Quality Specialist - Validation (GMP) Job at R&D Partners, Durham, NC

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  • R&D Partners
  • Durham, NC

Job Description

Primary Responsibilities of role:

  • Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation.
  • Assures compliance with SOPs upon implementation. Investigates and proposes additional corrective actions as required.
  • Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.
  • Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:
  • Write test cases to validate critical control points, user requirements, and functional designs.
  • Execute test cases as needed.
  • Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process:
  • Prepares validation equipment for use at the Donor Center and for evaluation upon return.
  • Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment, including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service.

Qualifications:

  • Bachelor's degree with experience in quality and validation in a GMP/pharmaceutical space
  • Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.
  • Power BI would be a significant plus. Excel is required

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

  • Medical insurance – PPO, HMO & HSA
  • Dental & Vision insurance
  • 401k plan
  • Employee Assistance Program
  • Long-term disability
  • Weekly payroll
  • Expense reimbursement
  • Online timecard approval

Pay Scale:

$72,000 - $83,000/annually

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

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