Manager Quality Control

Leading manufacturer of Generic Drugs seeks an experienced candidate for the position of Manager, Qual;ity Control.



  THIS POSITION IS BASED IN NORTH CAROLINA

JOB DESCRIPTION:

The Manager of QC Material & Product Testing position is primarily responsible for ensuring uninterrupted laboratory operations in the Quality Control group. This is accomplished through disposition of materials Responding to out-of-specification test results Utilizing laboratory investigations Identifying areas for process improvement and other functions in order to maintain a high-throughput laboratory environment.

 

JOB FUNCTIONS:
1. Manages a high volume / throughput laboratory for testing of in process, finished product, stability samples, validation samples in a timely and efficient manner.

2. Conducts laboratory disposition of materials, ensuring that laboratory documentation complies with regulatory guidelines.

3. Responds to out-of-specification test results in accordance with regulatory guidelines and quickly isolates material issues from testing issues.

4. Utilizes laboratory investigations, material investigations, and product investigations in test disposition decisions.

5. Seeks opportunities to improve laboratory operations through the use of new technology, organization structure, and process improvement.

6. Manages the functional administration of the department, e.g., SOPs, Laboratory Standards, Administrative Procedures.

7. Manages the career development of direct reports.

8. Manages the administration of employee training including required documentation for SOP training.

9. Other duties as assigned.

EDUCATION: 

BS in Chemistry with 8 years experience or an advanced degree with 5 years experience.

WORK EXPERIENCE:

Previous managerial experience in pharmaceutical or bulk chemistry industry required.

1. Working knowledge and expertise of analytical equipment, software, and laboratory procedures.

2. Thorough knowledge of cGMPs.

3. Thorough understanding of analytical techniques, e.g., LC, GC, spectroscopic techniques, wet chemistry, dissolution.

This position offers excellent salary, bonus, 401K, and benefits to the person that can bring these skills and make a difference. Please respond with a Word Attachment Document.