Operations Quality Assurance Technical Specialist

Parker Staffing, LLC.; Belle Brook Estates (TN); Presencial; USD 34 000 - 41 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Paid time off

Medical, Dental and Vision Insurance

401(k) plans

Full Benefits Summary Available Upon 


Resumo da oferta

Parker Staffing, LLC. is seeking an Operations Quality Assurance Technical Specialist for our client’s Bristol, TN site. The role supports production compliance, batch record reviews, and QA activities with authority to stop production if needed.

Qualifications include 3+ years in quality roles, GMP/GLP knowledge, and strong communication. This is a direct hire, onsite opportunity offering a competitive pay rate and comprehensive benefits.

Qualificações

• 3+ years of experience in a Quality related position with GMP/GLP
• 2+ years of processing experience
• Strong interpersonal communication skills
• Ability to work across three shifts when necessary

Responsabilidades

• Performs line clearances to ensure documents, equipment and processing areas are ready for processing and changeovers
• Conduct routine audits of manufacturing processes, equipment, and documentation
• Monitor production activities to ensure adherence to procedures
• Verify the accuracy of manufacturing batch records and final sign offs
• Review and approve packaging batch header sheets and labeling
• Ensure SOPs and cGMP compliance on the shop floor
• Collect, analyze and trend quality data for improvements
• Collaborate with departments to implement quality enhancements
• Represent QA on shift to resolve issues
• Utilize SAP, QMS and training programs for change controls and CAPAs
• Write or update SOPs and policies
• Perform other duties as assigned

Conhecimentos

Quality assurance

Analytical skills

Communication

Problem solving

Formação académica

Bachelor's degree in scientific field

Ferramentas

SAP

QMS

Microsoft Excel

Descrição da oferta de emprego

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

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.