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Field Quality Assurance Operations, Single Use Facility

Employer
Bristol Myers Squibb Company
Location
Devens, MA, United States
Start date
Feb 25, 2019

Job Details

Provide Quality assistance and oversight during start up of clinical manufacturing facility and manufacturing of clinical/commercial drug substance. Performs review and approval of records for the manufacture of in-process materials, drug substance and other GMP processes as required. Assists in the identification, generation and review 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:

1. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate as well as site procedures, regulations, and other industry guidelines.

2. Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs.

3. Performs walkthroughs of the manufacturing facility and applicable support areas documenting observations and points of concern.

4. Supports return to service walkthroughs and other walkthroughs per procedures as needed.

5. Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing and support area related SOPs.

6. Monitors and trends batch record error and right-first-time batch record review cycle times.

7. Supports disposition and provides Quality Assurance management with quality indicator data. Supports the Quality review and closure of low risk investigations.

8. Participates in the creation of a team based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals.

9. Demonstrates appropriate examples of compliance behaviors and attitudes. Supports on the floor activities in collaboration with Manufacturing and additional support groups as needed.

10. Other duties as assigned.

Education/Experience/Skills:

- 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 quality, validation or manufacturing operations.

- Knowledge of biotech bulk manufacturing, disposable technologies and analytical testing is highly desirable.

- Knowledge of US and EU cGMP regulations and guidance for clinical and commercial phase products is preferred.

- Knowledge of electronic and paper batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable.

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.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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