FSP QA Auditor I

QA Auditor I

Join us as 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.

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: