QA Operations Associate II -2nd Shift (1:30-10pm) - New Albany, OH

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. This position requires working closely with other departments on production issues/situations, product dispositions and investigations into root causes for deficiencies.

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 equipment and room clearance qualification.
Conduct accurate verifications and checks and during in-process inspections
Identify out of specification product, ensuring segregation and escalation, as required
Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements, providing guidance to plant personnel on document corrections and investigations
Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements.
Conduct component and raw material release
Conduct chart monitoring, ensuring escalation, as required
Support product shipping activities and perform quality related oversight and verifications
Generate controlled documents such as logbooks and labels.
Review Bills of Materials
Achieve and maintain clean side gown and sterile side gown qualifications
Participate in Media Fill and maintain qualification.
Partner with other departments to implement timely procedural changes and resolve compliance issues.
Provide guidance to plant personnel on documentation and investigations
Able to perform tasks with minimal error rate.
Perform any other tasks/duties as assigned by management.
Basic knowledge and application of cGMPs and supporting regulatory documents
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.
At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred.
Experience in QA working in a cGMP manufacturing environment (preferred)
Working knowledge and understanding of quality assurance principles and familiarity with QA programs
Strong analytical skills, attention to detail and adherence to procedures
Demonstrated ability to effectively work under dynamic constraints
Strong organizational, interpersonal and communication skills (oral and written).
PC Skills Required (MS Word, Excel)
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.