Manages GMP quality system including documentation & equipment change control, product complaints, audits and CAPA; Performs quality review of production documentation, Certificates of Analysis, and leads implementation of continuous improvement initiatives.
Responsibilities and Duties:
- Conducts and internal, external and quality customer audits of SDIX. Coordinates and reviews final remediation plans and responses for audits and submits to customers for review.
- Leads all internal quality investigations.
- Reviews all new and revised manufacturing/operations SOPs from a quality perspective.
- Lead the customer feedback process and serve as system “owner” and administrator. Responsible for investigating and closing out non-conformances within the quality system. Maintain SOP and metrics and provide ongoing reports for management.
- Assist in the development of new and/or improved methods for production/product testing and review documents to be used in production and testing as needed.
- Maintain and analyze quality records and logs to identify anomalies and trends, and monitor completion of action items.
- Performs final review of lot records and related production documentation and releases material for shipment to customers, provides final QA sign off.
- Communicates urgent quality issues to Director of QA/QC and quality team; Provides quality metrics on a on-going basis to help assure management oversight of quality issues.
- Administers and acts as gatekeeper for the document control and management system.
- Conducts training programs for Quality and in the use of quality processes and tools.
- Maintains database on required training programs, needs and participants
- Reviews Certificate of analysis and other critical documents as required.
- Perform additional duties as assigned by management.
Qualifications: (Knowledge, Skills and Abilities: Education, Experience, Job Skills, Equipment Skills, and Certifications)
- BS/BA in a life sciences discipline.
- Minimum of 5 – 10 years QA experience.
- Working knowledge of cGMP regulations; FDA Part 830, ISO 13485 and CE Marking.
- Working knowledge of quality system operation.
- Proficient with general laboratory methods
- Computer literacy to include Office products.
- Consistently meets shipping deadlines
- Document control system maintained and functioning
- Ability to train on GMPs, document control and Quality systems
- Ability to manage staff and improve on their efficiency and knowledge
- Optimize processes to reduce need for re-testing
Work Environment / Other Requirements:
At SDIX LLC our work environment varies significantly from job to job. Ability to lift or move 25 pounds and work/travel throughout plant environment of varied temperatures and humidity; grasp and hold small objects, a full range of motion, and to wear personal protective devices. This position may expose the employee to fumes or airborne particles, biohazards, and toxic or caustic chemicals. Daily contact with employees in other departments is required.
Job Type: Full-time
Salary: $55,000.00 to $65,000.00 /year
Job Type: Full-time
- Quality Assurance: 5 years (Preferred)