QA Operations Tech – GMP Compliance & Process Excellence

USAntibiotics, LLC; Bristol (TN); On-site; USD 75,000 - 110,000; Full time

Job summary

USAntibiotics, LLC is seeking a QA professional in Bristol, TN to oversee line clearances, batch record review, and support quality systems in a regulated pharmaceutical manufacturing environment.

The role requires strong knowledge of cGMP, GMP documentation, CAPAs, and investigations, with cross-functional collaboration across shifts to ensure product quality and regulatory compliance.

Qualifications

• 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.

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.
• Review and approve packaging batch header sheets/printed labeling prior to Manufacturing use.
• Ensuring compliance that 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.

Skills

Change controls CAPAs investigations

cGMPs FDA Regulations

Communication skills

Analytical problem solving

Office Excel SAP QMS experience

CQIA/CQT certification

Education

Bachelor’s degree in scientific field

Tools

SAP

QMS

Job description

USAntibiotics, LLC is seeking a QA professional in Bristol, TN to oversee line clearances, batch record review, and support quality systems in a regulated pharmaceutical manufacturing environment.

The role requires strong knowledge of cGMP, GMP documentation, CAPAs, and investigations, with cross-functional collaboration across shifts to ensure product quality and regulatory compliance.