QMS Specialist I

As a QMS Specialist I, you will be at the heart of the mission to enable customers to make the world healthier, cleaner, and safer. This role is a pivotal entry-to-mid-level position within our Quality Assurance department, focusing on maintaining the integrity of our Quality Management Systems (QMS) in a fast-paced, regulated environment.

Role Information

The QMS Specialist I is responsible for ensuring that all site operations remain compliant with current Good Manufacturing Practices (cGMP) and corporate standards. You will collaborate with cross-functional teams to oversee document control, training modules, and change management processes.

Key Responsibilities for the QMS Specialist I

1. Change Control & CAPA: Maintain the site change control system and oversee the execution of Corrective and Preventive Actions (CAPA) to ensure product quality is never compromised.

2. Documentation Management: Author and review Standard Operating Procedures (SOPs) and Work Instructions (WIs) while ensuring all GxP records.

3. Audit Readiness: Coordinate inspection readiness activities and support both internal self-inspections and external regulatory audits (e.g., FDA or EMA).

4. Digital Systems: Utilize specialized software like TrackWise and eDMS to track quality events and manage data integrity across the site.

5. Training & Compliance: Develop the annual GMP training plan and improve training modules to foster a culture of quality excellence.

Qualifications for the QMS Specialist I

1. Education: A Bachelor’s degree in Chemistry, Biology, Biotechnology, or Engineering.

2. Experience: 1–3 years of relevant experience in a pharmaceutical or biotech environment (fresh graduates with strong academic backgrounds in Quality Systems may be considered).

3. Technical Skills: Proficiency in cGMP regulations and experience with quality management software.

4. Soft Skills: Strong analytical thinking, effective communication, and the ability to drive results in a collaborative setting.