QC Micro Lab Supervisor

QC Supervisor - Micro Lab

Fareva is currently seeking an experiencedQC Supervisor - Micro Lab to join our team in Richmond, VA.

Who we are:

Fareva is a leading contract manufacturer of pharmaceutical and personal care products. Located at intersection of Darbytown Road and Laburnum Avenue in Eastern Henrico County. Employs 600 full time employees. Comfortable climate controlled facility covering over 745,000 square feet.

About the role:

Manages the sampling and microbiological testing of raw material, bulk, intermediate, finished product and stability samples within established lead times using Lean Lab principles. Ensures scientists/inspectors are adequately trained and execute testing according to Fareva SOPs and federal regulatory bodies. Ensures adequate and appropriate use, calibration and maintenance of instruments. Oversees and manages daily activities of personnel, periodic review of personnel and requests additional personnel as needed. Mentors, coaches and disciplines personnel to achieve results.

What you'll do:

Supervision of Testing Program

• Plans, organizes and supervises the testing program for release, stability, verification, validation, non-routine and special project samples.
• Oversees scientists/inspectors and assists in the coordination the assignment of routine tasks and priorities for testing to be executed.
• Ensures that specifications and analytical methods exist for sample testing and that suitable equipment and instruments are available, working properly, serviced, qualified and calibrated.
• Maintains in good order, records pertaining to testing.
• Supports the stability and validation programs as per schedule.
• Coordinates the activities related to laboratory investigations for deviations, initiates and follows-up on the implementation of corrective actions.
• Reviews and approves laboratory records.

General Activities

• Recruits and trains analysts and laboratory helpers to carry out the functions of QC.
• Reviews performance of subordinates periodically in regard to the achievement of goals, objectives and key result areas.
• Assists in developing annual budgets and updates for the approval of the QC Associate Director or QC Lab Manager.
• Purchases capital equipment per schedule and controls laboratory spending in respect of budgetary requirements.
• Performs any other related duties as assigned by the QC Associate Director or QC Lab Manager.

Laboratory Support

• Designs, develops and evaluates plans for projects, studies, investigations, and reviews.
• Completely responsible for planning and execution of all tasks needed to achieve routine goals.
• Seeks advice on planning from management when there are priority conflicts.
• Considers and consults with management in area of long-range planning for further development of the function.

SOPs and Administration

Able to make independent contributions to the development of new technologies, developing and revising methods and procedures to assure compliance with applicable regulations; carries out technical and administrative duties as assigned.

Trains and Mentors

• Trains more junior scientists/inspectors in new and existing procedures, techniques and governmental regulations as directed by management.
• Mentors scientists/inspectors by providing technical knowledge and support in resolving technical problems.

Education and experience

• BS degree in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline - 8 years of relevant Quality experience preferably in the bio/pharmaceutical industry.
• MS degree in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline - 6 years of relevant Quality experience preferably in the bio/pharmaceutical industry.
• Strong background in relevant analytical methods and techniques and ability to supervise/coach people.
• Mentors/trains in routine procedures demonstrating expertise.

Skills and abilities:

• Extensive practical and solid theoretical knowledge of applicable compliance guidelines of the FDA or other regulatory bodies; test procedures such as USP, NF and ASC; and relevant Fareva SOPs.
• In addition to high technical competence, understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development. Continues to expand breadth of technical expertise.
• Ability to interpret and document test results according to standard operating procedures using all standard Quality systems; strong background using LIMS is desirable.
• Demonstrated ability to independently develop, document and troubleshoot methods of moderate complexity.
• Ability to review workload and determine most efficient and effective testing plan schedule.
• Ability to lead teams comprised of immediate group members or to work cross functionally, if necessary
• Ability to provide equipment and procedure training and to share technical expertise with less experienced peers/scientists/inspectors to solve problems.
• Can independently design and carry out a series of studies/reviews to solve a problem or evaluate a process/procedure. Solutions may involve the development of new techniques and procedures. Uses the literature and peers/scientists/inspectors as resources in order to solve problems.

What we offer:

Competitive salaries, comprehensive health/vision/dental insurance, company paid short term disability, company paid life and accidental death insurance (after 30 day waiting period), 401(k) plan match of 4.5% with immediate vesting, generous employee referral program, paid vacation annually, 12 paid holidays annually, onsite cafeteria, job advancement opportunities. Manufacturing employees also receive company paid work shoes, uniforms and prescription safety eyeglasses.