Sr. Analytical QC Consultant

2 weeks ago


Angleton TX United States a Biopharmaceutical company located in TX Full time

Sr. Analytical QC Contractor

RESPONSIBILITIES

  • Strategically coordinating a team of analysts to perform necessary product, raw material, and environmental testing for company sites and contract manufacturers and laboratories.
  • Ensuring that quality control testing processes comply with ICH and GMP regulatory requirements and industry best practices.
  • Overseeing the design and implementation of sampling plans for internal sites and contract manufacturers.
  • Developing sampling plans to support manufacturing and ensuring efficient and effective testing processes.
  • Coordinating the creation, review, and revision of specifications for quality control testing.
  • Ensuring internal and external specifications are aligned and meet health authority requirements.
  • Creating and maintaining an equipment maintenance program to support required preventative maintenance and calibrations.
  • Ensuring all instruments used in quality control testing are calibrated and maintained according to regulatory requirements.
  • Ensuring data is generated and stored to maintain integrity within Quality Control.
  • Assessing equipment and processes for data integrity compliance.
  • Providing expert guidance on data integrity to other parts of the company.
  • Establishing strong relationships with key stakeholders, both internal and external.
  • Balancing the demands of internal sites with contract suppliers.
  • Mentoring emerging leaders by sharing insights and best practices.
  • Proactively identifying and resolving conflicts.
  • Building partnerships with external organizations to stay at the forefront of industry trends.
  • Fostering an environment that values creative thinking and encourages innovation in quality control processes.
  • Addressing systemic issues within the business with integrity and determination.
  • Making tough decisions with integrity, respect, and empathy for others, taking calculated risks when necessary.
  • Demonstrating credibility at the organizational level through visionary leadership and strategic decision-making.
  • Taking ownership of actions and decisions while delivering results in line with quality objectives.
  • Creating platforms for knowledge exchange and collaboration across departments.
  • Driving organizational change initiatives by setting a clear vision and direction.
  • Cultivating 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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