Quality Control Supervisor

A collective energy and ambition. A place where you can make a real difference.

• →Timely review of raw material, bulk and finished product analysis reports. Escalate laboratory or product quality issues that may impact product quality, consumer safety, regulatory compliance, or batch release.
• →Manage performance, attendance, scheduling, succession planning, and employee development. Cross train team to maintain adequate laboratory coverage and business continuity.
• →Provide safety training and lead the QC laboratory Job Safety Analysis program; ensure team compliance and personally comply with all safety policies and procedures.
• →Manage chemicals and supplies against the laboratory budget, maintain laboratory equipment service contracts, and develop laboratory procedures as needed.
• →Establish and track KPI’s for laboratory trends and continuous improvement.
• →Ensure laboratory investigations are scientifically sound, adequately documented, and identify assignable root causes that are supported by evidence.
• →Provide leadership and oversight to ensure QC laboratory compliance with cGMP requirements, FDA regulations, and site Quality Systems, while maintaining a continuous state of audit and inspection readiness.
• →Oversee analytical support for process validation and ensure laboratory equipment qualification and analytical method validation, verification, and transfer activities are appropriately executed, reviewed, documented, and maintained throughout their lifecycle.
• →Initiate, access, review, and implement change controls affecting laboratory equipment, methods, specifications, software, procedures, sampling plans, and laboratory operations.
• →Support Research & Development by reviewing new and updated specifications for accuracy and coordinating analytical testing for finished product expiration studies and plant trials.
• →Perform other duties as directed by the Quality Manager or as assigned.

Provides technical and operational leadership for the Quality Control Laboratory supporting the manufacture and release of regulated products. Ensures raw materials, bulk and finished products, are sampled, tested, reviewed, and dispositioned in accordance with approved specifications, validated/verified analytical methods, cGMP requirements, and site Quality Systems. Provides leadership for laboratory personnel, analytical investigations, data integrity, laboratory equipment and computerized systems, method lifecycle activities, stability testing, and inspection readiness. Ensures laboratory investigations, deviations, OOS/OOT results, and CAPAs are scientifically sound, timely, and compliant. Drives laboratory performance, analyst competency, continuous improvement, and reliable delivery of accurate analytical results to support product quality and release decisions.

• Bachelor’s degree in relevant scientific discipline
• A minimum of 5–7 years of progressive Quality Control laboratory experience required
• Minimum of 2 – 3 years of direct supervisory experience required
• Experience leading CAPA Investigations
• Experience working under 21 CFR Part 211 / cGMP

• Knowledge of FDA regulations for quality control of OTC drug products (21 CFR 211), quality control test procedures and instrumentation, and validation protocols and procedures.
• Strong technical knowledge of analytical laboratory principles, test methods, and instrumentation, including wet chemistry, gas chromatography (GC), high-performance liquid chromatography (HPLC), ion chromatography (IC), and UV-Visible spectroscopy.
• Working knowledge of laboratory computerized systems including LIMS, chromatography data systems, electronic records, and data integrity.
• Strong leadership and people-management skills, with demonstrated ability to coach and develop laboratory personnel, manage performance, prioritize laboratory workload, and ensure appropriate training and analyst qualification.
• Strong problem-solving and critical-thinking skills with the ability to evaluate complex analytical issues, assess product-quality and compliance risks, and make timely, scientifically sound decisions.
• Proficiency with Microsoft 365 applications, including Excel, Word, PowerPoint, Outlook, and other business applications used for data analysis, reporting, and documentation.
• Good oral and written communication; excellent organization and time management; ability to interact effectively with employees at all organizational levels.
• Ability to work for extended periods under pressure while producing results.