Quality Assurance Associate

• Provides Quality oversight of Production activities, including compounding, aseptic filling, inspection, and labeling/packaging on the floor. • Provides Quality oversight of cleaning activities to ensure compliance with cleaning requirements. • Product label review and approval. • Oversight and confirmation compliance with Filling Operations, including line clearance, material status, aseptic technique, in-process quality attribute testing, documentation on forms, and batch records. • Verification of proper gowning by all personnel in all areas of Production. • Generation of deviations, issuance of CAPAs, and Change Controls in response to observations. • Oversee all Quality aspects on the floor. • Participate in regulatory audits if required. • Performs or assists process owners with the root cause analysis. • Responsible for generating deviations and change controls when required. • Performs duties following established company procedures and policies; performs other duties as assigned. Verification of proper gowning by all personnel in all areas of Production. Verification of environmental monitoring activities including plating, Lighthouse and personnel monitoring. Generation of deviations, issuance of CAPAs, Change Controls in response to observations Follow up with Quality Assurance Management on quality issue tracking and trending activities also include batch record review, batch release, visual inspection and any other activity assigned by Quality Assurance management. Oversee all Quality aspects on the floor Product label review and approval Participate in regulatory audits Performs or assists process owners with root cause analysis Prepares and monitors Quality Metrics and KPI’s Performs duties in accordance with established company procedures and policies; performs other duties as assigned.

• 3-5 years of progressive experience in cGMP quality operations and FDA regulations, a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment, or equivalent technical experience. • BS in the Scientific field preferred • Three-plus years of experience with aseptic drug product manufacturing is required. • A fundamental, working knowledge of safety, quality systems, and quality assurance concepts are required, including the application of current Good Manufacturing Practices and Good Documentation Practices. • Strong familiarity with manufacturing processes, operations, automation, and equipment/facilities. • Ability to complete tasks with little direction or need for supervisory follow-up. • Strong written, verbal, and presentation communication skills. • Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and others must be able to learn additional software as required). • Ability to think creatively in confronting new issues and pursuing novel approaches to old problems. • Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards. • Work schedule flexibility.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

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