Bristol-Myers Squibb Company

Quality Assurance - Field Operations

Location
Syracuse, NY, US
Posted
Aug 08, 2018
Ref
R1508715
Required Education
Bachelors Degree
Position Type
Full time
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