Quality Control Manager

Position Summary

The Quality Control Manager will be responsible for leading and overseeing all raw material, component, bulk, and Finished Goods testing activities in accordance with approved specifications, test methods, cGMP requirements, and customer expectations. The QC Manager ensures that the day-to-day tasks are being completed accurately and that KPIs are being met, as well as giving frequent reports to Quality management on adherence to these tasks.  They will work cross-functionally with but not limited to Production, Supply Chain, Purchasing, and Quality Assurance to ensure timely testing and release of materials and products. The ideal candidate will demonstrate strong attention to detail, situational awareness, and the ability to ensure that the quality requirements are fulfilled, as required.

Responsibilities and Essential Duties

• Ensure SOPs are followed to meet and exceed quality standards set forth in specifications.
• Ensure team maintains highest levels of safety to build an environment where the team’s wellbeing is a top priority.
• Track and monitor department KPIs to ensure that items are being released in a timely manner.
• Provide guidance, leadership, and problem solving for the QC Technician positions.
• Ensure proper use of Personal Protective Equipment.
• Collaborate and communicate with upper management and Operations.
• Have a full understanding for the QC Technician job responsibilities.
• Document all results and report all non-conformances to specifications or standards.
• Generate GMP-compliant records as required by SOPs, methods, or regulations.
• Ensure GDP is followed on all applicable packaging documentation.
• Support the company mission, values, and standards of ethics and integrity by incorporating these into the development and implementation of business plans.
• Own and lead special projects as assigned.
• Perform all other assigned duties as required by Quality Management.

Technical Skills Required

• Must possess strong technical skills.  Certification by ASQ as a CQE, CRE, or SSGB is a plus.
• Must have current knowledge of FDA regulations and Good Manufacturing Practice (GMP) regulations.
• Must be able to read, interpret, and apply raw materials, component, bulk, and finished goods specifications, test methods, Certificates of Analysis (COAs), and Certificates of Compliance (COCs) to support material disposition and product release decisions.
• A strong understanding of physiochemical and organoleptic testing principles and be able to evaluate test results against established acceptance criteria.
• Good math proficiency and good color vision.
• Must be able to communicate clearly, orally and in writing, and exchange information accurately.
• Must possess excellent project management skills in order to coordinate multiple projects and adhere to tight timelines while working with people at all levels of the organization.
• Must be self-motivated and possess strong problem-solving and critical thinking skills.
• Must have excellent interpersonal skills in order to effectively meet objectives.
• Must possess proficient computer skills, including Microsoft Office software (Word, Excel, PowerPoint).
• Sage X3 experience a plus.

Experience Required

• High School degree or equivalent.
• Bachelor’s degree in Chemistry, Biology, Microbiology, or related field preferred.
• 6 or more years prior work experience in Consumer-Packaged Goods (CPG), food, pharmaceutical, or manufacturing industry (can be substituted with education or applicable certifications).
• Experience with requirements for Cosmetic and OTC products in line with cGMP and FDA CFR 21 Part 210/211 procedures, as well as knowledge of Safety and OSHA regulations.
• Experience overseeing raw material, component, or bulk testing activities preferred.
• Minimum 3 years in root cause analysis and CAPA development/implementation.
• Experience inspecting and testing in a cGMP environment.

Physical Requirements

• Regularly sit, stand, and walk for extended periods of time.
• Ability to sit, balance, climb, stand, bend, squat, squeeze, kneel, turn, crouch, stoop repeatedly.
• Physically able to lift 50 pounds repeatedly.
• Frequent exposure to varying temperatures, loud noises, heavy machinery, fumes, airborne particles, moving mechanical parts, electrical current, chemicals, and vibrations.
• Frequent use of computer screen and/or scan gun.
• Must be able to discern differences in colors and shades.