QC Technical Services Analyst II/III

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Genezen
Lexington, VIRGINIA, United States
  • Environmental
  • FullTime
  • Applications have closed

JOB SUMMARY

The individual in this role will work collaboratively with the analytical development, quality control, and quality assurance teams to support successful transfer and implementation of QC analytical methods for the testing of viral vectors and gene therapy products in support of Genezen’s services and commercial products. The role includes executing assays, training personnel, managing materials, and generating documentation in compliance with cGMP standards and regulatory guidelines. Additionally, the role contributes to critical material and method lifecycle management and documentation.

ESSENTIAL JOB FUNCTIONS

Method Technology Transfer

  • Support the implementation and technology transfer of QC analytical methods, including assay execution, personnel training, procurement of materials and reagents, documentation generation, and facilitation of knowledge transfer.
  • Execute Performance Qualification (PQ) activities for new equipment.
  • Compile and analyze data to support tech transfer and method implementation.
  • Draft and revise equipment operational SOPs and method SOPs/worksheets in accordance with cGMP.
  • Receive training on new analytical methods and support assay execution during tech transfer.
  • Conduct QC Operations training for new methods and equipment.
  • Manage Bill of Materials (BOM) creation and coordinate procurement for tech transfer activities.

Critical Material Management

  • Lead inventory maintenance of critical materials, including freezer mapping and QC handoffs.
  • Support lifecycle management of critical materials, including qualification/re-qualification and COA review and generation.
  • Assist with data trending and compilation of trend reports.

Method Life Cycle and Documentation

  • Support drafting of protocols and reports for QC method transfer, qualification, verification, and validation.

  • Review, revise, and maintain procedures, including protocols and technical reports.

  • Assist in lifecycle maintenance of laboratory procedures and SOP updates.

  • Support QMS related activities by generating documentation to support change controls/deviations/investigations in eDMS systems.

  • Assist in assay troubleshooting and support continuous improvement initiatives.

SPECIAL JOB REQUIREMENTS

  • Adaptability required as work schedule may change based on business needs
  • Criminal background check required
  • Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

|———————————————————————————————————————-|———————–|
| EDUCATION / CERTIFICATIONS / LICENSES | Essential/Desired |
| BS or higher degree in Biology, Biochemistry, Molecular Biology or related Life Sciences | Essential |
| ON-THE-JOB EXPERIENCE | |
| 5+ years of relevant industry experience in QC | Essential |
| 2+ years of relevant experience with gene Therapy/Viral vector production | Desired |
| SKILLS / ABILITIES | |
| Experience with laboratory techniques (qPCR, ddPCR, ELISA, cell based assays etc.) | Desired |
| Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.) | Essential |
| Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential | Essential |
| Ability to work in a fast-paced, collaborative environment, and able to manage workload based on changing priorities | Desired |
| Experience with technical writing skills such as protocol, reports, procedures etc. | Desired |
| Good/effective communication and organizational skills with the ability to work well with others and independently | Essential |
| Ability to work collaboratively with cross functional departments | Essential |

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

  • Regularly sit for long periods of time

Movement

  • Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

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

Vision

  • Frequently required to communicate by talking, hearing, using telephone and e-mail
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