Night QA Supervisor - FDA-Regulated, 3rd Shift

EPM Scientific

Lancaster (SC)

On-site

USD 75,000 - 85,000

Full time

14 days+

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Job summary

EPM Scientific Lancaster site is seeking a Quality Assurance Supervisor for the 3rd shift to oversee quality operations on a fast-paced manufacturing team in Lancaster, South Carolina. The role emphasizes FDA compliance, cGMP adherence, and continuous improvement.

The ideal candidate will mentor staff, manage deviations and non-conformances, and drive quality improvements while collaborating with cross-functional teams to ensure product integrity and regulatory readiness.

Qualifications

4-5+ years in FDA-regulated manufacturing or production environment.
Minimum of 3 years of Quality Assurance experience.
Experience reviewing and managing SOPs, batch records, deviations, non-conformances, and quality documentation.
Strong leadership, mentoring, and performance management skills.
Knowledge of FDA regulations, cGMP, ISO standards, Lean manufacturing.

Responsibilities

Supervise and support Quality Assurance personnel during 3rd shift operations.
Ensure compliance with FDA regulations, cGMP requirements, company policies, and internal quality standards.
Review and approve quality documentation, including batch records, deviations, non-conformances, and corrective actions.
Partner with Manufacturing, Operations, and cross‑functional teams to resolve quality-related issues.
Lead investigations related to deviations, non-conformances, and process exceptions.
Monitor production activities to ensure adherence to procedures and quality requirements.
Drive continuous improvement initiatives focused on quality systems and efficiency.
Coach and develop team members through performance management and training.
Address employee performance concerns and ensure policy compliance.
Support audits and regulatory activities as needed.