Job Description

Analytical Quality & Compliance Specialist
Job Number: 21-06100
 
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!
 
Position Overview:
  • Will support the execution of Quality activities that fall within the Quality Key Brands organization
  • Support of End to End Biologic Annual Product Quality Reviews (APQRs) for commercial Key Brands, as well as supporting other key QPC initiatives and programs
  • Will work collaboratively with QPC Management and QPC Project Managers and will also collaborate with the various brand teams and the global Quality organization to reach compliant solutions
 
Responsibilities:
  • Support QPC Project Managers in managing Biologics End-to-End Annual Product Quality Review for assigned brands
  • Support the authoring of End-to-End Annual Product Quality Reviews (APQRs) for Key brands
  • Perform reviews of documents prepared by other team members for completeness, accuracy, structure, and grammar
  • Support the interpretation and analysis of quality data related to End-to-End APQRs
  • Work closely with various brand teams and global Quality organization to communicate specific timelines to team members to ensure on-time deliverables are completed
  • Support continuous improvement projects to improve Quality Systems and processes, supporting the team with development and utilization of tools for providing standardized work and communications for APQRs and other initiatives
  • Perform other related duties and assignments
 
Qualifications:
  • Bachelor's degree or equivalent experience
  • Experience as a project manager/coordinator or technical writer within the biopharmaceutical industry or GxP environment
  • Excellent technical writing skills with ability to edit materials to ensure accuracy, clarity, and consistency
  • Ability to work collaboratively with cross-functional teams
  • Strong interpersonal, verbal, and written communication
  • Proven track record of successful management of projects and ability to meet critical timelines
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology processes or cell therapy products
  • Expertise with MS Office, Word, Excel, Sharepoint, Teams, and document management systems
 
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:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | 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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