- Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements.
- Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
- Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
- Establish and maintain policy for documentation of all products and perform internal documentation audits.
- Author and review relevant SOPs, validation and other documents.
- Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
- Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review.
- Control Master Batch Records, distribution and label verification.
- Perform line clearance activities as required.
- Assign and maintain product lot numbers as applicable.
- Ensure materials management nonconformance disposition and release activity as applicable.
- Ensure 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.
- 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.
- Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks.
- Provide support to manufacturing for investigations of deviations, validations, and development of specifications
- Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements.
- Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted.
- Perform employee training on QSR and ISO requirements and company quality systems
- Perform document control activities as assigned.
- Mentor/train/develop and manage Quality Assurance team.
- Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements
- Travel may be required
- BS Degree in biological sciences or equivalent.
- Minimum 5-10 years related experience in the pharmaceutical or biologics industry.
- Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
- Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc.
- Sound knowledge of aseptic processing and supporting technologies.
- Analytical and technical troubleshooting skills are a plus.
- Proficient with Microsoft Office Suite.
- Excellent organizational skills and attention to detail.
- Good verbal and written communication skills.
- Strong team-oriented interpersonal skills are essential.
- Strong business acumen
- Relevant IT skills (able to work with Visio, Microsoft Project and Excel)
- Ability to think strategically and tactically (detail-oriented)
- Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
- Analytical and problem-solving skills
- Strong written and oral communication skills
- Meeting management/facilitation skills/teamwork
- Ability to multi-task is essential
- Flexible and able to adapt to company growth and evolving responsibilities
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