1) Supervises daily activities of MQA Specialist. Assures job objectives are met on a timely basis.

2) Updates and procures approval of job descriptions for department personnel. Performs and oversees the training of personnel. Effectively hires, develops, counsels, manages and motivates staff. Writes and administers performance appraisals for department personnel.

3) Assures standard operating procedures (SOPs) define the steps necessary to complete tasks, etc. Writes reviews and updates SOPs.

4) Assures timely execution of batch record certification function. Follows up with department management to ensure corrective action is implemented.

5) Supports Statistical Process Control programs for the facility. Collects, maintains, trends and analyzes data. Trains Operations and QC personnel as necessary.

6) Assures execution of monitoring and testing procedures to assess the physical quality characteristics of in-process/finished products, environmental parameters, and production/packaging processes.

7) Performs analysis on monthly quality indicating reports generated by MQA Specialists. Makes recommendations for improvement. Follows up on corrective action with departmental management.

8) Develops systems to facilitate timely finished product disposition. Performs investigations as required. Follows up to ensure corrective action is implemented. Initiates/supports management meetings/projects to facilitate timely product disposition.

9) Addresses daily quality concerns and questions. Offers recommendations as required. Performs investigations as necessary.

10) Troubleshoots manufacturing problems and quality issues. Works with Operations personnel to investigate, collect and analyze data for, resolve and implement corrective action. Contacts supplier and/or outside laboratory for investigational support.

11) Maintains knowledge of current GMPs and regulatory guidelines.

12) Performs supplemental investigations/projects as required by management.

13) Reviews incident reports/investigations and determines impact on product disposition.

All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

JOB REQUIREMENTS

* Bachelor of Science Degree strongly preferred; equivalent of education and relevant work experience will be considered.

* At least 5 years experience in a quality role; ideally in support of pharmaceutical manufacturing. Supervisory experience preferred.

* Knowledge of legal and regulatory requirements governing the manufacture of pharmaceutical products.

* Must be knowledgeable of quality control testing methods, validation techniques, and physical testing methods/concepts.

* Must be able to understand the significantly interpret data utilizing analytical skills and practical experience in pharmaceutical application.

* Proficient in Microsoft Office.

Excellent verbal and written communication skills required.

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