Quality Engineer
2 months ago
Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.
Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.
Quality Control / Quality Assurance Engineer (GxP, Biopharma, and Life Sciences) - Cell and Gene Therapy
We are seeking an experienced Quality Control / Quality Assurance Engineer to join our team and ensure that our products meet regulatory requirements and exceed customer expectations. The successful candidate will have extensive knowledge of GxP, biopharma, and life sciences regulations and will provide technical support to ensure the quality and safety of our cell and gene therapies.
Key Responsibilities:
- Develop and implement quality control and assurance strategies for cell and gene therapy products in compliance with GxP, biopharma, and life sciences regulations
- Perform risk assessments and develop risk management plans for product quality and safety
- Review and approve batch records, specifications, test methods, and other technical documents to ensure compliance with regulatory requirements
- Provide technical support to manufacturing, analytical, and quality control teams to ensure that products meet quality standards
- Conduct internal and external audits of facilities, systems, and processes to ensure compliance with regulatory requirements
- Investigate and resolve quality issues and non-conformances and implement corrective and preventive actions
- Prepare and submit regulatory filings and reports as required by regulatory authorities
- Collaborate with cross-functional teams to develop and implement quality improvement initiatives
- Keep up-to-date with regulatory requirements and industry best practices and communicate changes and updates to the relevant stakeholders
Qualifications and Requirements:
- Bachelor's or Master's degree in a scientific discipline, preferably in biology, biochemistry, or biotechnology
- At least 5 years of experience in quality control or quality assurance in a GxP regulated environment, preferably in biopharma or cell and gene therapy
- Strong knowledge of GxP, biopharma, and life sciences regulations, particularly FDA and EMA regulations, and experience in regulatory compliance and filings
- Experience in analytical methods development and validation • Strong communication and interpersonal skills, and ability to collaborate effectively with cross-functional teams
- Experience in conducting internal and external audits
- Experience in root cause analysis and implementation of corrective and preventive actions
- Ability to work independently and proactively, and manage multiple tasks simultaneously
- Attention to detail and strong problem-solving skills
If you are passionate about quality and safety, and want to work in a fast-paced, dynamic environment with a team of talented and committed professionals, we encourage you to apply for this exciting opportunity.
Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.
Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.
Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.
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 providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
-
Quality Assurance Engineer
2 weeks ago
College Station, Texas, United States Jobot Full timeQuality Assurance Engineer sought for a leading manufacturer in the solar energy sector This opportunity is hosted by Jobot. A brief overview of our company: We take pride in being a leader in the solar energy market, producing high-efficiency solar modules and offering comprehensive services that align with industry standards. Our innovative manufacturing...
-
Quality Assurance Engineer
1 week ago
College Station, Texas, United States Valspec Full timeJob OverviewValspec, a leading provider of system validation and lifecycle services, specializes in the commissioning and qualification of computerized systems within the Life Sciences sector. Our commitment since 1999 has been to deliver a comprehensive range of services that empower our clients to achieve their capital project and lifecycle maintenance...
-
Quality Assurance Engineer
1 week ago
College Station, Texas, United States Valspec Full timeJob OverviewValspec, a renowned global provider of system validation and lifecycle services, specializes in the commissioning and qualification of computerized systems within the Life Sciences sector. Our mission is to deliver a comprehensive range of services that assist clients in achieving their capital project and lifecycle maintenance objectives.The...
-
Quality Assurance Engineer
1 week ago
College Station, Texas, United States Valspec Full timeJob OverviewValspec, a leading 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...
-
Quality Assurance Engineer
7 days ago
College Station, Texas, United States Salent Solutions Full timeJob OverviewSalent Solutions is seeking a highly skilled CQV Engineer to join our team. As a CQV Engineer, you will play a critical role in ensuring that all systems, facilities, and equipment are installed properly and meet the design requirements for pharmaceutical facilities.Key Responsibilities:Ensure that all systems, facilities, and equipment are...
-
Quality Assurance Validation Engineer
2 weeks ago
College Station, Texas, United States Valspec Full timeJob OverviewValspec, a prominent global provider of system validation and lifecycle services, is dedicated to delivering commissioning and qualification of computerized systems for clients within the Life Sciences sector. Our mission, established in 1999, is to offer a comprehensive range of services that assist our clients in achieving their capital project...
-
Chemist
4 days ago
College Station, Texas, United States First Quality Full timeJob SummaryWe are seeking an experienced Chemist to join our team at First Quality, a leading manufacturer of consumer products. As a key member of our quality assurance team, you will be responsible for implementing, maintaining, and improving our quality systems to ensure the highest standards of product quality.Key ResponsibilitiesQuality System...
-
Quality Compliance Investigator
2 weeks ago
College Station, Texas, United States Medix™ Full timePosition: Deviation InvestigatorKey Responsibilities:Perform thorough investigations into process deviations, procedural anomalies, and nonconforming incidents.Ensure comprehensive analysis of root causes, corrective actions, and preventative measures (CAPA), along with assessing product impact during investigations.Compile and document findings from...
-
Quality Assurance Investigator
2 weeks ago
College Station, Texas, United States Medix™ Full timePosition: Deviation InvestigatorKey Responsibilities:Conduct thorough investigations into process deviations, procedural anomalies, and nonconformance incidents.Ensure comprehensive analysis of root causes, corrective actions, and preventive measures (CAPA), along with assessment of product impact.Compile and document findings from investigations.Design,...
-
Quality Assurance Investigator
2 weeks ago
College Station, Texas, United States Medix™ Full timePosition Title: Deviation InvestigatorKey Responsibilities:Conduct thorough investigations into process deviations, procedural anomalies, and nonconforming incidents.Ensure that root cause analysis, corrective actions, and preventative measures (CAPA) are comprehensively addressed in all investigations. Formulate actionable recommendations based on...
-
Automation Quality Assurance Specialist
2 weeks ago
College Station, Texas, United States BioPharma Consulting JAD Group Full timeAutomation Quality Assurance SpecialistAt BioPharma Consulting JAD Group, we are expanding our Automation division and are in search of talented Automation Quality Assurance Specialists. In this pivotal role, you will be responsible for delivering technical and operational assistance, executing essential projects, and overseeing automation systems to drive...
-
Automation Quality Assurance Specialist
2 weeks ago
College Station, Texas, United States BioPharma Consulting JAD Group Full timeAutomation Quality Assurance Specialist - BioPharma Consulting JAD GroupAt BioPharma Consulting JAD Group, we are expanding our Automation division and are in search of proficient Automation Quality Assurance Specialists. In this pivotal role, you will be instrumental in delivering technical and operational assistance, executing essential projects, and...
-
Head of Controls Engineering
2 weeks ago
State College, Pennsylvania, United States First Quality Full timeCompany Overview: First Quality is a global leader in the manufacturing of consumer products, with a strong commitment to quality and safety. Established in 1989, we have expanded our operations significantly, employing over 4,000 individuals across various locations.Position Summary: We are seeking a seasoned Director of Controls Engineering to oversee our...
-
Compliance Investigator
7 days ago
College Station, Texas, United States Azzur Group Full timeJob DescriptionAzzur Group is seeking a highly skilled Compliance Investigator to join our team. As a Compliance Investigator, you will play a critical role in ensuring the company's adherence to regulatory requirements and industry standards.Key Responsibilities:Investigations and Root Cause Analysis: Conduct thorough investigations into process excursions,...
-
Director Controls Engineering
2 months ago
State College, United States First Quality Full timeFirst Quality was founded in 1989 and, in nearly three decades, has grown to be a global privately held company with over 4,000 employees. Its corporate offices are located in Great Neck, New York, with manufacturing facilities and offices in Pennsylvania, South Carolina, Georgia, and Canada. First Quality is a diversified family of companies manufacturing...
-
Head of Controls Engineering
2 weeks ago
State College, Pennsylvania, United States First Quality Full timeCompany Overview: First Quality is a global leader in the manufacturing of consumer products, established in 1989. With a workforce exceeding 4,000 employees, our corporate headquarters is situated in Great Neck, New York, alongside multiple manufacturing facilities across various states and Canada. Our diverse portfolio includes products in Absorbent...
-
Quality Assurance Specialist
7 days ago
College Station, Texas, United States Jobot Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Jobot, a leading solar energy manufacturing industry leader. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and processes.Key ResponsibilitiesDevelop and Implement Quality Assurance ProtocolsDesign and...
-
Quality Assurance Specialist
2 weeks ago
College Station, Texas, United States Jobot Full timeQuality Assurance Specialist needed for a leading manufacturer in the solar energy sector.This position is hosted by Jobot, a proud American company at the forefront of the solar energy industry.Our advanced manufacturing facility produces high-efficiency solar modules, recognized for their excellence, and provides comprehensive services to comply with...
-
Quality Assurance Specialist
2 weeks ago
College Station, Texas, United States Jobot Full timeQuality Assurance Specialist needed for a leading company in the solar energy manufacturing sector.About Us:We are a proud American manufacturer, recognized as a leader in the solar energy field. Our cutting-edge production facility is dedicated to creating high-efficiency solar modules, ensuring compliance with the IRS' US-domestic production ITC adder...
-
Quality Assurance Specialist in Biopharma
1 week ago
College Station, Texas, United States Valspec Full timeJob OverviewValspec, 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...