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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