Quality Assurance Analyst II

1 week ago

Lexington, Kentucky, United States Genezen Full time
Job Overview

The gene therapy sector is expanding rapidly, and Genezen is dedicated to fulfilling the precise requirements of our clients. We specialize in process development, manufacture GMP viral vectors, and facilitate cell transduction for clinical trials in gene and cell therapy, proudly contributing to the advancement of new treatments.

WORKING AT GENEZEN

Many individuals have experienced workplaces where they feel like just another anonymous cog in a vast machine. Genezen stands apart. We seek employees who are innovative, collaborative problem solvers committed to addressing the challenges of a fast-growing organization. We are devoted to empowering our staff to reach their full potential, making Genezen a fulfilling place to work. Every team member plays a vital role in the company's success, and you can be part of that journey.

ROLE PURPOSE

The Quality Assurance Specialist II is responsible for supporting daily quality operations through active presence in the Manufacturing Clean Room, overseeing Material/Inventory QA Release, and managing all aspects of the Quality Management System (QMS). This includes, but is not limited to, handling deviations, Corrective and Preventive Actions (CAPAs), change control, batch review, data integrity, and training to support biologics manufacturing.

KEY RESPONSIBILITIES

  • Facilitate cGMP manufacturing and supply chain operations by administering and enforcing the Quality Management System, including deviations, change controls, and CAPAs.
  • Review and authorize batch records, solution lot records, and raw material release documentation.
  • Assist in internal and external audits.
  • Investigate and approve deviations related to supply chain and production processes.
  • Provide on-site QA support for production and supply chain activities.
  • Represent Quality Assurance in project teams and meetings.
  • Identify and implement enhancements to Quality Management System procedures to drive positive change with minimal supervision.
  • Perform additional duties as required.

QUALIFICATIONS AND SKILLS

  • A Bachelor's degree in Life Sciences or Engineering is required.
  • 2-6 years of relevant GMP experience in a pharmaceutical or biotechnology setting, working within a quality system and regulated GMP environment.
  • Strong knowledge of cGMP/ICH/FDA/EU regulations and guidelines.
  • Proficient in Microsoft Office applications (MS Word, MS Excel, MS PowerPoint).
  • Ability to lift 25 pounds and demonstrate aseptic gowning capabilities.

PHYSICAL REQUIREMENTS

While performing the duties of this position, the employee is expected to meet the following physical demands:

  • Occasional exposure to high noise levels.
  • Work may be a combination of remote and on-site.
  • Regularly sit for extended periods.

MOVEMENT

  • Frequently required to stand, sit, use hands for handling, and reach with arms.
  • Occasionally required to walk, climb, balance, stoop, kneel, crouch, or crawl.

LIFTING

  • Frequently lift and/or move up to 10 pounds.
  • Occasionally lift and/or move up to 25 pounds.

VISION

  • Frequently utilize close vision and the ability to adjust focus.

COMMUNICATION

  • Frequently required to communicate verbally and through written means.

GENEZEN'S CORE VALUES

Committed to Science: We prioritize scientific excellence, staying updated with industry advancements, making data-driven decisions, and pursuing innovation to enhance healthcare.

Urgency for Patients: We act with urgency and dedication to deliver timely treatments to patients by expediting our partners' programs.

Resilience in Operations: We are dedicated to overcoming challenges, learning from setbacks, and persistently striving for success.

Excellence & Integrity: We are committed to delivering quality outcomes while upholding ethical standards.

Solutions-Oriented: We aim to be proactive, collaborative, creative, and open-minded partners.

GENEZEN'S BENEFITS

  • Paid vacation days based on tenure.
  • Paid sick leave.
  • 9 observed holidays plus 1 floating holiday and 1 volunteer day.
  • 401(k) plan with company match up to 6% of salary, vested immediately.
  • Share Appreciation Rights.
  • Choice of multiple healthcare plans.
  • Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
  • Dental and vision coverage.
  • Employer-paid basic term life and personal accident insurance.
  • Voluntary disability and universal life/personal accident insurance.
  • Accidental Death & Dismemberment (AD&D) Insurance.

ADDITIONAL INFORMATION

  • Management reserves the right to assign or reassign duties and responsibilities to this position at any time.
  • This role requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • Genezen participates in E-Verify.
  • Genezen welcomes all qualified candidates eligible to work in the United States; however, we are unable to sponsor visas.

  • Quality Assurance Analyst II

    2 weeks ago

    Lexington, Kentucky, United States Genezen Full time

    Job OverviewThe field of gene therapy is expanding swiftly, and Genezen is committed to fulfilling the precise requirements of our clients. We specialize in process development, the production of GMP viral vectors, and cell transduction for gene and cell therapy clinical trials, playing a vital role in the journey towards new cures.WORKING AT GENEZENMany...

  • Quality Assurance Analyst II

    1 week ago

    Lexington, Kentucky, United States Genezen Full time

    Job OverviewThe realm of gene therapy is advancing swiftly, and Genezen is poised to address the precise requirements of our clientele. We specialize in process development, manufacture GMP viral vectors, and facilitate cell transduction for gene and cell therapy clinical trials, proudly contributing to the emergence of innovative cures.WORKING AT...

  • Quality Assurance Specialist II

    2 weeks ago

    Lexington, Kentucky, United States Randstad Life Sciences US Full time

    Contract PositionLocation: Lexington, MAPay Rate: $48-53/hrPosition OverviewThe primary responsibilities of this role will concentrate on the daily laboratory functions and the execution of assessments to support manufacturing processes, validation, or developmental studies. Testing may encompass, but is not limited to, samples from drug substance and drug...

  • Pharmaceutical Quality Assurance Specialist

    2 weeks ago

    Lexington, Kentucky, United States Zifo Full time

    Location: Lexington, MA – ON SITE**This role will require the successful candidate to be on-site in Lexington, MA****This role is not eligible for relocation assistance**Position Overview: Zifo is seeking a seasoned Quality Assurance Analyst with a strong background in the pharmaceutical sector. The ideal candidate will possess significant experience in...

  • Pharmaceutical Quality Assurance Specialist

    2 weeks ago

    Lexington, Kentucky, United States Zifo Full time

    Location: Lexington, MA – ON SITE**This role will require the successful candidate to be on-site in Lexington, MA****This role is not eligible for relocation assistance**Position Overview: Zifo is seeking a seasoned Quality Assurance Analyst with a strong background in the pharmaceutical sector. The ideal candidate will possess significant expertise in...

  • Information Security Assurance Analyst

    2 weeks ago

    Lexington, Kentucky, United States Digital Prospectors Full time

    Position: Information Security Assurance AnalystJob Type: ContractLocation: HybridJob Overview:Digital Prospectors is seeking an Information Security Assurance Analyst to evaluate, interpret, and execute information assurance and security engineering protocols.The Information Security Assurance Analyst will establish criteria for business continuity,...

  • Quality Assurance Manager

    6 days ago

    Lexington, Kentucky, United States Siemens Mobility, Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Siemens Mobility, Inc. As a key member of our operations, you will oversee a team of quality assurance professionals responsible for ensuring the highest standards of quality in our rail car manufacturing process.Key ResponsibilitiesDevelop and implement quality...

  • Quality Assurance Lead

    6 days ago

    Lexington, Kentucky, United States Siemens Mobility, Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Siemens Mobility, Inc. As a key member of our operations, you will oversee a team of quality assurance professionals responsible for ensuring the highest standards of quality in our rail car manufacturing process.Key ResponsibilitiesDevelop and implement quality...

  • Quality Assurance Engineer

    6 days ago

    Lexington, Kentucky, United States Bitwerx Inc Full time

    Job DescriptionAbout Bitwerx Inc.Bitwerx Inc. is a software development company that specializes in designing, building, and supporting innovative software solutions that leverage data to improve the customer journey. Our team of industry experts has extensive experience in various industries, including veterinary and dental, and we work with clients ranging...

  • Quality Assurance Specialist

    6 days ago

    Lexington, Kentucky, United States Zobility Full time

    We are seeking a Quality Assurance Specialist to join our team at Zobility, a workforce management and staffing division of RGBSI. As a Quality Assurance Specialist, you will be responsible for auditing and creating process gap lists to improve the quality of wiring harnesses.Key Responsibilities:Conduct on-site audits at client facilities to identify areas...

  • Quality Assurance Manager

    2 weeks ago

    Lexington, Kentucky, United States InsideHigherEd Full time

    Position Title:Quality Assurance ManagerDepartment:Kentucky Community Cancer ProgramLocation:RemoteSalary Range:$47,278 - $78,000/yearEmployment Type:Full-Time StaffRequired Education:Bachelor's DegreeExperience Required:5 years in relevant fieldsJob Overview:The Kentucky Cancer Registry (KCR) is seeking a Quality Assurance Manager to oversee the development...

  • Quality Assurance Manager

    1 week ago

    Lexington, Kentucky, United States InsideHigherEd Full time

    Position Title:Quality Assurance ManagerDepartment:Cancer Registry OperationsLocation:RemoteEmployment Type:Full-TimeEducation Required:Bachelor's DegreeExperience Required:5 years in relevant fieldsJob Overview:The Kentucky Cancer Registry is seeking a Quality Assurance Manager to spearhead the development and implementation of educational initiatives and...

  • Quality Assurance Manager

    1 week ago

    Lexington, Kentucky, United States InsideHigherEd Full time

    Position Title:Quality Assurance ManagerDepartment:Cancer Registry DivisionLocation:RemoteJob Type:Full-TimeEducation Required:Bachelor's DegreeExperience Required:5 years in relevant fieldsJob Overview:The Cancer Registry Division is seeking a Quality Assurance Manager to spearhead the development and implementation of educational and training initiatives,...

  • Quality Assurance Analyst

    2 weeks ago

    Lexington, Kentucky, United States Kindeva Drug DeliverySummit Biosciences Full time

    Job OverviewKindeva Drug Delivery is a prominent global contract developer and manufacturing organization (CDMO) renowned for its expertise in various delivery platforms, including Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. Our Lexington facility specializes in the development, manufacturing, and commercialization...

  • Quality Assurance Manager

    2 weeks ago

    Lexington, Kentucky, United States InsideHigherEd Full time

    Position Title:Quality Assurance ManagerRequisition Number:RE46319Department:Kentucky Community Cancer ProgramLocation:Remote/HybridSalary Range:$47,278-78,000/yearEmployment Type:Full-Time StaffEducational Requirements:Bachelor's DegreeExperience Required:5 years in relevant fieldsJob Overview:The Kentucky Cancer Registry (KCR) is seeking a Quality...

  • Quality Assurance Analyst

    1 week ago

    Lexington, Kentucky, United States Kindeva Drug DeliverySummit Biosciences Full time

    Job OverviewKindeva Drug Delivery is a prominent global contract developer and manufacturing organization (CDMO) specializing in advanced delivery platforms, including Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. Our Lexington facility is dedicated to the development, manufacturing, and commercialization of...

  • Quality Assurance Analyst

    1 week ago

    Lexington, Kentucky, United States Kindeva Drug DeliverySummit Biosciences Full time

    Job OverviewKindeva Drug Delivery is a prominent global contract developer and manufacturing organization (CDMO) renowned for its expertise in various delivery platforms, including Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. Our Lexington facility is dedicated to the development, manufacturing, and commercialization...

  • Quality Assurance Manager

    2 weeks ago

    Lexington, Kentucky, United States InsideHigherEd Full time

    Position Title:Quality Assurance ManagerDepartment:Kentucky Community Cancer ProgramLocation:Remote Work AvailableEmployment Type:Full-TimeEducation Required:Bachelor's DegreeExperience Required:5 years in relevant fieldsJob Overview:The Kentucky Cancer Registry is seeking a Quality Assurance Manager to oversee the development and implementation of...

  • Quality Assurance Manager

    1 week ago

    Lexington, Kentucky, United States InsideHigherEd Full time

    Position Title:Quality Assurance Manager/Abstract & TrainingDepartment:Kentucky Community Cancer ProgramLocation:RemoteSalary Range:$47,278 - $78,000/yearEmployment Type:Full-Time StaffRequired Qualifications:Bachelor's Degree with a minimum of 5 years of relevant experience in nursing, medical coding, or Health Information Management.Job Overview:The...

  • Heroic Quality Assurance Specialist

    1 week ago

    Lexington, Kentucky, United States idktest231 Full time

    Job OverviewWe are seeking a dedicated and detail-oriented Quality Assurance Specialist to join our dynamic team at idktest231. This role is crucial in ensuring that our products meet the highest standards of quality and performance.Duties & ResponsibilitiesConduct thorough testing of software applications to identify defects and ensure optimal...