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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