What are the responsibilities and job description for the Manufacturing Compliance Specialist position at Accupac?
Basic Job Functions:
This position is responsible for conducting thorough investigations, drafting, and documenting deviations, ensuring compliance with internal and regulatory standards. Ensure all investigations are conducted in accordance with current Good Manufacturing Practices (cGMP) regulations, aiming to identify root causes, propose corrective actions, and prevent recurrence of problems while maintaining compliance with regulatory standards.
This position will collaborate with internal Subject Matter Experts (e.g., Operations, Quality Assurance, and other relevant teams) to gather information related to deviations. Additionally, this role will collaborate with customers to ensure timely reporting of Quality incidents and customer concurrence with audit findings and Corrective and Preventive Actions (CAPAs). This role requires strong analytical/problem solving and communication skills as well as computer skills.
Essential Functions of the Job:
- Lead investigations into Manufacturing Quality Events and customer complaints.
- Perform root cause analysis using industry standards, such as 5 Why?s and Fishbone diagrams.
- Determine relevant corrective and preventative action.
- Perform risk assessment to determine the safety and efficacy of product.
- Oversee timely completion of deviations, CAPAs, investigations, complaints.
- Track and trend events/deviations.
- Provide communication plans for ongoing deviations and CAPAs.
- Assists in technical transfers for new and existing commercial products into Accupac.
- Support the Manufacturing department with Electronic Batch Records (EBR).
- Maintain tracker of EBR configuration work progress.
- Assist in troubleshooting and resolving various issues in the manufacturing department using analytical and statistical analysis.
- Develop, review, and revise Standard Operating Procedures (SOPs)
- Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards and sanitation practices.
- Proactively raises quality related risks, issues, and opportunities.
- Support the organization in maintaining a work environment focused on quality, respect, effective communication, collaboration, integration, teamwork, and professionalism.
- Other duties as assigned.
