Job Description

Analytical Quality & Compliance Specialist
Job Number: 20-08543
 
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 focus on the review and approval of technical documents pertaining to GMP analytical methods for biologics drug substances and drug products.
  • Specific technical document types include analytical methods, method protocols and reports, reference standard and critical reagent protocols and reports and COAs, certificates of analysis, analytical change controls and general procedural documents.
  • This QA role will also partner with analytical functional areas to resolve associated protocol deviations and other exceptional conditions, and assist with CAPA identification and resolution.
  • Review and approve analytical method protocol and reports
  • Review and approve qualification and assessment protocol and reports
  • Review and approve GMP procedures
  • Review and approve change controls, CAPAs and Effectiveness Checks
  • Review and approve protocol exceptions/deviation
 
Required Experience:
  • 6+ years of experience in an FDA regulated biotechnology or pharmaceutical industry
  • 4+ years of experience in QA/QC in GMP or GDP environment
  • Working knowledge of QC and analytical test methods for biologics/pharma products
  • Previous experience in QC laboratory executing analytical methods.
  • Experience with reviewing deviations/non conformance/or protocol exceptions is desirable
  • Previous experience using electronic document and deviation management systems (i.e. DCA, Infinity).
 
Required Skills:
  • Ability to manage multiple priorities with aggressive timelines
  • Excellent written, verbal communication and technical writing skills.
  • Strong interpersonal skills and ability to work in a matrix team environment
  • Knowledge of FDA and cGMP regulations and documentation practices.
  • Strong problem solving, conflict resolution, negotiation and independent quality decision making skills.
  • Strong ability to coach/mentor and is self-directed.
 
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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