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.
The Quality Systems Associate III is responsible for the effective processing, monitoring and reporting of the One Lambda Inc. Audits, Complaints, UDR, NCR and CAPA programs including provision of status and trending report for upper management in accordance with company policy and procedures. Ensure compliance to FDA and ISO regulations with respect to the Quality Management System. This position is expected to work independently. Must demonstrate consistent problem solving skills and be able to lead corrective action teams. The level of responsibility for this position is assigned based on the employee’s on the job (OTJ) experience within the position description, as well as demonstrated performance. The department manager will outline specific duties during employee reviews.
- Monitor/address/track quality issues that arise from Audits, Customer Inquiry (CI), Unplanned Deviations (UDR), Non-Conformance (NCR) or from Internal/External quality system audits
- Assist the QA Supervisor and product line/QS process owners with Corrective/Preventive action (CAPA) projects to ensure timely and effective completion of required activities
- Determining non-conforming products and materials disposition (implementing QA quarantines and/or release of affected inventory)
- Ensure all nonconforming product(s) are identified and removed from use
- Conduct internal audits and support external audits
- Gathers information from multiple departments (Customer Service, Product Specialists, Product/Process Owners and Regulatory) in order to assist RA and process owners with the determination of risk related to a reported Nonconformance
- Responsible for the assignment of CAPA actions (corrective/preventive action requests) to NCRs
- Ensure completion and accuracy of all associated quality records related to nonconformance and CAPA reports
- Manage the performance and documentation of Internal Audits and support External Audits, as required
- Lead and/or participate in product related team meetings and/or performance reviews, as needed
- Assist with QA department functions as needed. (Specific duties may vary and will be documented in department records, job assignments and/or project action items)
- Perform computer operations for data entry, and provide tracing/trending reports
- Additional support of routine QA department standard operating procedures (SOPs) is also expected when necessary
- Bachelor’s degree in Biological Sciences or a related field
- Six (6) years of experience in a Quality regulated environment
- Able to create presentations, work with spreadsheets, prepare reports and write procedures utilizing
- Experience with MS Word, Excel and PowerPoint software applications
- Detailed knowledge of ISO and GMP regulations which govern a medical device and diagnostics manufacturing
- Knowledge of statistical process controls and GMP CAPA requirements
- Tracking and trending tools and reporting techniques
- Provide accurate QS tracking and trending reports.
- Good procedural writing skills a plus
- Exercise independent discretion and judgment in execution of duties
- Plan and organize oneself in a consistent manner
- Be a self-starter with the ability to positively motivate others in a cooperative fashion
- Establish and maintain effective working relationships with other staff members
- Effectively communicate both orally and in writing to management, customers and regulatory personnel
- Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry
- Background in diagnostics
This position has not been approved for relocation.
At Thermo Fisher Scientific, each one of our 50,000 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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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