Technical Reviewer- Quality ControlCMC Analytical

The Technical Reviewer in LGC AxoLabs Quality Control is a hybrid 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 crossfunctional teams to ensure accurate and timely support of inprocess 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 everevolving global client base along with impressive technical capabilities within a stateoftheart 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 detailoriented 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 LCMS 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 inprocess manufacturing support release of raw materials and investigation as required to maintain project timelines.

Qualifications :

• Bachelors degree in Chemistry or the Life Sciences 5 years of industry experience and/or demonstrates proficiency to meet the requirements of a Quality Control Reviewer.
• 3year minimum working in a GMP laboratory setting including OOX investigation experience.

• Must have strong organic chemistry and/or analytical chemistry knowledge and proficiency in associated analytical techniques; HPLC LCMSMS or GCMS KF FTIR.
• Must have solid teamwork skills to interface with engineers chemists technicians and analysts to ensure smooth laboratory and plant operations.
• Proficient in cGMP.

• Working knowledge of chromatography software including Empower MassLynx Chromeleon and/or Waters Connect.
• Prior experience working in a CMO/CDMO manufacturing environment and understanding of ICH guidelines Data integrity requirements and other regulatory requirements a plus.
• Good written and oral communication skills.

Additional Information :

What we offer (US basedemployees):

• Competitive compensation with strong bonus program
• Comprehensive medical dental and vision benefits for employees and dependents
• FSA/HSA Pretax savings plans for health care childcare and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Companypaid 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!

The typical pay range for this role is:

Minimum: $ 74600 /Annual

Maximum: $ 123300 /Annual

This range represents the low and high end of the anticipated salary range for the California based position.  The actual base salary will depend on several factors such as: experience skills and location.

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age disability race color ethnic or national origin sex sexual orientation gender reassignment marital or civil partnership pregnancy or maternity religion or belief. Short listing interviewing and selection will always be carried out without regard to gender sexual orientation marital status color race nationality ethnic or national origins religion or belief age or trade union membership.

For more information about LGC please visit our website

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