Job Description

Analytical Quality & Compliance Specialist
Job Number: 21-06321
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for an Analytical Quality & Compliance Specialist for our client in Devens, MA
 
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:
  • Provide QA review and approval for establishment of standardized global procedures and training to the NQC teams standardizing Laboratory Data Systems (LDS) and Equipment Qualification and Software Validation
  • Review and approve QC instrument qualification and software validation documentation, including any associated deviations ensuring root cause and robust CAPAs have been identified
  • Review and approve global procedures at local sites considering existing local site CAPAs and procedures
  • Support inspection/audit readiness activities related to network documentation
  • Review and approve select, key multi-site and network deviations concerning laboratory methods
 
Qualifications:
  • Minimum of 5 years' experience in the (bio) pharmaceutical industry, with at least 2 years within a QA role
  • In depth knowledge of cGMP regulations pertaining to instrument qualification, computer system validation and QC operations. Knowledge of 21CFR part 11, EU Annex 11 and GAMP regulations
  • Data analysis to identify trends and their root causes
  • Self-directed with a high degree of professional integrity, organization, and attention to detail
  • Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision
  • Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations
  • Matrix team leadership
  • Innovative problem solving and growth mind-set
 
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:
Jay Lucas
arjay.lucas@eclaro.com
6463571240
Jay Lucas | 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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