Job Summary
Responsible for supervising the activities of MQA Specialists. Mitigates production floor issues. Ensures the schedule adherence of the AQL Testing and Retention Sample Inspection and accuracy of the associated paperwork. Ensures compliance of the manufacturing floor against the Manufacturing Batch Records and Standard Operating Procedures. Performs initial investigations as required to ensure product quality. Performs data gathering for the Annual Quality Product Reviews. Performs continuous improvements initiatives for the MQA group and makes recommendations.
Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
- Supervises daily activities of MQA Specialists. Assures that their job objectives are met on a timely basis.
- Performs and oversees the training of personnel. Effectively hires, develops, counsels, manages, and motivates staff. Writes and administers performance appraisals for department personnel.
- Assures Standard Operating Procedures (SOPs) define the steps necessary to complete tasks and make updates to MQA related SOPs.
- Completes and implements corrective / preventive actions as needed.
- Supports the APQRs for the facility by collecting, maintaining, trending, and analyzing MQA testing data.
- Assures execution of testing procedures to assess the physical quality characteristics of in-process/finished products and production/packaging processes.
- Ensures the schedule adherence of the AQL Testing and Retention Sample Inspection and accuracy of the associated paperwork.
- Addresses daily quality concerns and questions. Offers recommendations as required. Performs initial investigations as necessary.
- Troubleshoots manufacturing problems and quality issues alongside with Operations personnel to implement immediate corrective actions.
- Maintains knowledge of current GMPs and regulatory guidelines.
- Performs supplemental investigations/projects as required by management.
- Performs other tasks as required by management.
REQUIREMENTS
- Bachelor of Science degree or three (3) to five (5) years of equivalent education / progressive responsibility in support of pharmaceutical manufacturing preferred.
- A high-school diploma with previous related pharmaceutical experience
- A minimum of five (5) to ten (10) years of experience required
- Solid computer skills and excellent verbal and written communication skills required.
- Knowledge of cGMP, legal, and regulatory requirements governing manufacture of pharmaceutical products.
- Must be knowledgeable of quality testing methods, validation techniques, and physical testing methods/concepts.
- Must be able to understand and significantly interpret data utilizing analytical skills and practical experience in pharmaceutical application.
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.
