QA Operations Associate I

2 weeks ago

Hilliard, United States National Guard Employment Network Full time
Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps.
Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Nature and Scope

This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Achieve and maintain all required equipment and/or room clearance qualifications.
Conduct accurate verifications and checks as well as accurate process inspections.
Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements, providing guidance to plant personnel with documentation inquiries and corrections.
Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements.
Conduct daily environmental chart monitoring, ensuring escalation, as required.
Support finished and in-process product shipping activities and perform quality related oversight and verifications.
Generate controlled documents such as logbooks and labels.
Basic knowledge and application of cGMPs and supporting regulatory documents.
Achieve and maintain all required gown qualifications.
Perform room, area, and equipment clearances.
Participate in Media Fill and maintain qualification.
Able to perform all tasks with minimal error rate.
Perform any other tasks/duties as assigned by management.

Additional Qualifications/Responsibilities

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred.
Minimum 1 year work experience in an FDA regulated environment or similarly regulated area is preferred.
Must be able to do work independently, if needed.
Strong attention to detail and adherence to all procedures and company policies.
Basic knowledge and skills in Microsoft Word and Excel are required.
Strong organizational, interpersonal and communication skills (written and oral) are required.
Ability to take feedback constructively and function in a team-oriented work environment.
Ability to work overtime as needed.
Physical Environment and Requirements

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
Employee must be able to occasionally lift and/or move up to 25 pounds.
Must be able to achieve and maintain vision requirements in order to perform manual visual inspections of in-process and finished products.

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