QA Deviation Reviewer

QA Deviations Reviewer
Summit, NJ- Hybrid
6 month W2 contract (with potential to extend or transition to perm)
Pay rate: $80-90/hr/hour - Depending on Education and Experience

Summary:
This role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight for Manufacturing Operations and QC laboratories; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.

Some of the Your Responsibilities:

• Supports all activities for the Quality Operations Investigations group.
• Provide quality oversight of Manufacturing Operations, QC Chemistry and QC Microbiology.
• Work with manufacturing and laboratory management to ensure activities comply with global regulatory requirements.
• Ensure procedures are adequate and confirm appropriateness of raw data.
• Review and approve manufacturing and QC laboratory investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
• Ensure site is compliant with global and regulatory data governance and data integrity requirements
• Ensure control of systems, processes and product through supporting review and approval of change notices and change control. Review site change controls and ensure appropriate requirements are identified and completed for implementation.
• Establishes and maintains procedures to ensure data integrity is maintained and procedures/processes are compliant.
• Assess global standards/policies and emerging regulations.
• Ensure the site stability program meets global and regulatory requirements.

Skills or Requirements:

• Must have advanced knowledge and experience with cGMP manufacturing, Quality, and Compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
• Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
• Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
• Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific

initiatives and activities by interdisciplinary teams. - Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching other and analytical thinking.

• Is recognized Subject Matter Expert within the group.
• Understanding of aseptic manufacturing processes.

Education/Experience:

• B.S. degree required; advanced degree preferred.
• Minimum 3-5 years Quality Control and/or Quality Assurance experience in a pharmaceutical company with CAR T or Biologics experience preferred.

What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities [1]to contact us if you are an individual with a disability and require accommodation in the application process.

Links:
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[1] https://www.yoh.com/applicants-with-disabilities
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