QA Manager

• Provides compliance direction to all functional groups within manufacturing, MQA and other quality support groups.

• Evaluates existing quality systems at the facility. Recommends, develops, secures approval of, implements and follows up on new and existing quality systems.
• Utilizes and updates systems in place to perform per the current processing requirements.
• Designs, implements and monitors performance of daily quality assurance audit function and in-process quality check.
• Troubleshoots manufacturing and quality issues. Forms corrective action plans to resolve issues.
• Troubleshoots and monitors performance of quality assurance personnel in the following functions:
• Reviewing production deviations and environmental excursions. Assisting in evaluation of action plans.
• Review of protocols for process and equipment enhancements.
• Conducting process audits of the manufacturing areas.
• Issuing batch records.
• Performance of labeling and functionality checks.
• Execution of the inspection program, including qualifications, AQL executions and defect categorizations.
• Auditing completed batch records prior to product release.
• Performing daily quality oversight of production with focus on critical process steps.
• Trending/analyzing process data.
• Acts as FDA liaison for the facility.
• Coordinates investigation and documentation requests and serves as QA representation during the investigation.
• Effectively hires, develops, coaches, manages and motivates staff.
• Supports and implements HR policies and procedures. Writes and administers performance appraisals.
• Identifies and implements needed organizational changes to meet operational plans and assure the attainment of QA goals and objectives.
• Develops and administers financial budget for the department.
• Manages work in process for the facility to facilitate timely release of finished product which meets Fresenius Kabi and GMP requirements.
• Releases product, which has demonstrated compliance to Fresenius Kabi and GMP requirements through review of manufacturing and testing documentation. Assures that product not meeting specifications is properly investigated prior to release and/or rejection.
• Advises the Director, QA on matters relating to daily operations. Makes/implements recommendations for improvement.
• Prepares reports as required.
• Performs supplemental investigations/projects as required by Senior QA and Operations management.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.