Job Description

Sr. Quality Specialist
Job Number: 21-05249
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Sr. Quality Specialist for our client in New Brunswick, NJ
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Responsibilities:
  • Lead, develop, and manage a robust process relating to supplier change notification
  • Execute and improve network procedures for Client 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. supplier change control, vendor management, supplier scorecard, quality agreements, approved supplier list, material qualification, reduce testing, etc.)
  • Knowledgeable of supplier change notification and change control. Primary resource for change control
  • Lead supplier change notification metrics/KPI generation and reporting
  • 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
  • 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
  • Required to coordinate with site stakeholders for troubleshooting purposes relating to suppliers
  • May be expected to lead cross-functional project team
  • Expected to participate in the training of less experienced personnel as well as assisting less experienced personnel in normal operational tasks
 
Qualifications:
  • 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
  • 6-9 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. change control, 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 cGMP processes
  • 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, SAP, 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 in order to exchange information regarding supplier quality as it relates to meeting department goals and objectives
  • Should be observant of 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
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Jane Bautista
froilyn.bautista@eclaro.com
2012858622
Jane Bautista | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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