Thermo Fisher Scientific QA Validation Specialist in Florence, South Carolina
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.
Florence, SC / Pharma Services GroupHow you will make an impact
Working independently, this position solves a wide range of difficult calibration and validation issues that impact multiple functions following cGMP regulations and Company standards and serves as technical subject matter expert (SME) in quality oversight of validation. This position does not include supervisory responsibilities, but may include oversight of project teams.
What you will do
Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult calibration and validation issues. Participate in the design and qualification stages of procuring new equipment, automation, cleaning validation and process monitoring. Experience in performing and reviewing temperature mapping studies (chambers, controlled rooms) and operation of associated testing equipment and probes ( e.g. Kaye Validator) Provide input into investigations involving equipment, automation, utility, cleaning validation, process monitoring and facility failures. Administer a change management system for validated equipment, automation, utilities, cleaning validation, process monitoring and facilities. Provide Quality oversight to ensure a compliant preventative maintenance, automation, cleaning validation and process monitoring programs. Identify, design, and implement process and system improvements. Review and approve validation documentation. Collaborate with departments to ensure validation activities are executed efficiently and effectively. Provide input to revised and new policies and procedures to effectively guide validation efforts. Troubleshoot and direct the resolution of Quality issues by fostering effective interdepa1imental and cross-functional partnerships. Maintain a state of inspection readiness. Provide input to the development of personal performance goals and departmental objectives; collaborate with Management to establish and meet targets and timelines. Support routine operations and allocate assigned resources; manage competing priorities. Lead and participate in the design and implementation of department and cross-functional initiatives. Train personnel and internal customers on relevant business processes. Administer, document and maintain the conformance to regulatory requirements and company policies where appropriate through effective utilization of site Quality Systems and tools, as well as direct actions. Serve as the Quality representative on cross-functional and multi-site teams and represent the department on relevant project teams. Sign documents for activities as authorized and described by Company policies, procedures and job descriptions. Perform any other tasks as requested by Management to support Quality oversight activities.
How you will get here
To competently perform this job, a candidate will need the education generally obtained with a BA or BS degree (preferably in Life Science)
Five to seven years of experience in the pharmaceutical or biopharmaceutical industry
At Thermo Fisher Scientific, each one of our 70,000 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.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.