Job Details

  • Title: QA Associate Specialist – Document Control
  • Code: RCI-47596-1
  • Location: Warren, NJ 07059
  • Posted Date: 05/20/2022
  • Duration: 12 Months
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  Job Description

Job Description:              

  • QA Disposition team is committed to actively support client manufacturing site and other departments to ensure cGMP compliant production, testing and release of product on the Warren manufacturing site.
  • The activities include uploading of batch record document, review of batch records, release of raw materials for production and release of finished drug product.
  • This position will be working closely with the QA Disposition management to identify and handle process quality and cGMP compliance related issues, raw materials for production, as well as to contribute to process improvement in his/her scope of activity.

Skills/Knowledge Required

  • At least 1 -2 years of experience in a pharmaceutical company or other related industry.
  • BS or equivalent degree/experience in a relevant discipline in Science or related field.
  • Good understanding of cGMPs and FDA regulatory requirements.
  • Good understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred.
  • Proven interpersonal, collaborative and organizational skills.
  • Works independently on routine tasks, makes proposals and facilitate decision when escalation is needed.
  • Ability to focus attention to details.
  • Good written & oral communication skills.
  • Investigational and problem-solving skills.
  • Knowledge of most common office software (Microsoft Office).

 Duties and Responsibilities

  • Uploads batch record documents
  • Issuance of Controlled Documents
  • Perform release of raw materials for production
  • Supports the deviations and CAPA process by handling deviations and CAPA and executing investigations within assigned areas of responsibility with the support of Manager QA Operations.
  • Represents QA within department and cross-functional project teams according to assignments.
  • Acts as backup for colleagues within QA Disposition Team.
  • Provide general administrative support to the QA Operations
  • Perform batch record review and prepare batch release documentation