R&D Partners
Location
Chapel Hill, NC | United States
Job description
R&D Partners is seeking to hire a CQA Documentation Specialist in Durham, NC.
Benefits of this role:
Competitive pay
Full-Time role
Benefits + 401k
Your main responsibilities as a CQA Documentation Specialist:
The CQA Systems and Documentation Specialist works with a team of specialists within Clinical Quality Assurance to ensure Clinical and GPV documents are published in the document management system, in compliance with company SOPs and the change request.
Documents include protocols, reports, plans, SOPs, and associated forms.
The specialist manages the lifecycle of the document from the draft stage, through the review and approval processes, and posts documents for training and as effective.
Manage the quality document life cycle process to ensure compliance with company procedures and to meet department objectives
Process change control requests for Clinical and R&D SOPs.
What we are looking for in a CQA Documentation Specialist:
High school diploma or equivalent
Typically requires minimum of 1 year of experience with document systems within a Quality Organization or related area in the Biologics, Biotech or Pharmaceutical industry.
Experience with Documentum systems is a plus
Good Knowledge and understanding of quality and regulatory requirements for the biotechnology and pharmaceutical industry.
Familiarity with quality systems and compliant maintenance of quality-related documentation and records, including knowledge of electronic document control systems.
Why Choose R&D Partners?
Supportive teams
Ongoing contracts
Weekly payroll
Refer a Friend bonus
R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal opportunity employer.
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