QC Lab Operations Lead

Job Description

Job Description

Job Summary:

The QC Lab Operations Lead provides daily operational leadership and hands-on coordination for the QC Lab Sampling & Login team within a cGMP nutraceutical manufacturing environment. This role is responsible for ensuring all incoming raw materials, work-in-progress (WIP), packaging components, and finished goods are accurately sampled, logged, labeled, and submitted for testing in a timely and compliant manner.

The Lead serves as the primary floor-level resource for sampling operations, ensuring adherence to aseptic techniques, GMP documentation practices, safety standards, and laboratory organization requirements. This role also supports employee training, workflow prioritization, and continuous improvement efforts to maintain audit readiness and operational efficiency.

Job Duties and Responsibilities:

Daily Sampling & Login Operations

• Coordinate and oversee daily sampling and sample login activities for raw materials, WIP, packaging components, and finished products.
• Ensure all samples are collected, labeled, documented, and entered into the laboratory information or ERP system accurately and within established timelines.
• Verify sample integrity, traceability, and chain-of-custody documentation prior to laboratory submission.
• Ensure same-day processing of incoming sample requests whenever operationally feasible.
• Review documentation for completeness, accuracy, and compliance with GMP requirements.
• Support prioritization of urgent production or release-related testing requests.

Sampling Booth & Laboratory Organization

• Maintain ownership and accountability for sampling booths, staging areas, and sample login workspaces.
• Ensure sampling rooms remain clean, sanitized, organized, and inspection-ready at all times.
• Coordinate routine cleaning, sanitation, and supply restocking activities during operational downtime.
• Monitor inventory levels for sampling supplies, PPE, labels, cleaning materials, and laboratory consumables.
• Ensure proper handling and disposal of sampled materials and waste according to company procedures.

Team Leadership & Training

• Provide daily direction, coaching, and floor support to QC Sampling Technicians and temporary staff.
• Train new employees on GMP documentation, sampling techniques, aseptic practices, material handling, and safety procedures.
• Serve as the subject matter expert (SME) for sampling processes and material handling requirements across a diverse ingredient portfolio.
• Reinforce compliance expectations and promote accountability, attention to detail, and teamwork.
• Assist management with onboarding, cross-training, and performance feedback for sampling personnel.

Compliance & Quality Systems

• Ensure all sampling activities comply with cGMP regulations, SOPs, safety standards, and quality system requirements.
• Support internal audits, customer audits, and regulatory inspections as needed.
• Identify and escalate deviations, discrepancies, contamination risks, or documentation errors to QC management.
• Assist with investigations, CAPAs, and process improvement initiatives related to sampling operations.
• Maintain accurate records in accordance with Good Documentation Practices (GDP).

Operational Coordination & Communication

• Partner closely with the QC Lab Manager to communicate daily workload status, staffing needs, bottlenecks, and operational concerns.
• Assist in balancing staffing resources with daily production and incoming material volumes.
• Collaborate cross-functionally with Warehouse, Production, Quality Assurance, and Supply Chain teams to ensure timely sample flow and testing support.
• Recommend process improvements that enhance efficiency, organization, compliance, or turnaround times.

Qualifications & Experience

• High school diploma or equivalent required; Associate degree in science or related field preferred.
• 2+ years of experience in a GMP-regulated manufacturing, laboratory, food, pharmaceutical, or nutraceutical environment preferred.
• Prior experience with material sampling, inventory handling, laboratory support, or quality operations strongly preferred.
• Demonstrated leadership or peer-lead experience in a production or laboratory setting preferred.
• Familiarity with cGMP requirements, aseptic techniques, and Good Documentation Practices (GDP).
• Experience working with ERP, inventory, or laboratory information systems preferred.

Knowledge, Skills & Competencies

• Strong organizational and time management skills with the ability to prioritize multiple tasks in a fast-paced environment.
• Excellent attention to detail and documentation accuracy.
• Strong communication and interpersonal skills.
• Ability to lead by example and maintain accountability within the team.
• Ability to identify process inefficiencies and support continuous improvement efforts.
• Working knowledge of laboratory terminology and material handling practices.
• Ability to adapt to changing priorities and operational demands.

Physical Requirements & Work Environment

• Ability to stand and walk for extended periods throughout the workday.
• Ability to lift, move, and handle materials up to 50 lbs. occasionally.
• Frequent bending, reaching, pushing, pulling, and repetitive hand movements.
• Required use of PPE including gloves, hair nets, beard covers, lab coats, safety glasses, and respirators where applicable.
• Work performed in laboratory, warehouse, and manufacturing environments with exposure to powders, dust, allergens, cleaning chemicals, and varying temperatures.