Senior Quality Control Specialist

3 days ago

Angleton, Texas, United States a Biopharmaceutical company located in TX Full time
Job Title: Sr. Analytical QC Consultant

At our Biopharmaceutical company in TX, we are seeking a highly skilled Sr. Analytical QC Consultant to join our team.

Responsibilities:
  • Lead a team of analysts in performing product, raw material, and environmental testing for our company sites and contract manufacturers and laboratories.
  • Ensure quality control testing processes comply with ICH and GMP regulatory requirements and industry best practices.
  • Oversee the design and implementation of sampling plans for internal sites and contract manufacturers.
  • Develop sampling plans to support manufacturing and ensure efficient and effective testing processes.
  • Coordinate the creation, review, and revision of specifications for quality control testing.
  • Ensure internal and external specifications are aligned and meet health authority requirements.
  • Establish and maintain an equipment maintenance program to support required preventative maintenance and calibrations.
  • Ensure all instruments used in quality control testing are calibrated and maintained according to regulatory requirements.
  • Ensure data is generated and stored to maintain integrity within Quality Control.
  • Assess equipment and processes for data integrity compliance.
  • Provide expert guidance on data integrity to other parts of the company.
  • Build strong relationships with key stakeholders, both internal and external.
  • Balancing the demands of internal sites with contract suppliers.
  • Mentor emerging leaders by sharing insights and best practices.
  • Proactively identify and resolve conflicts.
  • Partner with external organizations to stay at the forefront of industry trends.
  • Foster an environment that values creative thinking and encourages innovation in quality control processes.
  • Address systemic issues within the business with integrity and determination.
  • Make tough decisions with integrity, respect, and empathy for others, taking calculated risks when necessary.
  • Demonstrate credibility at the organizational level through visionary leadership and strategic decision-making.
  • Take ownership of actions and decisions while delivering results in line with quality objectives.
  • Create platforms for knowledge exchange and collaboration across departments.
  • Drive organizational change initiatives by setting a clear vision and direction.
  • Cultivate a culture that embraces change and innovation in quality control processes.
Qualifications:
  • Minimum 10+ years of experience in quality control within the pharmaceutical or biotechnology industry.
  • Thorough understanding of regulatory requirements related to quality control testing.
  • Strong leadership and interpersonal skills.
  • Excellent communication and problem-solving abilities.
  • Proven track record of driving change and innovation in quality control processes.
Education:
  • Bachelor's or advanced degree in a relevant field (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences).

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