Job Description

QC Compliance Specialist - Chemist
 
The Quality Control Compliance Specialist will be responsible for supporting compliance in the Quality Control Laboratory, including investigation/deviation management, CAPA tracking, change control, critical facilities/utility qualifications and is GMP compliant.
 

Duties and responsibilities:
  • Laboratory OOS, Deviation, CAPA writing
  • Laboratory instrumentation IOPQ, Maintenance, calibration, troubleshooting and decommissioning
  • Training of Lab personnel and managing of training records
  • Laboratory procedure revisions
  • Responsible for representing and coordinating activities for QC during audits
  • Responsible for ensuring QC compliance with all Federal, State, local and company regulations, policies, and procedures related to GMP, Environment, Health and Safety practices.
  • Identify emerging trends in laboratory compliance (i.e. FDA, ICH, compendial revisions and laboratory safety), practices, policies, and procedures.
  • Identify gaps in practices, policies, and procedures.
  • Ensures procedures and policies stay current when regulations change.
  • Work closely with Quality Assurance (QA) to support and ensure inspection readiness.
     
QUALIFICATIONS
 
Education:
BS / MS in Chemistry, Biochemistry, Microbiology, biology or related discipline is preferred
 
Experience:
  • At least 4 years of experience in a pharmaceutical industry required.
  • Expertise in OOS/OOT/Atypical investigation writing, deviations, change controls, root cause analysis, and monitoring CAPA effectiveness.
  • Knowledge of relevant FDA guidance documents.
  • Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP) a must!
  • Experience statistical analysis to identify trends.
  • Experience with equipment IOPQ and Laboratory Training programs
 
 
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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