FSP 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.

Responsibilities

• 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 but is expected to manage the revision process.
• Act 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.
• Serve 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.

Skills

• 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.
• Ability to work independently, set priorities, and establish action plans on a daily basis.
• Strong 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/workload.
• Proficient with Microsoft Office suite, OneTrack, OneVault, SampleManager.

Working Conditions and Environment

• Work is performed in an office, laboratory, and/or 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 and multi-task.
• Regular and consistent attendance.

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 a 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.

Pay

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.

Schedule

First Shift (Days)