Operations Manager for GMP Manufacturing
hace 2 meses
About the Role
We are seeking an experienced Operations Manager to join our team in Manatí, PR. As a key member of our manufacturing operations team, you will be responsible for ensuring that our facilities and processes meet the highest standards of quality and compliance with cGMP regulations.
Key Responsibilities
- Support site inspection readiness by conducting routine walkthroughs, observing practices, and interacting with operational personnel.
- Take QA decisions by applying risk assessment principles to planned and unplanned events, using quality and compliance knowledge, data, and experience.
- Review and approve Deviation Reports, Calibration Out of Tolerance events, and Investigation Reports from a QA standpoint.
- Conduct thorough reviews of deviation investigative work, ensuring reports follow Technical Writing principles and show a systematic Root Cause Analysis methodology.
- Review and approve procedures and GMP documents, ensuring alignment with corporate standards.
Qualifications & Experience
To be successful in this role, you will need:
- Bachelor's degree in engineering or science with six years of experience in a GMP manufacturing environment.
- Three-five years of practical experience in Quality Systems, including conducting and reviewing Investigations, CAPAs, and Change Controls.
- In-depth knowledge of cGMPs, FDA, and EU regulations, as well as strong technical writing skills.
- Able to identify matters requiring urgency and work under fast-paced conditions, with excellent communication skills and interpersonal abilities.
What We Offer
As an Operations Manager at BMS, you can expect a competitive salary of $80,000 - $110,000 per year, depending on experience, plus a range of benefits, including health insurance, retirement plans, and opportunities for professional growth and development.
About Us
Bristol Myers Squibb (BMS) is a leading biopharmaceutical company dedicated to transforming patients' lives through science. With a commitment to innovation, diversity, and inclusion, we strive to create an inclusive culture where everyone can thrive.
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