Quality Assurance Document Control

Philadelphia, PA

Posted: 05/26/2023 Division: Life Sciences Job Number: JN -052023-16979

Job Description

Quality Assurance Document Control
  • Title: Quality Assurance Document Control
  • Location: Philadelphia, PA
  • Industry: Pharmaceutical
  • Hours: M-F 11am - 7:30pm (Onsite)
  • Salary: Up to $27 based on experience (Paid Weekly - Benefits Available)
  • Employment Type: 12 Month Contract (potential for direct hire)
Environment: 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 customer s 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.

Minimum Requirements:
  • High School Diploma required with relevant industry experience.
  • Must have 1 year experience in GMP Laws (Good Manufacturing Practices).
  • Prefer batch record review experience.
  • Must be proficient in use of computers and Microsoft Office.

Job Scope:
  • 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.
  • Coach new QADC staff through day to day activities when needed.
  • Communicates SQDC counter measures and safety issues to Quality Management.
  • Ensures QADC metrics are met or takes action to correct.
  • Complies with EH&S and 5S requirements for QADC.

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent. EOE/ADA
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