Quality Assurance Specialist - Document Control Coordinator
Rotating Shifts Every 6 Months (Day, Swing, or Night)
Key Details:
- Shift Schedule:
- Day Shift: 7 AM – 8 PM
- Swing Shift: 1 PM – Midnight
- Night Shift: 7 PM – 8 AM
- Shift rotation every 6 months based on business needs.
Role Overview:
As a Quality Assurance Specialist, you will provide daily oversight and compliance support to Manufacturing and Facilities & Engineering teams. Under general supervision, your responsibilities will include:
- Monitoring processes, procedures, and quality systems to ensure compliance.
- Conducting on-the-floor quality oversight and reviewing electronic batch records.
- Revising and approving Standard Operating Procedures (SOPs), work orders, and minor deviations.
- Evaluating compliance issues, providing recommendations, and ensuring timely resolution of quality records.
- Representing the Quality Assurance team in departmental projects and achieving operational goals in a collaborative, matrixed team environment.
Preferred Qualifications:
- Bachelor's degree in Biochemistry, Biology, Chemistry, or a related scientific field.
- Proven experience with GMP operations, including SOP adherence, training, and documentation practices.
- Proficiency in evaluating documentation and operational processes against company procedures.
- Familiarity with Quality Systems, and excellent organizational skills to manage multiple tasks effectively.
- Strong written and verbal communication skills, with the ability to work independently and as part of a team.
- Leadership attributes with a track record of driving process improvements and initiatives.