FSP QA Auditor I

Thermo Fisher Scientific • Worcester, MA

2d • Onsite

About The Position

Join us as a QA Auditor I and play a crucial role in ensuring compliance and excellence in our clinical auditing processes. This role supports the IQA/SQA group and is responsible for specification revisions of Commodities (CMS) and Raw Materials (RMS) specification documents. The individual is not expected to be a subject matter expert but will manage the revision process. This role also works as a liaison between operating groups and the Document Control group to facilitate the identification, writing, reviewing, and approval of all documents to support a given project. The QA Auditor I will route and monitor document change control packages, managing revisions through effectiveness, and manage timelines to support manufacturing. A key responsibility is maintaining the specification revision database for tracking documentation changes and ensuring accuracy of status reports. The role involves participating in project team meetings as a representative for the QA group, ensuring overall GMP compliance through coordination of documentation, batch record review, and other means. Additionally, the QA Auditor I serves as a resource to operational departments on audit or quality assurance subject matter.

Requirements

• 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
• Microsoft Office suite, OneTrack, OneVault, SampleManager

Nice To Haves

• 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.

Responsibilities

• Support IQA/SQA group as responsible for specification revisions of Commodities (CMS) and Raw Materials (RMS) specification documents.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree