Operations Quality Assurance Technical Specialist


Job ID: 25850
Pay Rate: $25.00 – $30.00
Location: Onsite – Bristol, TN
Employment Type: Direct Hire  

Make an Impact Where Quality Meets Purpose!

Join our clients team – a leader in American-made, life-saving pharmaceuticals and the only authorized U.S. manufacturer of Amoxicillin and Amoxicillin Clavulanate – two of the most widely prescribed antibiotics in the nation.
Located in Bristol, Tennessee, our client operates a world-class, 394,000-square-foot manufacturing facility recognized as critical infrastructure by the Department of Homeland Security. Our client plays an essential role in strengthening America's domestic pharmaceutical supply chain and ensuring access to medications millions of people rely on.

We're looking for a detail-oriented, quality-driven professional to join our Quality team!
In this hands-on role, you'll help uphold the highest standards of pharmaceutical manufacturing through production compliance oversight, manufacturing and packaging clearances, batch record reviews, and quality assurance activities. You'll have the authority to stop production when necessary, ensuring every product meets rigorous quality and safety standards.

This is more than a job – it's an opportunity to make a meaningful difference in American healthcare. If you're passionate about quality, take pride in doing things right, and want your work to contribute to something bigger, we'd love to connect with you!

Essential Duties and Responsibilities  

• Performs line clearances to ensure that documents, equipment and processing areas are ready for processing and/or changeovers between products
• Conduct routine audits of manufacturing processes, equipment, and documentation, including logbooks
• Monitor production activities to ensure adherence to established procedures
• Verify the accuracy and completion of manufacturing batch records throughout the manufacturing process. This will also encompass final batch record sign off/approvals, including creating Usage Decision Memos, CPSIA certificates.
• Review and approve packaging batch header sheets/printed labeling prior to Manufacturing use
• Ensuring compliance that Standard Operating Procedures (SOPs) and cGMPs are followed within Operations
• Collect, analyze, and trend quality data and metrics to identify recurring issues and opportunities for improvement
• Collaborating with other departments to identify areas for improvement and implement quality enhancement initiatives
• Representing/Acting as a QA representative on shift to make decisions and resolve issues
• Utilize and support the Quality Management Systems, SAP, and training programs which include logging/tracking/issuing change controls and procedures, temporary changes, CAPAs, risk assessments, investigations, etc.
• Write, review, or implement new standard operating procedures and policies, as necessary
• Perform other duties as assigned  

• Knowledge of change controls, CAPAs, investigations, and quality risk management
• Experience in regulated manufacturing environments, preferably in a pharmaceutical environment
• Excellent knowledge of cGMPs, Good Documentation practices and FDA Regulations
• Must possess exceptional oral and written communication as well as have collegial interpersonal skills.
• Possess strong analytical, problem-solving, and organizational skills
• Proficiency with Microsoft Office applications, particularly Excel. SAP and QMS experience preferred
• ASQ Certified Quality Improvement Associate (CQIA), Certified Quality Technician (CQT), or similar certification preferred.

• 3+ years of experience in a Quality related position and knowledge of current GMP and GLP.
• 2+ years of processing experience
• Strong interpersonal communication skills required – verbal, written and presentation.
• Ability to work in a cross-functional team environment across three shifts when necessary.  

• Bachelor’s degree in a Scientific related field preferred with at least 3 years of pharmaceutical experience 

• Paid time off for vacation, sick days and holidays 
• Medical, Dental and Vision Insurance
• 401(k) plans
• Full Benefits Summary Available Upon Interview