Quality Specialist II
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJob Responsibilities:
Review validation projects, protocols, and reports in support of equipment and process validation.
Write and review protocols and reports.
Review IQ/OQ protocols and reports.
Assist in Risk Assessment exercises in support of validation activities.
Collaborate with R&D, Product Development Manager, Technical Operations, and Operations to ensure successful process development and technical transfers.
Coordinate validation activities/reviews in support of assigned validation projects working closely with Subject Matter Experts.
Recommend approval or failure of validation studies.
Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and current interpretations affecting equipment, product, and process validation.
Act as a resource to other departments for product and process knowledge.
Able to work independently, with guidance from the Quality Assurance team.
Ability to learn new products and technology.
Able to successfully lead a project involving a peer group.
Lead and/or participate in product related team meetings and/or performance reviews, as needed.
Assist with QA department functions as needed.
Perform computer operations for data entry and provide tracing/trending reports.
Minimum Requirements:
Bachelor’s degree in Biology, Chemistry, or other similar Life Science field, or equivalent experience.
2+ years proven experience in Quality regulated environment.
Detailed knowledge of ISO and GMP regulations which govern a medical device and diagnostics manufacturing.
Proficient in creating presentations, managing spreadsheets, generating reports, and drafting procedures using MS Word, Excel, and PowerPoint software applications.
Consistently demonstrated validation proficiency, with knowledge of equipment qualification (IQ/OQ/PQ), process validation, and computer/automation systems.
Good analytical skills, with an ability to use scientific knowledge and statistical methods to identify root causes of process and product failures.
Strong project management and organizational skills.
Demonstrated technical skills in process validation & concepts with an emphasis on implementation.
Excellent verbal and written communication skills.
Previous experience in problem-solving methodology.
Possess a continuous process improvement mentality and manage change.
Performs other duties as assigned.
Compensation and BenefitsThe salary range estimated for this position based in California is $66,000.00–$99,000.00.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-rewardsThermo 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.