FSP QA Auditor I

Thermo Fisher Scientific • Worcester, MA

22h • $26 - $43

About The Position

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

Requirements

• 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.
• 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

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