Job Description

　　As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

　　How will you make an impact?

　　This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The QA/QC Supervisor is responsible for driving the day-to-day GMP Quality Control and Quality Assurance activities for the Vacaville CA Commercial site and ensures site level compliance. This position supports the continued development of GMP capability and maintenance of compliance to US FDA Quality System Regulations and performs site level Quality Control activities. Also works closely with the Maryland QA Manager to ensure consistent Quality Control activities among sites.

　　What will you do?

　　Support Quality Control staff that report directly to them within the Quality matrix.

　　Conduct PMD(s) for direct reports in collaboration with Quality management.

　　Conduct Quality Control inspections and reviews of Operational activities such as receiving, shipping and inventory.

　　Assess for suitability, components and products and approval or rejection of incoming materials, in-process materials and drug products.

　　Ensure that quality documents, protocols and records are current, accurate and properly utilized.

　　Oversight which ensures that developed procedures and specifications are appropriate and followed.

　　Monitor Operational Quality: Through consolidation of key quality characteristics of processes, trend analysis and reporting through the Quality Assurance dashboard for identification of satisfactory and/ or unsatisfactory trends and conditions, as well as monitoring resolutions to result in systematic prevention of defects and non-conformances.

　　Manage Continuous Improvement Activities: Drive functional strategy, the creation, update and consolidation of necessary SOPs, change control and collection of data or measurement of critical compliance values as part of the Fisher BioServices continuous improvement plan.

　　Ensuring necessary qualification, reviewing resource needs with other functional managers for the benefit of the overall organization.

　　Host site level audits by clients and regulatory authorities.

　　Conduct internal audit and supplier vendor audits, as necessary

　　Support the maintenance of a competency-based training program.

　　How will you get here?

　　Education:

　　Minimum required education: Bachelor's Degree in Scientific/Technical field (i.e. Chemistry, Biology, or Engineering).Experience:

　　3+ years cGMP hands-on experience in Quality required.

　　Knowledge of GMP regulations and their appropriate application to assure compliance with regards to manufacturing problems required.

　　Knowledge of software compliance (21CFR; Part 11) required.

　　Thorough knowledge of cGMPs for medical devices or pharmaceuticals (preferred).

　　Knowledge, Skills, and Abilities:

　　Problem solving skills in situations that are not procedurally managed.

　　Proficient with personal computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly.

　　Effective communication skills are required, both written and verbal.

　　Problem solving skills are required in situations that are not procedurally managed.

　　Adept in attention to detail/follow up.

　　Excellent interpersonal skills, problem solving skills, planning/organization skills, strategy and customer focus.

　　Ability to handle multiple tasks while ensuring timely and accurate completion.

　　Ability to work independently.

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　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.

　　Accessibility/Disability Access

　　Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

　　*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

　　Compensation and Benefits

　　The salary range estimated for this position based in California is $83,300.00–$125,000.00.

　　This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

　　A choice of national medical and dental plans, and a national vision plan, including health incentive programs

　　Employee assistance and family support programs, including commuter benefits and tuition reimbursement

　　At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

　　Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

　　Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

　　For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

　　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.