Quality Manager

Job Title: Quality Manager Location: Winston-Salem, North Carolina Type: Direct Hire Compensation: $85-90k Work Model: Onsite Hours: 7/8 AM- 4/5 PM, occasional OT and Saturdays

Responsibilities

• Lead and manage the Quality Department, including QA/QC operations.
• Ensure compliance with GMP, Quality Management Systems, and regulatory requirements.
• Oversee product release testing, incoming inspections, NCMRs, CAPA activities, and product disposition.
• Ensure all raw materials, bulk solutions, and finished goods meet specifications.
• Conduct risk assessments and support quality-related decision making.
• Investigate product failures, nonconformances, and customer complaints.
• Perform trend analysis and implement corrective and preventive actions.
• Manage internal audits and support external regulatory audits.
• Lead supplier corrective action (SCAR) activities.
• Develop and maintain quality documentation, policies, procedures, and training programs.
• Support new product development by creating quality plans and ensuring design control requirements are met.
• Assist with product validation, equipment qualification, and product transfers to manufacturing.
• Partner with Engineering, Production, R&D, Regulatory, and Corporate Quality teams.
• Drive continuous improvement initiatives focused on product quality, process control, risk reduction, and cost improvement.
• Supervise contracted QC technicians as needed.
• Maintain a safe work environment and ensure compliance with safety requirements.

Requirements

• Bachelor’s degree in Biology, Chemistry, Engineering, Biotechnology, or related scientific field.
• 3-5+ years of Quality Assurance and Quality Control experience in cosmetics, chemicals, or a related manufacturing environment.
• Experience with Quality Systems implementation, IQ/OQ/PQ validation, test plan development, root cause analysis, statistical methods, and Design of Experiments (DOE).
• Knowledge of NCMR and CAPA processes.
• Experience with AQL/statistical sampling.
• Hands-on analytical laboratory experience, including raw material inspection and microbiology testing.
• Experience using laboratory instruments such as HPLC, FTIR, viscosity meters, and pH meters.
• Experience with incoming material sampling and FTIR material identification.
• Strong critical thinking and problem-solving skills.
• Proficiency in Microsoft Office; advanced Excel skills preferred.
• Experience with MasterControl document control is a plus.
• Fluent English required; Spanish is a plus.
• Ability to lift up to 35 pounds and work in lab, office, and production environments.
• Ability to travel up to 10% annually and work extended hours as needed.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #LI- Ref: #558-Scientific