FSP QA Auditor

Position: FSP QA Auditor I
Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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 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

Education and Experience:

* 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.

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, One Track, One Vault, Sample Manager

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…