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Quality Assurance Associate III
2 months ago
- Interfaces directly with client and cross functional teams
- Provides resolutions pertaining to quality for project related issues
- Independently prioritize, schedule, and manage multiple projects and resources (team)
- Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements.
- Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
- Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
- Author and review relevant SOPs, validation and other documents.
- Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
- Responsible for the completion of all client requirements related to cellular product and/or material releases.
- Master Batch Record Control, distribution and label verification
- Perform line clearance activities as required.
- Assignment and maintenance of product Lot numbers as applicable.
- Perform internal documentation audits as assigned.
- Materials management nonconformance disposition and release activity as applicable.
- Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures
- Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
- Track and trend relevant quality metrics including environmental monitoring data.
- Provide Quality Assurance related support to various departments.
- Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
- Electronic Document Control activities as assigned.
- Provide training to personnel as assigned by supervisor.
- Travel may be required.
- BS in biological sciences or other relevant field of study
- 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics.
- Working knowledge and technical understanding of aseptic manufacture of biologics
- Understanding of quality system applications
- Experience in both clinical and commercial manufacturing is preferred.
- Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc.
- Experience in organizing teams for effective and timely completion of projects.
- Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
- Experience participating in or hosting health authority inspections and/or client audits.
- Computer skills (Microsoft Office, Outlook)
- Detail-oriented and organized
- Analytical and problem-solving skills
- Good written and oral communication skills
- Ability to multi-task and be adaptable
- Flexible and able to adapt to company growth and evolving responsibilities
- Ability to work independently and with a team
- Strong Project Management and organization skills
- Must have the ability to work in a team-oriented environment and with clients
- Must be able to work during the weekend, holidays and as required by the company
