Quality Assurance Specialist in Biopharma

2 weeks ago

College Station, Texas, United States Valspec Full time
Job Overview

Valspec—a global leader in system validation and lifecycle services—focuses on the commissioning and qualification of computerized systems for clients within the Life Sciences sector. Since its inception in 1999, Valspec has dedicated itself to delivering a comprehensive range of services that assist clients in achieving their capital project and lifecycle maintenance objectives.

The projects undertaken by Valspec are vital to the industry and to the individuals who depend on its offerings. Numerous initiatives ensure that transformative medications are accessible to those in need, while others enhance production efficiency to meet demand at reduced costs, paving the way for the discovery of groundbreaking therapies.

Quality Assurance / Quality Control Engineer (GxP, Biopharma, and Life Sciences) - Focus on Cell and Gene Therapy

We are in search of a knowledgeable Quality Assurance / Quality Control Engineer to ensure that our offerings comply with regulatory standards and surpass client expectations. The ideal candidate will possess a deep understanding of GxP, biopharma, and life sciences regulations, providing essential technical support to guarantee the quality and safety of our cell and gene therapy products.

Key Responsibilities:

  • Formulate and execute quality assurance and control strategies for cell and gene therapy products in alignment with GxP, biopharma, and life sciences regulations.
  • Conduct risk assessments and devise risk management plans focused on product quality and safety.
  • Evaluate and endorse batch records, specifications, testing methodologies, and other technical documents to ensure adherence to regulatory standards.
  • Offer technical assistance to manufacturing, analytical, and quality control teams to ensure products meet established quality benchmarks.
  • Perform internal and external audits of facilities, systems, and processes to confirm compliance with regulatory mandates.
  • Investigate and rectify quality concerns and non-conformances, implementing corrective and preventive measures.
  • Prepare and submit regulatory documentation and reports as mandated by regulatory bodies.
  • Collaborate with cross-functional teams to create and implement quality enhancement initiatives.
  • Stay informed about regulatory changes and industry best practices, communicating updates to relevant stakeholders.

Qualifications and Requirements:

  • Bachelor's or Master's degree in a scientific field, ideally in biology, biochemistry, or biotechnology.
  • A minimum of 5 years of experience in quality control or quality assurance within a GxP regulated environment, preferably in biopharma or cell and gene therapy.
  • Extensive knowledge of GxP, biopharma, and life sciences regulations, particularly FDA and EMA guidelines, along with experience in regulatory compliance and submissions.
  • Experience in the development and validation of analytical methods.
  • Strong communication and interpersonal skills, with the ability to work collaboratively across various teams.
  • Experience in conducting internal and external audits.
  • Proficiency in root cause analysis and the implementation of corrective and preventive actions.
  • Capability to work independently and proactively, managing multiple tasks concurrently.
  • Meticulous attention to detail and robust problem-solving abilities.

If you are dedicated to quality and safety and wish to thrive in a dynamic, fast-paced environment alongside a team of skilled and committed professionals, we encourage you to consider this exciting opportunity.

Valspec fosters a distinctive culture, offers an exceptional work environment, and provides competitive benefits, including premium medical coverage, 401K matching, profit sharing, tuition reimbursement, and other unique incentives.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status, or any other protected class. We are committed to maintaining a professional environment free from discrimination or harassment and take pride in being a Drug-Free Workplace.

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