Operations QA Tech Specialist

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

Overview

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We're always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.

This individual will have overall process compliance responsibilities with the ability to stop production when required. This individual will be responsible for learning USAN processes and procedures in order to maintain the highest levels of quality. They will be responsible for the line/room clearances of manufacturing and packaging, review of batch records and other quality documentation. They will provide direct support and guidance for quality inquiries. Supports the existing quality systems, including executing SOPs and data management activities. This individual will be an active member of the Quality team and will be required to take on other quality activities as needed.

Key Duties & 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 or 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.

Minimum Qualifications / Experience:

• 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 / Certifications:

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

EEO Statement:

We are an Equal Opportunity Employer and do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under the law.