Operations Quality Assurance Technical Specialist

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 and Experience

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.

Qualifications

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.

Education

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

Benefits offered by our client:

Paid time off for vacation, sick days and holidays

Medical, Dental and Vision Insurance

401(k) plans

Full Benefits Summary Available Upon Interview

Parker Staffing offers all levels of Administrative, Customer Service, Call Center, Sales, and Human Resources job opportunities in the Seattle and Bellevue metro area and other large cities throughout the Nation. Parker Staffing has served as the staffing agency of choice for thousands for over four decades. Visit our employment opportunities page at http://www.parkerstaffing.com to review our full offering of temp, temp-to-hire, and direct hire job openings!

Smoking/vaping and the use of tobacco products are prohibited on all Company premises, including indoor and outdoor areas, parking lots, and Company-owned vehicles.

As part of our employment process, candidates who received a conditional offer may be required to undergo pre-employment drug testing.

Parker Staffing is an Equal Opportunity Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status.