Senior Quality Control Analytical Consultant

2 months ago


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

Senior Quality Control Analytical Consultant

KEY RESPONSIBILITIES

  • Effectively managing a team of analysts to conduct essential testing of products, raw materials, and environmental samples for biopharmaceutical sites and contract laboratories.
  • Ensuring adherence to quality control testing protocols in accordance with ICH and GMP standards as well as industry best practices.
  • Supervising the formulation and execution of sampling strategies for both internal facilities and contract manufacturers.
  • Designing sampling methodologies to support manufacturing processes while ensuring efficient and effective testing workflows.
  • Overseeing the development, review, and modification of specifications related to quality control testing.
  • Guaranteeing that both internal and external specifications align with health authority regulations.
  • Establishing and maintaining a comprehensive equipment maintenance program to facilitate necessary preventative maintenance and calibrations.
  • Ensuring all quality control testing instruments are calibrated and maintained in compliance with regulatory standards.
  • Ensuring the integrity of data generated and stored within the Quality Control framework.
  • Evaluating equipment and processes to ensure compliance with data integrity standards.
  • Providing expert consultation on data integrity matters to various departments within the organization.
  • Building and nurturing strong relationships with key stakeholders, both within and outside the organization.
  • Balancing the operational demands of internal sites with those of contract suppliers.
  • Guiding and mentoring emerging leaders by sharing knowledge and best practices.
  • Proactively identifying and addressing conflicts.
  • Establishing partnerships with external entities to remain at the forefront of industry advancements.
  • Promoting a culture that values innovative thinking and encourages creativity in quality control practices.
  • Addressing systemic challenges within the organization with integrity and determination.
  • Making informed decisions with respect, empathy, and integrity, while taking calculated risks when necessary.
  • Demonstrating credibility at the organizational level through visionary leadership and strategic decision-making.
  • Taking accountability for actions and decisions while achieving results aligned with quality objectives.
  • Creating opportunities for knowledge sharing and collaboration across various departments.
  • Leading organizational change initiatives by establishing a clear vision and direction.
  • Fostering a culture that embraces change and innovation in quality control practices.

QUALIFICATIONS

  • At least 10 years of experience in quality control within the biopharmaceutical or biotechnology sectors.
  • Comprehensive understanding of regulatory standards pertinent to quality control testing.
  • Exceptional leadership and interpersonal capabilities.
  • Strong communication and problem-solving skills.
  • Demonstrated success in driving innovation and change within quality control processes.

EDUCATION

  • Bachelor's or advanced degree in a relevant discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences).


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