Quality Assurance Specialist in Biopharma

1 week ago

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

Valspec—a leading global provider of system validation and lifecycle services—specializes in the commissioning and qualification of computerized systems tailored 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, facilitating the exploration of novel and innovative therapies.

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

We are in search of a seasoned Quality Control / Quality Assurance Engineer to uphold the standards of our products in accordance with regulatory mandates and to surpass client expectations. The ideal candidate will possess extensive expertise in 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 control and assurance strategies for cell and gene therapy products, ensuring adherence to GxP, biopharma, and life sciences regulations.
  • Conduct risk assessments and devise risk management plans to safeguard product quality and safety.
  • Review and validate batch records, specifications, test methodologies, and other technical documentation to ensure regulatory compliance.
  • Offer technical assistance to manufacturing, analytical, and quality control teams to ensure products meet established quality standards.
  • Perform internal and external audits of facilities, systems, and processes to verify compliance with regulatory requirements.
  • Investigate and resolve quality-related issues and non-conformances, implementing corrective and preventive measures.
  • Prepare and submit necessary regulatory filings and reports as mandated by regulatory authorities.
  • Collaborate with cross-functional teams to develop and execute quality enhancement initiatives.
  • Stay informed on regulatory requirements 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.
  • Comprehensive knowledge of GxP, biopharma, and life sciences regulations, particularly FDA and EMA standards, along with experience in regulatory compliance and submissions.
  • Proficiency in analytical methods development and validation.
  • Strong communication and interpersonal skills, with the ability to work collaboratively across diverse teams.
  • Experience in conducting internal and external audits.
  • Expertise in root cause analysis and the implementation of corrective and preventive actions.
  • Ability to work autonomously and proactively, managing multiple priorities simultaneously.
  • Meticulous attention to detail and robust problem-solving capabilities.

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

All candidates must be legally authorized to work in the United States without company sponsorship. Additionally, we are not currently engaging in corp-to-corp arrangements with other entities.

Any unsolicited resume submissions from third parties will become the property of Valspec. Valspec will not compensate any employment agency, individual, or entity for submissions unless a signed agreement is in place.

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 dedicated to maintaining a professional environment free from discrimination or harassment and take pride in being a Drug-Free Workplace.

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