Job Summary
This important role is responsible for the management of the Manufacturing Quality Assurance departmental activities, which include managing the evaluation, implementation, execution and follow-up on quality systems in support of GMP compliance and release of finished product. Responsible for quality assurance oversight of the manufacturing and packaging processes and procedures; which allow for the accurate and timely release of manufacturing and packaging batch record documentation. The MQA Manager provides final review of investigations to ensure product quality, and appropriate implementation of corrective action in a timely manner to prevent recurrence. Performs analysis on quality and manufacturing indicating data and recommends actions for compliance and process improvement.
• Salary Range: $135.000 - $165,000
• Position is eligible to participate in a bonus plan with a target of 14% of the base salary
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.
Responsibilities
POSITION RESPONSIBILTIES
- Directly oversees Manager, MQA and leads team of MQA Supervisors and Specialists in daily integration of monitoring, auditing and review of manufacturing operations.
- Provides compliance direction to all functional groups within manufacturing, Packaging, 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, in-process quality check and batch record review.
- 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. Supports Quality in inspections for the Manufacturing facility. 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.
POSITION REQUIREMENTS
- Bachelor of Science Degree required.
- Minimum of 8 years of relevant experience in progressively more challenging leadership roles in quality to support pharmaceutical manufacturing processes.
- Extensive knowledge of legal and regulatory requirements governing the manufacture of pharmaceutical products.
- Technical knowledge of all manufacturing related processes, process and equipment validation preferred.
- Must be able to understand and interpret data utilizing analytical skills and practical experience in pharmaceutical application.
- Demonstrate leadership and decision-making qualities.
- Computer skills..
- Excellent verbal and written communication skills.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
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.
