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Quality Assurance Associate
2 months ago
Pay: $50/HR to $59.50/HR
Shift: Sunday to Tuesday with alternating Wed (12-hrs each day) Working hours are 6am to 6:30pm ***
Job Description:
- Provide direct manufacturing Quality Assurance support for all GMP activities at HTO/HDC.
- Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support.
- Assure compliance with cGMP regulations, Company standards, and applicable Regulatory standards.
- Resolve Quality Assurance issues and develop solutions for complex problems following cGMP regulations
- Work independently within broad guidelines and policies.
- Maintain a state of inspection readiness.
- Sign documents for activities as MQA as described by policies, procedures and job descriptions.
- Review batch records in the Aseptic Operations, Inspection, and Packaging areas.
- Complete Additional Actions in the Discrepancy Management System as assigned.
- Interact with interdepartmental contacts on discrepancy assessment and resolution.
- Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product.
- Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
- Support process improvement initiatives.
Qualifications:
- Bachelor`s or Master`s degree (preferably in Life Science or Engineering) with 4-7 years of experience in the pharmaceutical industry and at least 2 years in a quality role.
- In-depth industry experience in aseptic GMP Drug Product filling and quality oversight for manufacturing processes and discrepancy management
- Ability to perform physical activity including, but not limited to lifting, standing for periods of time, and gowning into production space\
- Knowledge of cGMPs and Health Authority expectations
- Experience reviewing manufacturing documentation
Browse our website below for additional information on our company.
The Fountain Group
4505 Woodland Corporate Blvd, Tampa, FL 33614
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.\r
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Browse our website below for additional information on our company.\r
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The Fountain Group\r
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4505 Woodland Corporate Blvd, Tampa, FL 33614\r
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”