Quality Control (QC) Supply Chain Supervisor

Quality Control (QC) Supply Chain Supervisor

POSITION SUMMARY: The QC Supply Chain Senior Supervisor is responsible and accountable for the oversight of sample receiving, NIR testing and sample delegation for in-house and outside contract laboratory (OCL) testing. Manages the coordination of analyses performed by OCL and generation of certificates of analysis. Ensures the accurate and timely submission of samples and release of materials and products. Maintains effective communication with other departments to achieve company goals and objectives.

FLSA STATUS: Exempt

RESPONSIBILITIES – Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job

• Knowledgeable of the applicable Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (GMPs) and maintains knowledge base on an ongoing, timely basis as procedural changes occur without relying on management intervention or direction.
• Oversees sample receiving, delegation and sample submission for analyses by the different labs (in-house and OCL) to ensure that test requirements are accurately assigned, and due dates are met. Corresponds with OCL representatives for rush analyses and other inquiries.
• Develops procedures and work instructions related to laboratory supply chain operations.
• Manages the sample retention program.  Becomes proficient using the Laboratory Information Management System (LIMS).
• Implements, tracks, measures, and reports on key performance indicators and objectives.
• Identifies cost savings and lead time opportunities with outside contract laboratories.
• Support and participate in internal audits, regulatory audits, and certification audits.
• Supports lab ISO or certification initiatives and oversees implementation in the Supply Chain group.
• Collaborating on new product development or reformulations regarding test methods.
• Ensures the accurate reporting of data for all in-house and OCL analyses of products (raw materials, intermediary materials, finished products, stability samples, supplier samples, investigational and R&D samples), including but not limited to correct test methods being performed, correct analytes and correct units being reported.
• Works with LIMS personnel when issues associated with sample receiving, specifications (raw materials and finished products) and batch release are encountered.
• Demonstrates attention to detail in all aspects of lab procedures, follows department procedures and company policies and completes all paperwork accurately, neatly and in compliance with good documentation practices (GDPs).
• Oversees and develops training of the QC Supply Chain personnel (sample receiving and data group personnel) to ensure that employees are trained in applicable procedures and that required training is completed in a timely manner. Ensures training is reasonably continuous, timely and conducted before employees begin new tasks.
• Ensures that performance appraisals for direct reports are conducted in a thorough and timely manner. Conducts periodic check-ins with staff to provide performance and behavior feedback, including performance versus expectations and goals, behaviors, leadership potential and seeks the same for self.
• Reviews QC documents, performs a thorough investigation of out-of-specification (OOS) results reported by OCLs including communicating with the OCLs when investigational information is required. Assists with root cause analysis when requested.
• Reviews test results and works with the lab management to resolve testing problems/issues and ensures that all laboratory data is documented in compliance with regulatory and industry standards.
• Actively participates in required training and development programs as suit one’s needs and supports colleagues, trainers and management as appropriate with these efforts.
• Manages purchase orders for OCL testing and for QC lab supplies. Responsible for inventory management.
• Actively participates in process improvement initiatives aiming for Right-First-Time (RFT) on documentation and OOS/Deviation/NCM reduction in collaboration with Quality management.
• Responsible for escalation of OCL OOS investigations and assists with developing and implementing long-term strategies and continuous improvements.
• Demonstrates initiative and job knowledge by suggesting ideas and discovering new and better ways to accomplish goals. Finds innovative, well thought-out and science-based solutions to problems.
• Works with QC Laboratory Management in timely completion of department OKRs.
• Builds and leads a highly performing team, secures the best talent, develops and strengthens the QC Supply Chain staff, provides ongoing coaching and feedback.
• Contributes to strategies related to QC laboratories which align with compliance and business objectives as well as the overall company vision and goals.
• Participates in personnel actions.

What You Need:

• Bachelor’s degree (BS/BA) in chemistry, biochemistry, microbiology or related science discipline is required. An advanced degree is a plus.
• Prior supervisory and/or managerial experience in laboratory compliance in a cGMP or ISO laboratory environment is required.
• Prior experience in testing and release of chemicals/pharmaceuticals/dietary supplement products is desirable.

Physical Demands:

• Must be able to work in a stationary position for long periods of time as well as move about unassisted. Must be able to hear and converse with supervisors and other employees. Must be able to read large volumes of printed material. Must be able to work in a moderate noise level environment.

What We Offer:

A little bit more about us:

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER

Thorne values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.