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Senior Specialist Quality Assurance - Level II (Associate)

Kenilworth, NJ 07033

Posted: 04/10/2023 Employment Type: Contract Job Category: QA/Automation Job Number: 557521 Is job remote?: No Country: United States

Job Description

Target Pay Rate 25-32.79/hr **salary will be commensurate with experience 

Job Responsibilities:

  • Must have ability to make assessment of technical reports (example: investigations, product release) and determine acceptability based on organizational requirements.
  • Must be able to handle multiple priorities at a time and immediately address urgent issues.Solves complex problems; takes a new perspective using existing solutions.
  • Works independently, receives minimal guidance.
  • Experience with administration and data entry of technical reports into internal databases.
  • Explains difficult issues and works to build alignment around a complex situation.
  • Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
  • Knowledge and competency with various IT systems, including Comet-SAP, Midas (document storage system), Track Wise Complaints system (QCC4), and Track Wise Change Control (GCM). Accountable for medium sized projects with minimal resource requirements, risk and/or complexity.
  • May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others.
  • Strong knowledge of External Manufacturing management, supply chain, and operations.
  • Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as Subject Matter Expert (SME) Communicates easily in English both verbally and in writing.
  • Lean Six Sigma Systems training an advantage.
  • Fluent in English language (reading, writing and speaking)

Primary Activities may include, but are not limited to the following:
  • Evaluate and release products to other sites with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations.
  • Manage routine and complex deviations and complaints and assist in the coordination of significant investigations; assist in the coordination of report closures required by the external manufacturer.
  • Support routine and complex change requests and support process modification change controls.
  • Provide guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.
  • Track and monitor operational and quality performance of the external manufacturer and work with supplier to develop CAPA plans, as needed.
  • Gather, interpret and report, in a timely manner data for internal Annual Product Review (when required).
  • Participate with site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.

  • Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent)
  • Previous experience within the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control.
  • Must have working knowledge of regulatory expectations for the manufacture and/or testing of pharmaceutical products and/or Medical Devices Combination Products, with experience in quality, manufacturing, process validation and/or process technology transfer processes.
  • Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills.
  • Experience with Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.

**CO/NY candidates may not be considered
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