QC Supervisor Raw Materials & Incoming Components

POSITION TITLE:

QC Supervisor – Raw Materials & Incoming Components

REPORTS TO:

QC Lab Manager or Associate Director, QC

LOCATION:

Richmond, VA POSITION SUMMARY Manages the sampling, analytical, microbiological, and physical testing of raw materials, packaging components, bulk, intermediate, finished product, and stability samples within established lead times using Lean Lab principles. Ensures scientists and inspectors are adequately trained and execute testing according to Fareva SOPs and federal regulatory bodies. Ensures adequate and appropriate use, calibration, and maintenance of laboratory instruments. Oversees daily operations, conducts periodic performance reviews, and manages staffing needs.

Mentors, coaches, and disciplines personnel to achieve department goals and maintain compliance standards.

POSITION RESPONSIBILITIES Supervision of Testing Program Plans, organizes, and supervises the sampling and testing program for raw materials, packaging components, release, stability, validation, non-routine, and special project samples.

Oversees scientists/inspectors and coordinates routine tasks, priorities, and schedules.

Ensures specifications and analytical methods exist and that suitable, qualified, and calibrated equipment is available.

Reviews and approves laboratory records, maintaining good order of testing documentation.

Supports stability and validation schedules.

Coordinates laboratory investigations for deviations; initiates and follows up on corrective actions (CAPAs).General Operations & Administration Recruits, hires, and trains analysts, inspectors, and laboratory helpers.

Reviews subordinate performance against established goals and key result areas.

Assists in annual budget formulation; controls lab spending and purchases capital equipment per schedule.

Performs other related duties assigned by the QC Associate Director or QC Lab Manager.

Laboratory & Technical Support Designs, develops, and evaluates plans for projects, studies, investigations, and reviews.

Takes ownership of planning and execution needed to achieve routine goals, consulting management on long-range planning and priority conflicts.

SOPs & Compliance Makes independent contributions to new laboratory technologies, method revisions, and SOP updates to maintain regulatory compliance.

Training & Mentorship Trains and mentors junior scientists/inspectors on existing and new procedures, techniques, and regulatory guidelines.

Shares technical expertise to assist team members in solving complex analytical problems.

ORGANIZATIONAL RELATIONSHIPS Quality Operations Management:
Discuss analytical issues, cGMP compliance, and corrective actions.

Quality Operations Peers:
Consult on workload priorities, methods, SOP interpretations, and cross-functional support.

Junior Quality Staff:
Direct supervision, training, mentoring, and record reviews.

Production Scheduler / Master Scheduler:
Align testing timelines with plant operational needs.

External Vendors:
Coordinate equipment procurement, servicing, and lab supplies.

SUPERVISION Directly manages approximately 8–12 full-time and contract employees (scientists, inspectors, and lab helpers) depending on workload. Works independently of immediate supervision with periodic alignment meetings with next-level management.

REQUIREMENTS

Education & Experience:

BS Degree in Biology, Chemistry, Microbiology, Biochemistry, or relevant science discipline + 8 years of relevant Quality experience (preferably bio/pharmaceutical).MS Degree in Biology, Chemistry, Microbiology, Biochemistry, or relevant science discipline + 6 years of relevant Quality experience (preferably bio/pharmaceutical).Technical Skills & Abilities:

Strong practical and theoretical knowledge of FDA compliance guidelines, cGMP, Fareva SOPs, and USP/NF/ACS test procedures.

Experience managing both raw material wet chemistry/analytical testing and physical incoming component inspection programs.

Proficient in interpreting/documenting results via Quality management systems; strong experience with LIMS preferred.

Proven ability to troubleshoot analytical methods of moderate complexity and manage Lean Lab scheduling.

Strong leadership and cross-functional communication skills to drive projects and process improvements.