SENIOR QUALITY ASSURANCE SPECIALIST

Job Responsibilities:

Maintain a visible cGMP compliance presence and provide Quality Assurance input
into decisions regarding the quality of biologic Drug Substance during routine
operations and when deviations occur in the following areas Inoculum,
Fermentation, Purification, Materials Management, Facilities, Warehouses and
Cryogenics facilities. This includes performing pre operational checks and
responding to deviations in progress. Provide direction, coaching and support
to personnel in areas assigned to ensure compliance with cGMPs, regulatory
guidelines, corporate policies and site procedures. Includes direct quality
oversight during defined critical operations. Work closely with Technical
Services and Manufacturing operations representing the Quality Assurance
organization in investigating deviations or compliance issues associated with
daily manufacturing operations activities. Responsible for responding to
deviations when they occur and taking the appropriat e action required to
ensure integrity of systems are maintained and address product quality related
issues as required. Responsible for on the floor review and approval of
manufacturing batch records, logbooks and associated documents as determined by
Supervisor. This position will require rotation between first, second and third
shift, weekends, holidays and on call responsibility as required.

Job Requirements/Education:

B.S. degree in a scientific or engineering discipline. Generally a minimum of
six to eight years of experience in the pharmaceutical or biologics industry.
Three to five years related experience in broadly based Quality Assurance
activities. Experience in Biologics manufacturing is highly desirable.
Demonstrated the ability to work independently and when deviations occur
represent the Quality Assurance department in making timely decisions that
ensure the integrity of systems are maintained and the appropriate course of
action is taken with regard to maintaining product quality. Demonstrated the
ability to consistently make sound judgments ensuring compliance with
regulations under tight timelines and be flexible and capable of handling
changing priorities. Extensive knowledge and understanding of cGMPs, FDA
regulations, ICH guidelines, in particular how they relate to manufacturing
operations and batch record documentation. Previous experience in the review
and approval of manufacturing batch records or related documentation for cGMP
compliance is highly desirable. Two years experience in conducting
investigations related to manufacturing and or laboratory deviations is
desirable. Ability to communicate clearly and succinctly, both verbally and in
writing. Topics are often of a complex technical nature or pertain to the
interpretation of regulatory documents. Strong interpersonal skills including
ability.

Salary will be commensurate with experience.
Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D