Quality Control Manager

Granules Pharmaceuticals Inc.; Chantilly (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

A biotech company based in Chantilly, Virginia, is seeking an experienced Quality Control Manager to supervise the laboratory activities related to routine finished product testing and stability testing. The ideal candidate will have a minimum of a Bachelor's degree in Biochemistry or Chemistry, with 10-15 years of relevant experience and proven management skills in quality control. Responsibilities include supervising laboratory personnel, ensuring compliance with cGMP practices, and coordinating with other departments.

Qualifications

• A minimum of BA/BS in Biochemistry, Chemistry or related field is required.
• Must have 10-15 years of experience in the biotech or pharmaceutical industry.
• Management experience in Quality Control is required.

Responsibilities

• Supervise the testing of bulk release, finished products, and stability testing.
• Manage QC laboratory personnel, assigning work schedules.
• Review test results for accuracy.
• Write investigations including root cause and corrective actions.
• Coordinate with other departments for operational needs.

Skills

Integrity and honesty

Communication and leadership

Accountability for performance

Initiative for additional responsibilities

Education

BA/BS in Biochemistry, Chemistry or related field

10-15 years’ experience in biotech or pharmaceutical industry

Management experience in Quality Control

Job description

Description

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

Requirements

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.