Senior Quality Specialist
- • Provides a Quality Oversight for the production areas including Manufacturing, Warehouse, Laboratories, Facilities and Engineering.
• Perform rapid response, walk thrus, process assessments, and change over walk-thrus
• Review GMP related documentation such as SOPs, MC, Deviation/CAPAs, executed solution batch records and executed BDS process batch records Master Batch Records, Glass Wash and Autoclave records, cleaning logs, temperature charts, equipment alarms and Technical Reports. Approves any changes associated with these documents.
• Review EM and water data for facility and EM for bulk fills
• Review executed protocols and summary reports for GMP laboratory equipment, manufacturing equipment, facility utilities, process controllers, IT systems and process validation
• Support change control oversight under the supervision of Sr. QA Specialist
• Support/Perform L1 and L2 audits and Inspection Readiness efforts making sure that area logbook and documentation is accurate and review in a timely manner
• Review Validations documents.
• Work across multiple value streams to drive continuous improvement and promote quality culture. Utilizes and continuously improves the GPS standards (i.e. 5s, standard work, problem solving, Gemba, process confirmations, and performance management) towards the goal of Zero Accidents, Zero Defects, and Zero Waste
• Work closely with cross site teams to drive performance of product disposition.
• Represent QA on product/project teams, in work group meetings, participate in facility design teams and specific drug product development teams
• Performs other functions as necessary or as assigned.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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