Specialist QA
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Job Description
Job Description
Job Summary:
The Quality Assurance Specialist will support the organization s Quality Assurance program with minimal supervision, ensuring compliance with regulatory standards and promoting high-quality practices across manufacturing, process validation, environmental monitoring, and quality control. This role involves critical review and approval of product master plans, validation protocols, risk assessments, and change controls. The Quality Assurance Specialist will also lead investigations, oversee audits, and manage various quality records, while supporting automation and environmental programs.
Key Responsibilities:
- Product and Process Quality Oversight:
- Review and approve product master plans (MPs) and environmental characterization reports.
- Approve process validation protocols and reports for manufacturing processes, ensuring regulatory and quality standards are met.
- Release sanitary utility systems and approve planned incidents related to manufacturing.
- Quality Control and Compliance:
- Approve non-conformance investigations, CAPA (Corrective and Preventive Actions) records, and change controls.
- Provide lot disposition and authorize product release for shipment.
- Ensure compliance with quality protocols by managing risk assessments, supporting automation, and overseeing environmental programs.
- Cross-functional Quality Leadership:
- Represent Quality Assurance (QA) on New Product Introduction (NPI) teams.
- Lead investigations and site audits, developing corrective actions where necessary.
- Act as the designee for the QA manager on the local Change Control Review Board (CCRB).
- Collaborate with cross-functional teams to ensure quality initiatives align with organizational objectives.
- Documentation and Data Integrity:
- Own and manage site quality program procedures, ensuring documentation reflects current operational standards.
- Review and approve work orders, EMS/BMS alarms, and maintain data integrity.
- Support data trending, evaluation, and advanced data analysis to monitor and improve compliance.
Skills:
- Strong project management, organizational, and cross-functional team leadership abilities.
- Skilled in leading, influencing, and negotiating across multiple organizational levels.
- Proficient in manufacturing, QA, validation, and process development.
- Demonstrated ability to interact effectively with regulatory agencies.
- Strong verbal and written communication skills, including facilitation, technical writing, and presentations.
- Advanced data evaluation skills, including trending and compliance assessment.
Technical Requirements:
- Proficiency in word processing, presentation, database, and spreadsheet software applications.
- Ability to work independently while effectively collaborating across various organizational levels.
Requirements
Educational Requirements:
- Doctorate degree, or Master s degree with 3+ years of related experience, OR
- Bachelor s degree with 5+ years of related experience, OR
- Associate s degree with 10+ years of related experience, OR
- High school diploma / GED with 12+ years of related experience.
Preferred Qualifications:
- Strong background in Warehouse and Incoming Quality Control (QC) operations.
- Experience in quality oversight, quality records management (e.g., deviations, CAPAs, change controls), and familiarity with data integrity concepts.
- Scientific degree or background in sciences highly preferred.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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