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Quality Assurance Specialist in Biopharma
2 months ago
Valspec, a leading global provider of system validation and lifecycle services, specializes in the commissioning and qualification of computerized systems for clients within the Life Sciences sector. Since its inception in 1999, Valspec has been dedicated 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 individuals who depend on its products. Numerous initiatives facilitate the availability of life-saving medications; others enhance production efficiency to meet market demands at reduced costs, paving the way for the discovery of groundbreaking 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 ensure that our offerings adhere to regulatory standards and 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 compliance with GxP, biopharma, and life sciences regulations.
- Conduct risk assessments and devise risk management plans to uphold product quality and safety.
- Review and endorse batch records, specifications, test methodologies, and other technical documentation to confirm 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 verify compliance with regulatory requirements.
- Investigate and address quality issues and non-conformances, implementing corrective and preventive measures.
- Prepare and submit regulatory filings and reports as mandated by regulatory bodies.
- Collaborate with cross-functional teams to initiate 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.
- Comprehensive understanding 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.
- Excellent communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams.
- Proven experience in conducting internal and external audits.
- Expertise in root cause analysis and the execution of corrective and preventive actions.
- Capacity to work independently and proactively while managing multiple tasks concurrently.
- Meticulous attention to detail and strong problem-solving capabilities.
If you are committed to quality and safety and wish to thrive in a dynamic, fast-paced environment alongside a team of dedicated professionals, we encourage you to consider this opportunity.
Valspec promotes 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 fostering a professional environment free from discrimination or harassment and are proud to maintain a Drug-Free Workplace.