What are the responsibilities and job description for the Quality Assurance Senior Specialist (MN) position at CEDENT?
The Quality Assurance (QA) Senior Specialist will provide lead oversight to ensure our quality systems are robust, compliant with regulatory standards, and continuous improvement. The QA Senior Specialist will be responsible for developing and revising site procedures, leading investigations and corrective actions, participating in regulatory inspections, coordinating quality metrics, and ensuring the highest standards of product quality across the manufacturing process.
Description
PRINCIPAL RESPONSIBILITIES:
Description
PRINCIPAL RESPONSIBILITIES:
- Procedure & Documentation Management:
- Support the development, review, revision and approval of site procedures, work instructions, and training materials to ensure alignment with regulatory requirements and industry best practices.
- Ensure procedures are followed and updated as necessary to maintain compliance with Good Manufacturing Practices (GMP) and other relevant standards.
- Investigation & CAPA Oversight:
- Review and approve investigations, Corrective and Preventive Actions (CAPAs), and Change Controls, ensuring thorough documentation and timely resolution of quality issues.
- Collaborate with cross-functional teams to investigate non-routine and complex quality issues, identifying trends, corrective actions, and recommendations.
- Regulatory Inspections:
- Participate in regulatory inspections (e.g., FDA) and represent the quality assurance team, ensuring that all quality systems are fully compliant.
- Address and resolve any regulatory concerns, ensuring prompt corrective action and comprehensive documentation.
- Customer Complaints & Quality Event Resolution:
- Investigate customer complaints and quality events, serving as the GMP QA approver. Ensure that root cause analysis is conducted, corrective actions are implemented, and documentation is completed within required timeframes to prevent recurrence.
- QA Metrics & Performance Monitoring:
- Develop and monitor key quality assurance metrics and performance indicators (KPIs) to assess the effectiveness of quality systems and ensure regulatory compliance.
- Identify trends and areas for improvement, making recommendations to enhance quality processes.
- Batch Record Review & Product Disposition:
- Review and approve batch records to ensure completeness and accuracy and make final decisions regarding product disposition based on established criteria and quality standards.
- Internal & External Audits:
- Conduct internal audits of GMP Quality Systems and subsystems, ensuring compliance.
- Participate in third-party audits, collaborating with external auditors to ensure adherence to quality standards.
- Risk Assessment & Mitigation:
- Support regular risk assessments to identify potential risks to product quality and compliance.
- Assist in the development of strategies to mitigate risks and ensure quality standards are maintained.
- Material Evaluation & Approval:
- Oversee the examination and evaluation of components, containers, closures, in-process materials, packaging, labeling, and finished dosage forms, ensuring they meet established specifications before approval or rejection.
- Incoming Material Disposition:
- Lead the evaluation and disposition of incoming materials to verify they meet quality standards and specifications before use in production.
- Continuous Improvement Leadership:
- Lead and participate in continuous improvement initiatives to enhance quality processes and systems, improving operational efficiency and ensuring the highest standards of product quality.
- Cross-functional Collaboration & Problem-Solving:
- Collaborate with manufacturing and technical teams to identify root causes of problems and develop appropriate corrective actions for investigations.
- Consult cross-functionally to resolve complex issues, trends, and quality challenges, balancing technical, regulatory, and business requirements.
- Quality Assurance Leadership:
- Provide QA oversight on investigations, making recommendations for targeted data and information collection required for quality events.
- Provide quality assurance support during site inspections by the FDA and other regulatory agencies.
- Manufacturing Support & Oversight:
- Maintain a quality presence on the manufacturing floor, overseeing active manufacturing processes and ensuring compliance with GMP standards.
- Review records for compliance with CGMPs, procedures, and ensure manufacturing and analytical equipment is maintained and calibrated.
- Training & Documentation Control:
- Act as a key trainer for GMP training programs, ensuring that all personnel are adequately trained on quality systems and regulatory requirements.
- Assist with document control and maintain a strong training program to support compliance.
- Supplier Qualification & Material Testing:
- Support Supplier Qualification processes and review testing protocols for in-house and external solutions/materials.
- Safety & Compliance:
- Actively promote safety awareness and good safety practices across the organization.
- Report and correct safety and environmental hazards as part of your role to maintain a safe working environment.
- Additional Responsibilities:
- Perform other duties as assigned by management to support continuous quality improvement and compliance efforts.
- Bachelor’s degree in a related field (e.g., Life Sciences, Engineering, Chemistry) or equivalent experience in Quality Assurance required.
- Minimum of 3 years of experience in Quality Assurance within the pharmaceutical, biotech, or related industry required.
- Experience leading investigations, CAPAs, and audits within a GMP-compliant environment required.
- Experience of on the floor support for manufacturing operations required.
- In-depth knowledge of GMP, FDA regulations, and industry best practices, specifically 21 CFR 210, 211 in the FDA.
- Strong written and verbal communication skills, with the ability to collaborate effectively across teams.
- Demonstrated problem-solving skills with the ability to analyze complex issues and implement effective solutions.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Ability to communicate with and positively influence broad and diverse populations within and outside the organization.
- Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Engineering, Operations, Research and Development teams.
- Working knowledge of Microsoft Office Suite specifically Microsoft Word and Excel strongly preferred.
- Working knowledge of Adobe editing software strongly preferred.
- Working knowledge of working in hybrid QMS system (paper/electronic).
- Extended hours, night shift and weekend work may be required occasionally
- Ability to work in a cleanroom and sterile compounding environment, adhering to strict health and hygiene standards to ensure the safety and quality of drug products.
- Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.
- Chronic health conditions that prevent long-term performance of essential job functions may require evaluation and could affect employment status.
- Proper garbing and personal hygiene must be maintained at all times when in the cleanroom or compounding areas.
