
Quality Assurance Specialist
hace 7 días
Job Description
We are seeking a Quality Assurance Specialist to support our Quality Assurance program with minimal supervision. The ideal candidate will have experience in manufacturing process audits, batch record review, and quality compliance.
Responsibilities:
- Review and approve product manufacturing procedures (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Serve as Quality representative on incident triage teams.
- Approve Environmental Characterization reports and sanitary utility system releases.
- Review and approve: Planned incidents Work orders EMS/BMS alarms Non-conformance (NC) investigations and CAPA records Change controls Provide lot disposition and authorize lots for shipment.
- Represent QA on New Product Introduction (NPI) teams.
- Lead investigations and site audits to ensure compliance.
- Own and maintain site quality program procedures.
- Act as designee for the QA manager on local CCRB (Change Control Review Board).
- Support automation activities, facility programs, and environmental compliance.
- Collaborate with cross-functional teams to drive process improvements and ensure regulatory compliance.
Requirements & Qualifications:
- Doctorate Degree OR Master's Degree & 3+ years of directly related experience OR Bachelor's Degree & 5+ years of directly related experience OR Associate's Degree & 10+ years of directly related experience OR High School Diploma/GED & 12+ years of directly related experience
Preferred Qualifications & Skills:
- Manufacturing process audit & batch record review experience.
- Familiarity with DAI process, PASx/MES application, MAXIMO, SAP, and LIMS.
- Strong project management and organizational skills.
- Ability to initiate and lead cross-functional teams.
- Strong knowledge of manufacturing, distribution, validation, and process development.
- Experience interacting with regulatory agencies.
- Advanced data trending, evaluation, and compliance analysis.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, and database management).
- Strong communication, facilitation, and leadership skills.
- Ability to evaluate and resolve compliance issues independently.
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