QA lead technical operations

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Direct message the job poster from Bristol Myers Squibb

• Provides quality support through quality review and approval of investigations or change controls.

• Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of laboratory operations including, incoming, in-process, release, and stability testing.

• Reviews and approves laboratory periodic trending and performance reports

• Liaises with internal partners (e.g., Quality control, analytical technology functions) in support of daily operations and conflict resolution

• Review and approval of validation/qualification/verification protocols and reports associated with new product or material entry.

• Ensures clear communication on issues and timely escalation as applicable

• Helps maintain site practices and procedures related to laboratory instrument qualification, usage, and method execution and trending, ensuring compliance with regulatory expectations

• Drives opportunities for continuous improvement.

• Conducts quarterly walkthroughs of Quality Control laboratories

• Represent QA in cross functional meetings

• Support Network functions as QA review and approval on qualification/ technical protocols and reports

• Support Quality initiatives outside QA function; acts as area system owner

Knowledge and 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 quality operations desired

• Knowledge of biotech bulk and finished product manufacturing and associated analytical testing is highly desirable.

• Knowledge of US and EU cGMP regulations and guidance.

• Knowledge of electronic systems including any of the following: LIMS, Veeva, LES, Empower, DCA, Maximo desirable

• Past experience where one was required to work in a team based environment with a diverse group of people.

• Excellent writing and oral communication skills are required

• Demonstrated attention to detail, and the ability to perform well in a team-based environment are required.

• Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, and apply knowledge of subject matter expertise

• Excellent computer skills and proficiency with MS Office is required.

• Contacts are primarily with Quality Assurance and QC operations, as well as Clinical Manufacturing.

This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb.

The starting hourly compensation for this assignment is the following range ($54-$56.42/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed.

The starting hourly compensation may be subject to change.

About ASK Consulting

ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes—across IT, healthcare, engineering, finance, and more—with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers.

ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.

Equal Opportunity Employer

ASK Consulting is an equal opportunity employer and does not discriminate against employees or…