FSP QA Auditor I

Work Schedule

Environmental Conditions

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 Youll 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:
Bachelors degree or equivalent and relevant formal academic / vocational qualification; Associate degree and relevant experience is acceptable in lieu of bachelors 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. Youll 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 tomorrows breakthrough.

Compensation and Benefits

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: Experience:

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