Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Summary: Primary responsibility is to maintain a presence and provide Quality oversight, coaching and support to manufacturing groups. Assists in the identification and generation of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
Duties/Responsibilities: Serve as the primary QA contact for multiple manufacturing areas. Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs. Perform walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas. Assisting in deviation/nonconformance identification and resolution acting as team member to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution as required. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines. Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide Quality Assurance management with quality indicator data. Work with operations personnel to resolve issues in a GMP compliant manner. Perform quality tag outs of equipment as required. Support product change over activities.
Knowledge/Skill: Knowledge of biologics manufacturing is highly desirable. Knowledge of US and EU cGMP regulations and guidance. Experience with cGMP documentation review is highly desirable
Education/Experience/ Licenses/Certifications: Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred. A minimum of 4 years of relevant experience in a regulated environment Experience working directly with assurance of product quality is highly desired
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Associated topics: driller, field, field service, ncra, offshore, oilfield, pipeline, representative, spcc, toolpusher
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.