Quality Control Specialist
hace 4 semanas
Transforming Patients' Lives through Science
Bristol Myers Squibb is a leading pharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled Quality Control Specialist to join our team in Summit West-NJ.
About the Role
The Quality Control Specialist will be responsible for performing routine activities such as preventive maintenance for non-complex and complex equipment/instruments. This will include supporting vendor activities for preventive maintenance, reviewing GMP documentation/records, and training others on general job duties.
Responsibilities
- Perform routine lab housekeeping and lab maintenance activities, such as equipment cleaning, restocking supplies, solution and reagent preparation, etc.
- Review GMP documentation/records, including vendor executed validation documents for GDP adherence.
- May perform document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
- Train others on general job duties including equipment calibration and maintenance processes, as applicable.
- Support creation of equipment User Requirement, validation protocols.
- Collaborate with QC laboratories, Site Engineering, Facility Services and other departments for the commissioning and decommissioning of laboratory equipment.
- Schedule, facilitate and participate in performing the validation, calibration, maintenance, repairs of QC laboratory equipment, whether performed internally or by vendors.
- Maintain electronic equipment database, equipment records and logs, equipment status metrics, and apply equipment status labels in accordance with GMP requirements and written procedures.
- Provide basic and first-line equipment troubleshooting.
Requirements
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- Problem-solving ability/mentality, technically adept and logical.
- Ability to communicate effectively with peers, department management and cross-functional peers.
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Bachelor's degree or equivalent required, preferably in science. An equivalent combination of education and experience in a regulated environment will be considered.
- 1 year experience working in a manufacturing GMP facility.
- 1 year of experience with writing technical documents.
- 1 year QC lab experience.
- 1 year of experience trouble-shooting equipment.
- Knowledge of computerized systems and enterprise applications such as SAP, Valgenesis and Maximo.
Bristol Myers Squibb is an Equal Opportunity Employer
We are committed to diversity and inclusion in the workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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