Quality Control Scientist

3 weeks ago

East Brunswick, United States Kaztronix LLC Full time

Summary/Objective

This position is responsible for ensuring compliance with Good Manufacturing Practices (GMP) regulations and maintaining the highest quality standards in all laboratory operations. This role involves overseeing laboratory quality programs, conducting internal audits, ensuring operation adherence to regulatory guidelines, and leading continuous improvement initiatives within the laboratory. The ideal candidate will have a strong background in chemistry or biology and possess extensive experience in quality management within a GMP-compliant environment.


ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

  • GMP Compliance:
  • Ensure that laboratory activities comply with GMP regulations, as well as other applicable regulatory requirements (FDA, EMA, etc.).
  • Develop, implement, and maintain GMP policies and procedures across the laboratory.
  • Oversee quality control measures to ensure the accuracy, precision, and reliability of laboratory data.
  • Quality Assurance Program:
  • Lead the development, implementation, and maintenance of the laboratory Quality Program.
  • Conduct internal audits of laboratory processes to ensure compliance with GMP and identify areas for improvement.
  • Collaborate with cross-functional teams to ensure quality standards are integrated into laboratory operations.
  • Training and Education:
  • Develop and conduct GMP training programs for laboratory staff, ensuring laboratory personnel understand and comply with quality standards.
  • Keep staff informed of updates to GMP regulations and industry best practices.
  • Document Control and Management:
  • Oversee the creation, review, and approval of all GMP-related documents, including Standard Operating Procedures (SOPs), protocols, and test procedures.
  • Ensure proper documentation of deviations, investigations, and corrective/preventive actions (CAPAs).
  • Risk Management:
  • Identify and assess quality risks related to laboratory operations and implement mitigation strategies.
  • Lead investigations into quality issues and implement corrective actions to prevent recurrence.
  • Continuous Improvement:
  • Lead continuous improvement initiatives focused on enhancing laboratory quality and compliance.
  • Monitor and report key quality metrics to senior management, driving a culture of quality throughout the organization.
  • External Audits and Regulatory Inspections:
  • Prepare the laboratory for audits, audit responses, and ensure timely resolution of any findings.


QUALIFICATIONS:

Education:

  • Bachelor's degree in Chemistry, Biology, or a related scientific field is required.

Certifications (Preferred):

  • ASQ Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or equivalent certification.
  • GxP compliance training and certification.


Experience:

  • Minimum of 5 years of experience in quality management within a GMP compliant environment, preferably in the pharmaceutical or biotechnology industries.
  • Experience in GMP quality reviews preferred
  • Audit experience required
  • Strong background in chemistry or biology, with a thorough understanding of laboratory operations and regulatory requirements.


OTHER SKILLS, ABILITIES OR QUALIFICATIONS

Skills and Competencies:

  • In-depth knowledge of GMP regulations and their application in laboratory.
  • Strong leadership and managerial skills, with experience in managing teams and driving quality initiatives.
  • Excellent organizational skills with attention to detail and the ability to manage multiple projects simultaneously.
  • Strong problem-solving and decision-making abilities.
  • Excellent communication skills, both written and verbal, with the ability to effectively communicate quality issues to laboratory staff and senior management.
  • Proficiency in quality management software and Microsoft Office Suite.

Work Environment

  • This position will primarily be based in a laboratory setting, with occasional office work for documentation and meetings.
  • The role requires strict adherence to safety protocols and the use of personal protective equipment (PPE) as needed.

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