Compliance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)
  3. United States
Boston, USA
Posting date: 23 Mar 2021

Proclinical is currently recruiting for a Compliance Specialist with a pharmaceutical company located in Boston, MA.

Job Responsibilities:

  • Responsible for generating, reviewing, providing assessments and maintaining out of specification (OOS) reports, deviation reports, CAPAs and Change Control for Analytical Sciences.
  • Provide key assistance in QA audits and design correction action to observations
  • Maintain the training matrix of GAPD
  • Conducts reviews of new procedures and proposed changes to current procedures for compliance with regulatory and corporate requirements; presents findings
  • Identifies opportunities for improvement in systems and makes recommendations for effective changes to ensure compliance with cGMP
  • Oversee equipment maintenance including maintaining PM calendar, schedule calibration and services, review, approve and maintain equipment binders and log books
  • Maintain Inventory of reference standards, critical samples and reagents. Coordinate qualification of reference standards and prepare qualification reports.
  • Create timelines and plans to meet established targets; goals and objectives

Skills and Requirements:

  • Bachelor's Degree or higher
  • Experience with quality improvement projects
  • Experience with Trackwise or equivalent quality system for change control, deviation, CAPA, Lab Investigation
  • Experience with Veeva Vault EDMS or equivalent

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.