Job Title : QA Supervisor

Location: Rockville, MD 20850 US (Primary)

Job Type: Full-time

Exemption Type: Exempt

Career Level: Manager

Education: Bachelor's Degree

Job Description

• Ensure current Good Manufacturing Practices (cGMPs) compliance for clinical manufacturing of phase I/II/III investigational biological product, and compliance to 21 CFR Parts 210, 211, and 600 as applicable
• Supervise & provide Quality Assurance support to concurrent Commercial and/or Government cGMP projects.
• Provides direct supervision to Government projects and oversite of project subcontractors
• Reviews testing data as applicable
• Responsible for lot disposition of external and internal lots as assigned
• Supports Supplier audit program as assigned and conduct/assist with supplier audits
• Assist in the preparation of, and host regulatory agency inspections (FDA, EMEA, etc.). Interact with regulatory inspectors.
• Identify and communicate quality or compliance risks and participate in Quality Risk Management efforts.
• Review and approve QS records as assigned
• Supports department objectives, identifying continuous and compliance improvement initiatives, monitor progress of deliverables and provides support to junior associates
• Responsible for staffing plans, monitoring and appraising the performance of direct reports, providing necessary training where required, and maintaining effective communication within the area of responsibility
• Responsible for mentorship and supervision of designated staff to ensure effective execution of roles and responsibilities
• Foster effective and constructive communication and interaction with client departments; Encourage direct reports in effective communication with client departments
• Develop and lead by example a team of client-facing QA Associates
• Ensure current Good Manufacturing Practices (cGMPs) compliance for a commercial biological product and compliance to 21 CFR Parts 210, 211, and 600 as applicable.
• Support new client projects and support providing QA costs (labor, testing, etc.) in collaboration with Client QA Managers and Program Management.
• Supervise the batch record review and lot disposition activities, including raw materials, to ensure the release of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals
• Directs QA on the Floor activities to support manufacturing and testing at the site
• Supervises raw material release
• Supervises AQL inspections
• Supports senior management with the initiation of new client proposals and projects. This includes analyzing client proposals for resource allocation and QA costs generated by Business Development.
• Reviews and approves QS records as assigned
• Facilitates QA support and works closely with other ABL functional units including Manufacturing, Validation, Facilities Engineering, and Quality Control to assess and resolve quality investigations with regards to products manufactured. Ensure corrective and/or preventative action plans to resolve potential product quality issues are appropriately implemented
• Oversees QA Client liaison for supporting routine client audits including coordinating audit support, answering questions, and resolving issues.
• Perform and support internal audits for GMP activities to evaluate compliance with the procedures and practices.
• Actively find new opportunities for process improvement initiatives, that reduce the sites compliance risk, reduce the production cost, and promote a strong Quality Culture
• Other duties as assigned
• More information and to apply - Visit https://careersablinc.hua.hrsmart.com/hr/ats/Posting/view/244