30 days old

Quality Assurance Document Control

Kelly Services
Philadelphia, PA 19133
PAY - $25.00

Temporary for 12 - 18 Months

Hours: 8:00am to 5:00pm

The position requires the individual to prepare customer files, review and approve batch records, and release batch records and finished product. The individual acts as the primary liaison to our customers quality assurance groups for batch record review and release. The position requires communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.

Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.

Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.

Monitor schedule for production priorities.

Attend scheduling meetings when needed.

Review of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures.

Confirm proper randomization schedule utilization for correct patient treatment group assignment.

Primary liaison with client for batch release.

Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation. Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.

Ensure timely release of batch for protocol initiation date.

Release batch within Scheduling database.

Release batch within JDE inventory management system.

Record and track errors and not-right-first-time to maintain departmental metrics.

Archive batch documents onto shared drive and within archive room.

Ensure that responsibilities are completed efficiently while maintaining Quality.

Promotes a positive working environment.

**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: 2021-09-17 Expires: 2021-10-18

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Quality Assurance Document Control

Kelly Services
Philadelphia, PA 19133

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