Quality Assurance Floor Support Lead, 2nd Shift
- Employer
- Bristol-Myers Squibb Company
- Location
- Devens, MA, US
- Posted
- Apr 12, 2018
- Ref
- R1504242
- Discipline
- Quality, Quality Assurance
- Hotbed
- Genetown, Ideal Employer
- Required Education
- Bachelors Degree
- Position Type
- Full time
Summary:
Provide Quality assistance and oversight during manufacturing of in-process intermediates and drug substance, and other GMP processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
Responsibilities:
Knowledge/Skill:
Provide Quality assistance and oversight during manufacturing of in-process intermediates and drug substance, and other GMP processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
Responsibilities:
- 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.
- 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.
- Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.
- 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.
- Contributes to driving innovation through continuous improvement of quality processes as well as supporting manufacturing continuous improvement initiatives.
- May provide guidance to less experienced staff.
- Supports the Quality review and closure of manufacturing investigations.
- Other duties as assigned.
Knowledge/Skill:
- 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 with at least 2 years focused on product quality.
- Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
- Knowledge of US and EU cGMP regulations and guidance.
- Knowledge of electronic batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable.