QC Analytical Laboratory Manager

Published: April 29, 2021
Location
PR, Puerto Rico
Job Type
Category
Job Code
23865
Years of Experience
10
Salary
Commensurate with candidate experience.
Travel
No
Education
Bachelor’s Degree
Contact
Ilia Cordero
Contact Email
icordero@careersincpr.com

Description

Responsibilities:

  • Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities
  • Leads the implementation of Quality-related projects including metrics
  • Manages change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests
  • Reviews and approves raw materials and commodities including ERP approval
  • Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs
  • Qualification and validation protocol writing, review, and approval
  • Actively participates in Periodic Validation Reviews, Annual Product Reviews, internal audits, and process data reviews
  • Provides front room and laboratory SME support during regulatory agency and internal inspections

Requirements

•Bachelor’s degree with 10 years of pharmaceutical Quality experience (preferably in QC)

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