FSP QA Auditor

Work Schedule

First Shift (Days)

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Join us a a QA Auditor I - And play a crucial role in ensuring compliance and excellence in our clinical auditing processes.

• 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.

• 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, One Track, One Vault, Sample Manager.

• 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.

• 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…