About the Opportunity
Our client is a well-established North American manufacturer with a long-standing reputation for quality, innovation, and operational excellence. They are seeking a Quality Assurance Supervisor to join their team and support pharmaceutical-grade manufacturing operations at their Facility Outside Dallas, TX.
This is an excellent opportunity for a quality professional with experience in USP-regulated manufacturing who is looking to take the next step into a leadership role while working in a highly regulated production environment.
Position Overview
Reporting to the Quality Manager, the Quality Assurance Supervisor will play a key role in ensuring compliance with pharmaceutical and regulatory standards while supporting quality systems, laboratory operations, and continuous improvement initiatives.
The successful candidate will help oversee day-to-day quality activities, support regulatory audits, supervise laboratory personnel, and ensure products consistently meet customer and regulatory requirements.
Key Responsibilities
- Ensure compliance with USP specifications, GMPs, and applicable regulatory requirements.
- Support investigations of customer complaints, including root cause analysis and corrective actions.
- Assist with regulatory, customer, and internal quality audits.
- Promote and support a strong food safety and quality culture throughout the facility.
- Oversee laboratory testing, product release activities, and Good Laboratory Practices (GLP).
- Review Certificates of Analysis (COAs) and quality documentation.
- Develop, review, and maintain Standard Operating Procedures (SOPs) and quality records.
- Coordinate laboratory testing schedules with production operations.
- Lead validation studies and support continuous improvement initiatives.
- Monitor laboratory equipment calibration and maintenance.
- Review quality trends and prepare required compliance reports.
- Supervise and schedule laboratory technicians.
- Assist with employee training related to quality systems and regulatory compliance.
- Order laboratory supplies and testing equipment as required.
Qualifications
- Bachelor's degree in Chemistry, Biology, Food Science, or another related scientific discipline.
- Minimum 2 years of experience in a USP-regulated pharmaceutical manufacturing or quality laboratory environment.
- Strong understanding of pharmaceutical regulations including:
- 21 CFR Part 210
- 21 CFR Part 211
- ICH Q7
- Previous supervisory or team leadership experience is considered an asset.
- Experience conducting investigations, CAPA activities, and regulatory documentation.
- Strong organizational, analytical, and problem-solving skills.
- Excellent verbal and written communication abilities.
- Ability to work collaboratively with cross-functional teams in a fast-paced manufacturing environment.
What You'll Bring
- A proactive, self-motivated approach to quality and continuous improvement.
- Strong leadership and coaching skills.
- Excellent attention to detail and documentation practices.
- The ability to prioritize multiple projects while maintaining compliance with regulatory standards.
- A commitment to product quality, safety, and operational excellence.
Why Apply?
- Join a stable and respected manufacturing organization.
- Competitive compensation and comprehensive benefits.
- Opportunities for professional growth and advancement.
- Collaborative team environment focused on quality and continuous improvement.
- Play a key role in ensuring products meet the highest regulatory and customer standards.
Interested?
If you're an experienced quality professional with a background in pharmaceutical or USP-regulated manufacturing, we'd love to hear from you. Apply today for a confidential discussion about this opportunity.