Agency Temporary Specialist, QC Analytical

NantWorks (the “Company”) is the parent company of various private and public entities that are changing how we work, live and play. We focus on three main categories: life sciences; energy & renewables; and media & technology. We invest in strategies that improve our core capabilities and in brand new industries, poised to change mankind for the better. By capturing tomorrow’s opportunities through scientific processes and entrepreneurial philosophies, we are at the forefront of emerging high-growth technologies across a wide range of industries.

The Company is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. The Company may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.

Position Summary

The Agency Temporary - Specialist, QC Analytical will serve as Subject Matter to advise contract testing laboratories on method development, method validation, method transfer, and quality investigations. Primary duties will include data review and troubleshooting of analytical test methods.

Essential Functions

Author, review and revise documentation (SOPs, test methods, analytical method development, method validation, method transfer protocols/ reports, product specifications)

Review QC stability and lot release data (data integrity check) and CoAs issued by contract testing laboratories and create batch release certificate of analysis

Author and review laboratory OOS investigation and invalid laboratory test result, including filing internal Quality Systems reports as applicable

Author, review and revise Analytical Section of documents such as the IND, BLA for regulatory CMC submission

Provide technical expertise to troubleshoot analytical methods

Mange suppliers change notifications and change controls

Generate Purchase Requests and Purchase Orders for contract testing laboratories projects

Ensure timely escalation of quality control related issues

Assist QC-Analytical management in tracking and trending data

Collaborate with other departments (e.g. QA and Regulatory) for quality control related duties

Attend QC-Analytical internal meetings and external meetings with contract testing laboratories

May conduct other duties, as assigned

Education & Experience

Bachelor's degree with 8+ years relevant experience in Analytical Chemistry or related discipline required; or

Master's degree with 6+ years of experience in Analytical Chemistry or related discipline required.

Experience in method development, method validation, method transfer, lot release tests, stability programs and specification development required

Knowledge, Skills, & Abilities

Strong knowledge of quality control analytical method development, method validation and method transfer

Strong technical writing skills to author SOPs, analytical tests methods, qualification/validation protocols/ reports

Knowledge and understanding of USP, EP and ICH guidelines

In-depth knowledge of GMPs and pharmaceutical regulations

Ability to communicate effectively with internal functions both in writing and verbally

Ability to collaborate with contract testing laboratories, consultants, ensuring compliance with company procedures

Ability to multi-task and prioritize

Strong problem solving

Strong computer skills

Working Environment / Physical Environment

This position will work on hybrid (combination on site and remote) in El Segundo, CA

Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

$44.69 (entry-level qualifications) to $49.65 (highly experienced) per hour

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

This is the pay range the Company reasonably expects to pay for this position at the time of this posting. Compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position.

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