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QA Manager

Rockville, MD 20850

Posted: 08/18/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 482215 Is job remote?: No Country: United States

Job Description


• Develop, monitor and maintain policies and procedures to ensure that all activities related to manufacturing and testing for IND product comply with phase appropriate cGMP regulations and client’s quality requirements.
• Establish the process for disposition and release of Drug Product for clinical use, including but now limited to timely management of batch record review, resolution of deviations, review and approval of in-process and lot release testing records, issuance Certificates of Analysis.
• Perform a product safety risk assessment, including but not limited to sterility assurance, Chain of Identity, cross contamination prevention, as well as manufacturing consistence.
• Manage suppliers and contractors to ensure contractual obligations and quality requirements are met.
• Lead and resolve complex quality issues and works closely with other functions to resolve significant compliance trends and issues.
• Provide quality leadership and direction for regulatory, internal and supplier/contractors/clinical sites audits and ensure appropriate and timely response, corrective and preventive action, and completion.
• Support and maintain the quality management system, including deviation handling, change control, CAPA, training, product complaint and recall using a phase appropriate and risk-based approach
• Streamline the quality operations, including but not limited to material management, supplier oversight, document control, facility and equipment oversight
• Improve the procedures and operation of Data Integrity of client to Ensure that all activities related to manufacturing processes for IND product comply with cGMP regulations.
• Perform other duties as required
*Previous experience in Cell/Gene Therapy preferred. 
 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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