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• Provides Quality Oversight for the production areas including Upstream and Downstream Bulk Drug Substance Manufacturing, Warehouse, Laboratories, and Facilities
• Perform reviews of reports and data in support of regulatory filings.
• Reviews GMP related documentation such as SOPs, Technical Reports, Validation Reports
• Supports change control records under the supervision of QA Management
• Supports audits and Inspection Readiness efforts including making sure that area documentation is accurate and reviewed in a timely manner
• Works 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 and in work group meetings
• Performs other functions as necessary or as assigned
• Associates degree in Technical/Scientific discipline
• 1 to 2 years of Manufacturing, QA, QC, process/product development experience or similar
• Some knowledge of cGMP’s and other Regulatory requirements
• Demonstrate initiative and analytical problem-solving skills
• Ability to work well under high pressure and deadlines
• Must be flexible, adaptable, and a strong team player that fosters and promotes company Values, Behaviors and Strategies.
• Good verbal and written communication skills.
• Conflict resolution and interaction management skills
Per our client’s policy, individuals hired for this position must be fully vaccinated against COVID-19 unless otherwise prohibited by law. We comply with federal, state and local laws with regard to accommodations related to this policy.
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.