Quality Assurance Supervisor

The Imagine Group, An Imagine Company; Lancaster (SC); Presencial; USD 85 000 - 100 000; Tempo integral

Resumo da oferta

The Imagine Group is recruiting a Quality Assurance Supervisor for the 2nd shift at an FDA-regulated nutritional supplement manufacturer in Lancaster, SC. The role leads QA Inspectors, Label Issuance staff, and Team Leads, ensuring cGMP compliance and production quality.

You will oversee QA activities, document control, deviation investigations, and support regulatory readiness while fostering continuous improvement and lean manufacturing practices.

Qualificações

• 4–5 years in FDA-regulated manufacturing or production
• At least 3 years in quality assurance or quality control
• Experience in nutritional supplements and/or pharmaceutical manufacturing
• Strong knowledge of cGMP, SOPs, batch records, deviations, nonconformances, and quality documentation
• Leadership supervisory experience and supervision of teams

Responsabilidades

• Supervise QA Inspectors, Label Issuance staff, and Team Leads; coach, drive accountability and policy compliance
• Oversee QA inspection activities, production monitoring, and label cage operations
• Review and approve protocols; update SOPs and batch records for consistency and compliance
• Partner with Production to resolve manufacturing quality issues and collaborate cross‑functionally
• Monitor environmental records, excursions, pest control and calibration records
• Investigate deviations and nonconformances; document corrective actions and NCRs
• Ensure compliance with cGMP, FDA regulations, and company policies; support regulatory readiness
• Develop processes to strengthen compliance and continuous improvement, including Lean practices
• Enforce safety practices and train employees on hazard recognition; review corrective actions
• Coordinate incident response with EHS and participate in root‑cause analyses
• Communicate across shifts and adjust hours as needed
• Perform additional duties as assigned

Conhecimentos

Quality leadership

cGMP knowledge

QA/QC experience

SOP proficiency

Regulatory compliance

Cross-functional collaboration

Lean manufacturing

Problem solving

Training & coaching

Formação académica

Associate or Bachelor’s degree in science

Descrição da oferta de emprego

Quality Assurance Supervisor – 2nd Shift

Location: Lancaster, SC

Pay Range: $85,000 - $100,000 base salary; eligible for up to 15% annual bonus (not guaranteed)

Work Type: Full-Time

Work Model: Onsite

Work Schedule: Monday – Friday, 3:15pm – 11:30pm (initial training on 1st shift)

No C2C, C2H, 1099 or H1-B Sponsorship/Transfer

Positional Overview

The Imagine Group is recruiting for a 2nd Shift Quality Assurance Supervisor on behalf of our client, an FDA-regulated manufacturer of nutritional supplement products committed to product quality, regulatory compliance, and continuous improvement.

Reporting to the Quality Assurance Assistant Manager, this supervisor leads Quality Assurance Inspectors, Label Issuance personnel, and Team Leads. The role oversees daily QA operations, production monitoring, quality systems, and the consistent application of current Good Manufacturing Practices (cGMP). The successful candidate will combine hands‑on quality expertise with strong people leadership, accountability, conflict resolution, and a continuous‑improvement mindset.

Role & Responsibility:

• Supervise and develop QA Inspectors, Label Issuance staff, and Team Leads; provide coaching, performance accountability, conflict resolution, and consistent policy enforcement.
• Oversee QA inspection activities, production‑process monitoring, and label cage operations and personnel.
• Review and approve protocols; review SOPs, processes, batch records, and procedures, and update documentation to improve consistency and compliance.
• Partner with Production Supervisors to resolve manufacturing and quality issues, and collaborate with Production, New Product Development, and other departments on quality‑system activities.
• Monitor environmental‑condition records, respond to excursions, and review pest‑control, calibration, and related quality records.
• Investigate deviations and nonconformances; assess potential effects on product quality, safety, and purity; prepare and close NCRs and document corrective actions.
• Ensure compliance with applicable cGMP requirements, FDA regulations, industry standards, and company policies; support product quality and regulatory readiness.
• Develop and implement processes that strengthen compliance, operational consistency, and continuous improvement, including Lean manufacturing practices where applicable.
• Enforce safe work practices, identify and correct unsafe conditions, train employees on hazard recognition, and follow up on corrective measures.
• Coordinate incident response and reporting with EHS and appropriate response teams; support incident investigations, including 5-Why root‑cause analysis and corrective actions.
• Communicate effectively across shifts and departments; periodically adjust shift hours to support personnel on other shifts.
• Perform additional duties as assigned.

Skills & Experience

• High school diploma required; an Associate or Bachelor’s degree, preferably in a science‑related field, is preferred.
• 4-5 years of experience in an FDA- regulated manufacturing or production environment, including at least 3 years in Quality Assurance or Quality Control.
• Experience in nutritional supplements and/or pharmaceutical manufacturing.
• Strong working knowledge of cGMP, SOPs, batch records, deviations, nonconformances, and quality documentation.
• Experience with ISO standards, dietary supplements, and Lean manufacturing practices is desirable.
• Prior FDA or equivalent regulatory inspection experience is highly preferred.
• Demonstrated supervisory leadership, including difficult employee conversations, performance accountability, conflict resolution, and policy compliance.
• Strong cross‑functional communication skills and a commitment to continuous improvement.
• Ability to work the stated second‑shift schedule, train initially on first shift, and periodically support other shifts.