Job Description
Quality Control (QC) Equipment Technician
Location: Norwood, MA (100% On-Site) Schedule: Day Shift, Monday - Friday
Contract Length: 6 month with potential extension
About the Role
We are seeking a highly motivated and independent QC Equipment Technician to be the operational and compliance expert for all laboratory equipment within our state-of-the-art biopharmaceutical Quality Control (QC) facilities. This specialized role is critical for ensuring the continuous qualification, calibration, and maintenance of high-precision analytical instrumentation, directly supporting the compliance and integrity of our clinical and commercial testing programs.
Key Responsibilities
The QC Equipment Technician manages the full lifecycle of laboratory assets and supports the robust quality system that governs their use:
Equipment Lifecycle & Maintenance
- Coordinate and schedule calibration, maintenance, and Installation, Operational, Performance Qualification (IOPQ) activities with Facilities, Metrology, and QC end-users to minimize equipment downtime and address Out of Tolerance (OOT) events immediately.
- Monitor, coordinate, and communicate equipment lifecycle timelines—from acquisition and induction to qualification, implementation, and decommissioning—utilizing project management tools.
- Submit asset induction, work, and administrative requests to ensure equipment failures are addressed immediately and data in the Computerized Maintenance Management System (CMMS) is accurate and in the proper state.
- Serve as the primary QC point person for all equipment inquiries, acting as the liaison between the laboratory team and appropriate external vendors.
- Ensure all vendor representatives strictly follow site safety and cGMP procedures when working on equipment.
- Perform minor, non-invasive repairs on high-precision systems like UHPLC (e.g., changing capillaries, flow cells, needles/seats) and execute basic troubleshooting to diagnose complex failures.
Quality & Compliance Documentation
- Support the authoring, review, and maintenance of high-stakes quality system records, including Deviations, Change Controls, and CAPAs (Corrective and Preventive Actions) as required.
- Author, revise, and maintain Equipment/Instrument Standard Operating Procedures (SOPs).
- Review preventative maintenance reports, calibration certifications, CMMS records, and perform system inventory audits to ensure compliance.
- Ensure all equipment documentation meets stringent cGMP, GDP (Good Documentation Practices), and data integrity requirements (ALCOA+) throughout its operational life.
- Ensure all tasks are performed in compliance with safety and cGMP requirements.
Inventory & Logistics
- Order supplies and maintain inventory for equipment consumables and accessories.
- Assist with locating and collecting assets due for service and returning them to the laboratory promptly once service is complete.
Basic Qualifications
- Education: Bachelor's degree (BS) in a relevant scientific discipline (e.g., Chemistry, Biology, Engineering, or related field).
- Experience:
- Minimum of 5 years of experience in a regulated laboratory setting with a BS degree.
- OR Minimum of 3+ years of experience in a GMP Quality Control (QC) laboratory setting.
- Knowledge: Demonstrated aptitude and ability to learn quickly to develop a strong understanding of GxP principles (cGMP, GLP).
- Skills: Proven expertise in laboratory equipment IOPQ, calibration, maintenance, and troubleshooting. Familiarity with electronic Quality Management Systems (eQMS) and CMMS software.
Job Tags
Contract work, Immediate start, Monday to Friday, Day shift,