12 days old

QA Reviewer

Kelly Services
Ledgewood, NJ 07852
Position Responsibilities:

Perform first Quality review and release of executed batch records.

Review and certify component release documentation and released raw material documentation for production use.

Review of specific in-process, and finished product test data.

Document retrieval from local files and archives, as required for submissions.

Assist in process audits and internal audits as needed.

Report Error Weekly Metrics (Right the First Time) found during review to Management.

Works closely with Production functional teams to align and promote awareness on data integrity and good documentation practices.

Report of weekly/monthly/quarterly metrics (Right the First time, Error free and Success Rate) to Management.

Facilitate and Coordinate with Project teams to enhance, improve and streamline batch records cycle time.

Navigate through various online platforms, including Oracle, Rescop, etc.

Facilitate and support online platforms implementation.

Initiate product non-conformance investigations and deviation investigations and track as necessary.

Assist in inter-departmental training and provide compliance guidance to personnel.

Perform inter-departmental tasks as requested.

Routine interaction with other departments for purposes of collecting batch record information or working to resolve documentation issues.

Requirements and Qualifications:

Must have experience in a CGMP regulated environment and have worked in a pharmaceutical, Biotechnology or medical device manufacturing facility. Some technical writing experience, SOP & CAPAS

Ability and willingness to work and participate effectively in a team environment.

Ability and willingness to maintain accurate and factual hard copy and electronic records.

Attention to detail, safety, quality and customer requirements.

Ability to effectively communicate verbally and in writing to peers and management.

Ability to read information and apply what is described in the reading material to situations that may contain several details or describe processes involving several steps.

Demonstrate high level of personal motivation and initiative.

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-09-06 Expires: 2021-10-07

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QA Reviewer

Kelly Services
Ledgewood, NJ 07852

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