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Laboratory Manager, Quality Control

Accentuate Staffing is partnering with a global pharmaceutical company who is hiring for a Laboratory Manager of Quality Control. This is a direct hire opportunity, offering competitive pay and benefits, working onsite. The ideal candidate will have clearly demonstrated leadership experience and be highly knowledgeable in all aspects of Quality Control within a pharmaceutical manufacturing environment.

Responsibilities:

  1. Leading a team, responsible for all aspects of quality control within the facility consisting of 15-25 individuals.
  2. Managing individual contributors responsible for Quality Record management (OOSs, deviations, change controls, CAPAs), LIMS administration, Capital Project Management, Analytical Validation, Reference Standard Certification, and Stability Program management.
  3. Decision-maker on internal projects related to formulation, filling, environmental monitoring, facility improvements and developing new approaches to the business.
  4. Provide overall direction, activities and function as the authority and expert on chemistry and microbiology strategy, procedures and techniques, and regulatory compliance.

Requirements:

  1. BS in Chemistry, Biology, Microbiology or related Scientific field.
  2. 8 years of experience in a GMP regulated, pharmaceutical manufacturing environment.
  3. Clearly demonstrated management level and leadership experience.
  4. Knowledge of cGMP, GLP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines, body policies and procedures.


Job Requirements:
  • Monitor quality metrics for quality control
  • Performing various quality assurance and quality control testing
  • Ensure the quality control system
  • Review the quality-control results
  • Develop and control quality programs
  • Lead quality control and assurance programs
  • Submit quality control and safety inspection reports
  • Ensuring quality control testing/audit points
  • Understand and interpret quality control and quality assurance programs
  • Designing and implementing quality control standards
  • Develop and implement quality control training
  • Formulate, document and maintain quality control standards and on-going quality control objectives
  • Supervise internal and external quality control audits
  • Develop and implement overall quality control procedures
  • Develop and implement quality control training programs
  • Coordinate the quality control functions of contract
  • Assist with development of company quality control program
  • Ensure overall company compliance relating to quality control
  • Implement quality control training programs to key personnel
  • Report all quality control complaints and concerns
Posted
11/20/2021
Salary Range
$69,000.00 - 118,000.00
per Year
Salary range estimated by
Location
Raleigh, NC 27601, US