About the position
The Technical Reviewer in LGC AxoLabs Quality Control is a dual role with no less than 70% focus on reviewer and document generation responsibilities. The remaining time will be spent in support of analytical testing in the laboratory. This role will be responsible for reviewing documents and source data to ensure accuracy, completeness and integrity following the principles of ALCOA+. This role involves review and generation of testing, reporting, and investigation data and documentation working with cross-functional teams to ensure accurate and timely support of in-process, release and stability testing of oligonucleotide API and raw materials in compliance with regulatory standards to ensure the safety and consistency of products. We have an extensive, ever-evolving global client base along with impressive technical capabilities within a state-of-the-art GMP facility. As needs for the organization continue to evolve, we are looking for driven candidates who can grow with the organization. The successful candidate will be detail-oriented, proficient in review of analytical data for quality control, educated in analytical chemistry techniques, and have (or gain) experience in oligonucleotide analysis. The Technical Reviewer will work under the supervision of the QC Manager and collaborate directly with QC scientists to achieve timely corrections and delivery of results to internal and external stakeholders. Routine tasks include review of analytical data and laboratory notebooks for LC-MS, KF, GC, Endotoxin and other analytical methods. Review and creation of CoAs, reports, and deviation investigations for release and stability results. Individuals may also perform sample testing for in-process manufacturing support, release of raw materials and investigation as required to maintain project timelines.
Responsibilities
- Review documents and source data to ensure accuracy, completeness, and integrity following ALCOA+ principles.
- Generate testing, reporting, and investigation data and documentation.
- Collaborate with cross-functional teams to support in-process, release, and stability testing of oligonucleotide API and raw materials.
- Review analytical data and laboratory notebooks for various analytical methods including LC-MS, KF, GC, and Endotoxin.
- Create Certificates of Analysis (CoAs), reports, and deviation investigations for release and stability results.
- Perform sample testing for in-process manufacturing support and release of raw materials as required.
Requirements
- Bachelor’s degree in Chemistry or the Life Sciences.
- 5+ years of industry experience or proficiency as a Quality Control Reviewer.
- Minimum of 3 years working in a GMP laboratory setting including OOX investigation experience.
- Strong knowledge of organic chemistry and/or analytical chemistry.
- Proficiency in analytical techniques such as HPLC, LC-MSMS, GC-MS, KF, FT-IR.
- Solid teamwork skills to interface with engineers, chemists, technicians, and analysts.
- Proficient in cGMP.
- Working knowledge of chromatography software including Empower, MassLynx, Chromeleon, and/or Waters Connect.
- Prior experience in a CMO/CDMO manufacturing environment and understanding of ICH guidelines and data integrity requirements.
Nice-to-haves
- Good written and oral communication skills.
Benefits
- Competitive compensation with strong bonus program.
- Comprehensive medical, dental, and vision benefits for employees and dependents.
- FSA/HSA Pre-tax savings plans for health care, childcare, and elder care.
- Deductible Buffer Insurance and Critical Illness Insurance.
- 401(k) retirement plan with matching employer contribution.
- Company-paid short- and long-term disability, life insurance, and employee assistance program.
- Flexible work options.
- Pet Insurance for our furry friends.
- Enhanced Parental leave of 8 additional weeks.
- PTO that begins immediately.
- Town Hall monthly meeting onsite/virtual.
- Cheer program where employees are recognized for outstanding work.
- Company-wide social events, frequent catered lunches, and much more!
