Supervise the work of laboratory personnel engaged in performing routine finished product testing & stability testing, including planning laboratory work, evaluating work performed and handling procedural and technical laboratory problems. Execute according to high standards of quality at the lab through managing and continuously improving the effectiveness of laboratory quality processes and systems 

Job Duties & Responsibilities

• Supervise the testing of bulk release, finished product and stability testing 
• Manage and supervise QC laboratory personnel with varying levels of experience, assigning the work schedule and ensure assigned tasks are performed.
• Review of test results for accuracy and proper documentation.
• Review of specifications and STMs for in process and finished products.
• Write OOS investigations, including finding root cause and corrective/preventive actions.
• Supervise lab processes, including timely management of investigations, CAPA implementation to ensure sustainable compliance
• Review of SOPs, lab related investigations, stability failure notifications, COAs, and compilation of stability related data. Responsible for timely release of in-process, finished product release COA’s
• Monitor and report the trends in bulk, finished products, and stability samples to QC/QA Management
• Review of IQ, OQ, and PQ for new instruments, protocols/reports
• Responsible for coordinating with other departments like warehouse, QA, Maintenance, purchase department, R&D in day to day activity for better operational requirements and to follow the cGMP requirements.
• Responsible for the coordination of sample management, not limited to in-process, finished product and stability samples.
• Monitor Quality Control, Safety and cGMP practices to assure compliance with internal and external regulations.
• Perform other related duties as assigned to meet departmental and Company objectives.

Management Responsibility 

• Manage group of scientists.

Reports to

• Associate Director / Director

Knowledge & Skills 

• Ability to maintain integrity and honesty at all times
• Ability to communicate and lead with transparency
• Accountable for performance and results of department
• Ability to assume additional responsibilities on own initiative.

Experience & Education

• Requires minimum BA/BS in Biochemistry, Chemistry or related field with 10-15 years’ experience in the biotech or pharmaceutical industry. Management experience in Quality Control required MS/MA.

Physical Requirements/Working Environment

• Regular Laboratory environment with lab coats, safety glasses, 4-6hrs/day of standing while performing chemical test and able to stand for 4-6hrs/day.

Travel 

• No Travel requirement.

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.