Quality Control Manager

Granules•Chantilly, VA

1d•Onsite

About The Position

The Quality Control Manager supervises laboratory personnel engaged in routine finished product and stability testing. This includes planning laboratory work, evaluating work performed, and handling procedural and technical laboratory problems. The role is responsible for executing according to high standards of quality in the lab through managing and continuously improving the effectiveness of laboratory quality processes and systems.

Requirements

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.
Minimum BA/BS in Biochemistry, Chemistry or related field.
10-15 years’ experience in the biotech or pharmaceutical industry.
Management experience in Quality Control required.

Nice To Haves

MS/MA

Responsibilities

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.
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.
Manage group of scientists.