Quality Assurance Field Operations
- Employer
- Bristol Myers Squibb Company
- Location
- Syracuse, NY, United States
- Start date
- Sep 8, 2019
View more
- Discipline
- Manufacturing & Production, Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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
*Shift: 12 hour rotating (6pm - 6am), EOW, 3/4 - 4/3
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.
Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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