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QA Operations Associate II 2nd Shift Job in New Albany, Ohio US

QA Operations Associate II 2nd Shift

PharmaForce, Inc. - New Albany, OH

Posted: 5/28/2020 - Expires: 8/26/2020

Job ID: 218051321

Job Description

American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.

     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

* We all must embrace the     QUALITY culture.

Qualifications and Requirements

* 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 Physical Requirements

*        Employee must be able to occasionally lift and/or move up to 25 pounds.

* 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.

##Job Category: Manufacturing/Production/Operations##

We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
Education Level:
High school graduate
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
Licenses / Certifications:
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