Proclinical is currently recruiting for a QA Incoming Release Specialist with a pharmaceutical company located in Marietta, PA.
- Act as the Quality Assurance site subject matter expert for all questions and issues related to incoming release and SAP utilization for release activities
- Key contact for internal departments and other sites, receive information and distribute as appropriate
- Act as the site consultant when issues arise
- Perform QA review and final approval of deviations
- Be site review participant for GSOP development to provide key review output from Marietta to assure the site needs are being addressed and improve our standing with GQA
- Be owner for local SOPs on release and sampling of purchased materials as well as QA approver/authority for SOPs relating to WHS receipt, ensuring compliance with CFR requirements and higher level documents, consistent use of SAP across QA Incoming Release WHS departments from different sites, consistency/ clarity between all relevant processes, ease of use for local departments, clear traceability, visibility and accuracy of decision-making processes
- Ensure accurate and timely release of purchased lots within SAP by maintaining visibility to purchased material status as it progresses through SAP, understanding release criteria outside of Marietta control and identifying correct contact for updates and problem resolution, escalating known issues that will hold materials from release, timely closure of QA Inspection Plans, ensuring consistent data packs for release - verifying completeness of documentation - challenging variations in SAP data or presentation - always ensuring 100% clarity on releasability of a lot
- Act as the Quality Assurance site subject matter expert for Marietta Spare Parts, ensuring adherence to internal procedures, policies, standards and FDA regulations
- Assist with impact assessment of relevant site deviations
- Ensure all GMPs, validation, quality, safety and environmental regulations are met. Adhere to all safety guidelines and procedures.
Skills and Requirements:
- BS or BA in Microbiology, Biochemistry, Chemical Engineering or relevant technical discipline
- Degree in other discipline if sufficient technical depth has been achieved from professional experience
- 1-year pharmaceutical industry experience with 1 year in licensed biopharmaceutical or biological products
- 1 year in quality organization
- SAP knowledge
- QA Incoming Release experience
- Excellent organizational skills and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy
- Excellent communication skills and a highly effective team worker
- Versed in GMP's, NIH and WHO Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance
- Demonstrate a serious commitment to accuracy, integrity and quality while meeting goals or deadlines
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.