Category: Scientific & Clinical
Quality Control Supervisor
The Quality Control and Lab Supervisor is committed to producing quality, safe and legal products that meet or exceed our customer’s specifications. Duties include but are not limited to supervising and conducting the physical and chemical analyses of raw materials, in-process and finished products. Acts for the Quality Manager in their absence or when responsibilities are delegated. Responsible for food and drug products meeting all applicable legislative and regulatory requirements for release to customers. Ensures all related cGMP Food Safety and Quality System SOP's pertaining to, safety, operations, and personal conduct is followed. Provides inventory and production planning support through assignment and tracking of lots including label control. Directs the work of three laboratory analysts and quality inspector(s).
What You Need To Be Successful
- Minimum of five years’ lab experience in a Food and/or Pharmaceutical manufacturing environment with at least 2 years of supervisory experience
- BS degree preferred, AS degree in Chemistry
- SQF Practitioner with HACCP training preferred
- Working knowledge of regulatory requirements for active bulk pharmaceuticals (API)
- Working knowledge of both wet chemistry and lab instrumentation including AA, pH, Sieve Analysis
- Good problem solving skills and ability to act independently and on one’s own initiative
- Good interpersonal skills
- Must have experience involving USP/EP testing requirements and cGMP and cGLP regulations
- Written and oral communication skills
- Good mathematical abilities and proficient in Microsoft Word and Excel
- Develops written test procedures as per compendia methods.
- Trains Analysts on approved test procedures and provides written documentation of training. Provides annual certification of Analysts qualifications on compendia methods.
- Verifies that analysts are performing tests as per written procedures.
- Reviews current test procedures for accuracy.
- Coordinates analyses on Raw Materials, in-process and finished products in an efficient and timely manner.
- Investigates out of specification laboratory results and provides written documentation to Quality Manager.
- Coordinates outside laboratory testing and reports/ results.
- Coordinates laboratory work schedule with production and shipping to ensure on-time product release to meet delivery schedules.
- Participates in production planning through assignment and management of product lots for KCl, KCl blends and caustic pellets. Manages caustic pellet inventory.
- Maintains label control system and oversees printing and issuing of all labels.
- Maintains customer specifications and ensures in-process testing aligns with specifications when customer orders are produced.
- Creates and distributes all Certificates of Analysis to customers.
- Supervises QC inspection of finished product.
- Trends test data and reports potential problems to Quality Management.
- Maintains Good Housekeeping practices in the laboratory.
- Maintains and performs laboratory calibration schedule
- Maintains and performs stability schedule.
- Works with Quality Manager to maintain laboratory supplies within annual operating budget.
- Implements and or maintains GFSI Global Food Safety Certification (SQF)
- Follows all GMP rules and help coach others to comply with GMP rules as necessary
- Performs other duties as assigned.
Duration: Direct Hire
Location: Berkeley Heights, NJ