Remote: CMC QA Consultant (229926)

Life Sciences & Technology | Quality Assurance & Quality Control
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Job Description:

Our client is looking for a CMC QA Consultant for a 12 month contract. This individual will assist with external quality and external manufacturing efforts. This is a late stage, Phase III life cycle project and will require oversight and impromptu strategic input on specific matters. This role maintains heavy involvement with GMP requirements and working with external CMO’s from a quality perspective. Primary functions consist of management of CMO, meeting PPQ and tech transfer commercial readiness. Other functions will include record review/approval, production records, batch records, quality management records, change control, investigations, deviations, approving SOP’s, protocol reports and supporting prep of MAA and BLA.

 

Required Skills:

  • 8-10+ years experience within Biologics or Gene Therapy, CMC, QA, CMO Oversight, GMP requirements, tech transfer, commercialization, PPQ’s
  • Education: B.S. Degree in Life Sciences Discipline preferred – Experience outweighs degree
  • Plus/Nice to have: Gene Therapy, CTD/eCTD development, auditing experience, Pre-Approval Inspections (PAI’s)

 

 

Remote: CMC QA Consultant (229926)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

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