deviations and customer complaints including coordination, review / approval of deviations and complaint investigations.
Primary activities include, but are not limited to:
- Review and approve deviation reports and document in *** quality systems as appropriate.
- Notify External Manufacturing sites of customer complaints and internal complaints upon receipt.
- Review and approve complaint investigations and document in *** quality systems.
- Follow up with External Partners to ensure investigations are completed in a timely manner and escalate for support as necessary.
- Collaborate with other team members to perform second person reviews of stability protocols when necessary.
- Assist with reference standard requests as needed.
Qualifications:
- Education: BA/BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) with minimum 4-6 years of relevant experience within complaints management, deviations and complaint investigations.
- Previous experience within the pharmaceutical industry or Medical Devices Combination Products with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control.
- Must have working knowledge of regulatory expectations for the manufacture and/or testing of pharmaceutical products and/or Medical Devices Combination Products, with experience in quality, manufacturing, process validation and/or process technology transfer processes.
- Experience with Quality functions through execution of activities such as investigations, corrective actions, complaints management, quality system management, etc.
Software:
- Knowledge and competency with SAP and Trackwise.
- Familiarity with Ariba and Veeva Vault a plus.
Personality:
- Independent
- Team player
- Flexible and adaptable
- Prioritizes timelines
- Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills.