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. Jackson Healthcare is a family of highly specialized healthcare staffing, search, and technology companies. Our mission is to improve the delivery of patient care and the lives of everyone we touch. 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