QA Sr. Specialist

Job Description

Ideal candidate will have strong experience in deviation, QC data review, quality events, QA operations, documentation and batch review. Sr Specialists will be executing disposition and Quality on the Floor (including walkthroughs) activities per the Quality Ops task list

Monday-Friday 1st shift

REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES

Key Leadership Skills

• Cross- functional collaborator
• Results Driver

Key Knowledge / Skills and Competencies

o Ability to independently lead cross-functional teams and represent the Quality unit

o Ability to communicate effectively across all organizational levels

o Ability to evaluate quality matters and make decisions utilizing risk-based approach

o Expert knowledge of GMP requirements governing oral drug products manufacturing practices

o Proven experience supporting GMP manufacturing either via experience in manufacturing and / or experience providing QA operational support of GMP manufacturing

KEY RESPONSIBILITIES :

REQUIRED EDUCATION AND EXPERIENCE :

o Cell and gene therapy cGMP's and associated CMC regulatory considerations

o Aseptic processing

Pay ranges between $55-65 / hr based on experience

Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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