Job Description
Join us a a QA Auditor I - And play a crucial role in ensuring compliance and excellence in our clinical auditing processes.
What You’ll Do:
- Support IQA/SQA group as responsible for specification revisions of Commodities (CMS) and Raw Materials (RMS) specification documents. Note – this individual is not expected to be a subject matter expert. Expected to manage the revision process. See below for further info.
- Work as a liaison between the operating groups and the Document Control group to facilitate the identification, writing, reviewing, and approval of all documents to support a given project.
- Route and monitor document change control packages, managing a revision through effectiveness. Manage timelines and work to a need-by date to support manufacturing.
- Maintain specification revision database for tracking of all documentation changes to ensure accuracy of status reports.
- Participate in project team meetings as representative for QA group. Ensure overall GMP compliance with project through coordination of documentation, batch record review, and other means
- Serves as a resource to operational departments on audit or quality assurance subject matter
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associate degree and relevant experience is acceptable in lieu of bachelor’s degree
- Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years).
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Familiar with applicable GxP and appropriate regional regulations
- Achieves acceptable standards of quality and meets timelines for QA deliverables and required departmental reports
- Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
- Excellent organizational, detail-oriented, schedule-adherence skills to monitor and progress changes on a priority basis and ensure appropriate revisions are completed, as well as capturing SME input/review.
- Must be able to work independently, set priorities, and establish action plans on a daily basis. Very good problem solving, risk assessment and impact analysis abilities
- Proficient at collaboration, negotiation and conflict management
- Flexible and able to multi-task and prioritize competing demands/work load
- Software that will be used frequently – Microsoft Office suite, OneTrack, OneVault, SampleManager
Working Conditions and Environment:
- Work is performed in an office/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves.
Physical Requirements:
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthrough.
Compensation and Benefits
The hourly pay range estimated for this position based in Massachusetts is $25.60–$38.00.
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
