Senior Quality Assurance Specialist
hace 4 días
We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Quality Consulting Group. The ideal candidate will have a strong background in manufacturing process expertise, with a proven track record of ensuring the highest quality standards.
About UsQuality Consulting Group is a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry. Our company prides itself on delivering exceptional services and solutions that meet the ever-changing needs of our clients.
Salary InformationThe estimated salary for this position is $85,000 - $110,000 per year, depending on experience and qualifications.
Responsibilities- Review and approve product Master Production Records (MPRs)
- Approve process validation protocols and reports for manufacturing processes
- Request Quality involvement in incident triage teams
- Approve Environmental Characterization reports
- Release sanitary utility systems
- Approve planned incidents
- Represent QA on New Product Introduction (NPI) teams
- Lead investigations and site audits
- Own site quality program procedures
- Designate for QA manager on local Corrective Action Request Boards (CCRBs)
- Review Risk Assessments
- Support Automation activities and facilities programs
- Review and approve Work Orders and Emergency Management Systems/Batch Management System alarms
- Demonstrate ability to interact with regulatory agencies
- Approve Non-Conformance investigations and CAPA records
- Approve change controls
- Provide lot disposition and authorize lots for shipment
To be successful in this role, you will need:
- Bachelor's degree in a related field (Science or Engineering)
- 5+ years of experience in Quality Assurance and/or Manufacturing
- Strong knowledge of manufacturing and distribution processes, QA/QC, validation, and process development
- Demonstrated ability to interact with regulatory agencies
- Strong English technical writing skills
- Experience with Manufacturing Process Audit and Batch Record Review
- Familiarity with DAI process, PASx/MES application, MAXIMO, SAP, and LIMS
We offer a competitive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
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