Quality Assurance Supervisor

JCW Group; Fort Collins (CO); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Competitive compensation and benefits package

Stable long-term work environment

Job summary

JCW Group is seeking a qualified QA leader to join their team at their Fort Collins location in Colorado. This role involves overseeing a QA team in a cGMP manufacturing environment on the night shift, ensuring compliance and quality across operations.

The ideal candidate will exhibit strong leadership and communication skills, with a minimum of 6 years of QA experience in the pharmaceutical or medical device industry. A bachelor's degree in a scientific field is preferred.

Qualifications

• 6+ years of experience in quality assurance (QA) within the pharmaceutical or medical device industry.
• Familiarity with a cGMP regulatory environment or ISO 13485 standards.
• Adept in handling investigations and deviations in QA documentation.

Responsibilities

• Supervise a QA team for night shift manufacturing operations.
• Oversee daily quality operations including inspections and product sampling.
• Review and approve GMP documents and minor deviations.
• Identify training needs and manage employee performance documentation.
• Provide data for KPIs and support continuous improvement initiatives.

Skills

QA experience in pharma or medical devices

Knowledge of cGMP and/or ISO 13485

Investigations, deviations, and document management systems expertise

Strong written/verbal communication

Team leadership skills

Education

Bachelor’s degree in a scientific field

Job description

This well-established specialty pharmaceutical company develops and manufactures complex niche dosage forms. With a strong emphasis on quality, compliance, and patient-centered decision-making, the organization has built a collaborative culture that invests in its people and promotes continuous improvement across all levels of the business. Employees benefit from a competitive compensation and benefits package, along with a stable, long-term work environment.

What They Are Looking For

A hands‑on QA leader who can hit the ground running on night shift and provide strong day‑to‑day oversight of a QA team in a cGMP manufacturing environment. The ideal candidate is someone who leads by example, communicates clearly across departments, and takes ownership of quality systems without needing heavy directions.

Responsibilities

• Supervise a team of QA associates supporting night shift manufacturing operations (Sunday–Wednesday, 5:00 PM – 5:30 AM with every other Wednesday off).
• Oversee daily quality operations including material/labeling inspection, finished product sampling, manufacturing support, and product retains.
• Review and approve GMP documents, minor deviations, certificates of analysis, and investigation reports.
• Identify training needs, administer competency-based training, and manage employee performance documentation.
• Provide KPI data and support continuous improvement initiatives across QA and manufacturing departments.

Requirements

• 6+ years of QA experience in pharma or medical devices
• Knowledge of cGMP and/or ISO 13485
• Experience with investigations, deviations, and document management systems
• Strong written/verbal communication and team leadership skills
• Bachelor’s degree in a scientific field preferred