Job Details

  • Title: Quality Specialist
  • Code: RCI-34860-1
  • Location: New Brunswick New Jersey (NJ) 08903
  • Posted Date: 01/13/2021
  • Duration: 11 Months
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  Job Description

  • Coordinate, develop, and manage a robust process relating to material qualification and certification for the network
  • Execute and improve network procedures for┬ácompany's sites globally.
  • This may requires revisions to procedures for managerial review and approval and drafts documentation where appropriate
  • Train on multiple procedures/processes, and provide support to a wider spectrum of stakeholders in the network
  • SME in multiple aspects of documentation and supplier quality management (i.e. vendor management, supplier scorecard, quality agreements, approved supplier list, material qualification, reduce testing, etc.)
  • Knowledgeable of laboratory reduce testing and material qualification
  • Primary resource for material qualification and certification support
  • Support supplier investigations and trending as needed
  • Act as Quality lead on assigned projects
  • Skilled in writing, reviewing supplier quality agreements and master supplier agreements
  • Knowledge of science generally attained through studies resulting in a BS in the physical or life sciences, chemistry, supply chain, a related discipline, or the equivalent in related experience.
  • 4-7 years of experience in Supplier Quality, cGMP Biologics QC laboratory or related cGLP or cGMP environment.
  • Proficiency (or mastery) of methodologies within QC (i.e. reduce testing, qualification, etc.) and supplier quality (i.e. investigation, non-conformances, corrective actions, agreements, etc.)
  • Attention to detail and demonstrated organizational skills.
  • Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.
  • Proficiency in applying cGMP regulations and compendial testing required.
  • Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
  • Demonstrates leadership, and independent problem solving and analytical thinking skills.
  • Proficiency with common computer software applications (email, MS Office, etc.) and lab based computer applications LIMS, ELN, Maximo or similar, DeltaV or similar, and Infinity or similar.
  • Will work in teams and have continual interaction with members of his/her team as well as other sub-teams within QA/QC in order to exchange information regarding supplier quality and reduce testing as it relates to meeting department goals and objectives
  • Daily contact with her/his manager for work assignments. Routine contact with manager for coaching and general performance management discussions
  • Occasional contact with other management staff relating to specific project responsibilities may be expected
  • May represent Quality in cross functional teams or projects
  • Cross-site/vendor communications as needed for strategic purposes
  • May be required to coordinate with site stakeholders for troubleshooting purposes┬árelating to suppliers
  • Quality Assurance as necessary
  • Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing, laboratory, and/or project timeline
  • Flexibility to work irregular hours and short notice overtime.
  • Specialists should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending and implementing corrective actions.
  • Incumbents normally receive little to no instructions on routine work and assist with the creation of detailed instructions on new assignments.
  • May be expected to lead cross-functional project team
  • Specialist will be expected to participate in the training of less experienced personnel as well as assisting less experienced personnel in normal operational tasks