Job Title: QA Change Control and Audit Specialist
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
- Manage the Change Control system (75% time allocation), which includes:
- Sitting on all Change Control Team meetings
- Input of all Change Requests into a tracking system
- Following up on open changes with owners to ensure they are resolved and dispositions are made in a timely manner
- Generate and monitor metrics for report out in Management Review and use these metrics to address improvement opportunities.
- Improving the Change Control system as it moves into a more automated database
- Own Change and Internal Audit procedures
- Train to Change and Internal Audit processes and tools
- Manage Internal Audit System (25% time allocation), which includes:
- Ensuring the Internal Audit Plan for Ward Hill and Tewksbury sites is adhered to as required by ISO9001
- Coordinate with internal auditors to cover the requirements of the internal audit plan
- Participate in internal audits as necessary
- Document findings and communicate to affected department heads
- Track findings and ensure the commitment dates are met
- Track Internal Audit metrics for reporting at Management Review
- Familiarity with CAPA as required by ISO 9001
- Participate in other QMS efforts such as CAPA, Non-conformances, document control, training, supplier quality, etc.
- Participate in PPI (continuous improvement) events
- Perform other duties as assigned
- Observes all departmental and Quality System procedures and work instructions.
- Supports Thermo Fisher Scientific’s commitment for continuous improvement by documenting process improvement opportunities thorough the Quality System.
Environmental, Health & Safety Responsibilities:
- Follows and abides by all EH&S policies, practices, and procedures in association with department specific responsibilities
- Demonstrates technical and procedural proficiency and self-assuredness in applying EH&S standards
- Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers
- Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated
- Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department
- Support the Company’s commitment for environmental health & safety by applying ISO 14001
- Proficient knowledge of Internal Auditing and Change Control practices in accordance with standards such as ISO9001
- Process creation and implementation experience required for Change Control
- Experience with QMS databases such as Master Control and TrackWise, including process improvement, user requirements, user acceptance testing
- Skilled at reporting metrics showing performance and trending; advanced data analysis skills a plus
- Ability to manage numerous priorities and activities in parallel (project management)
- Certified, experienced internal auditor to ISO9001
- 3 years of experience in Change Control
- Knowledge of the most recent version of ISO9001 and pending regulatory changes
- Experience auditing to 21CFR preferred
- Ability to review current processes and implement productivity and compliance improvements
- Strong “people skills” to be able to deal with various personalities and levels within and outside of the organization
- Excellent verbal and written communication skills; ability to write reports required.
- Excellent organizational skills and be detail oriented
- BS in a technical field with at least 5 years of experience in a manufacturing environment. Equivalent and relevant experience may be considered in place of degree
- Experience in working in a chemical warehouse environment a plus
Physical Demands and Work Environment:
- This position may require some lifting (up to 20 lbs. or heavier weights with assistance). Must be able to work an 8 - 12 hour shift while walking, standing with periodic sitting. Must be able to handle chemicals in a safe manner while donning appropriate personal protective equipment
- Required to wear ASTM F 2413-05 (or ANSI Z41-1999) safety shoes, eye shields and laboratory coat while working in the warehouse. No shorts or dresses allowed on the warehouse floor
At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com