Operations QA Tech Specialist

Jackson Healthcare•Bristol, TN

5d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

SAP and QMS experience preferred.
ASQ Certified Quality Improvement Associate (CQIA), Certified Quality Technician (CQT), or similar certification preferred.
Bachelor’s degree in a Scientific related field preferred with at least 3 years of pharmaceutical experience.

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.