Quality Assurance Specialist II

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science.

Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA.

You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

Position Summary

The Quality Assurance Specialist II is responsible for ensuring compliance with quality system's procedures and identifying and assessing regulatory and quality risks in activities and processes according to regulatory agency guidelines and company practices.

This unique role is accountable for routine Quality Systems / Assurance duties related to the production and disposition of products manufactured and tested on behalf of Neogene.

This role is based in Santa Monica, CA, and reports to the Sr Manager, QA.

Essential Functions and Responsibilities

• Provide quality systems / assurance support across technical operations functions (i.e. Manufacturing, Facilities & Engineering, Supply Chain, Quality Control, Analytical Development, Product Development / Manufacturing Sciences & Technology) within Neogene to assure compliance to the quality manual and maintain collaborative quality relationships.
• Investigate and manage deviations related to quality systems. Determine corrective / preventative actions (CAPA) and Verification of Effectiveness (VoE) and drive implementation.
• Work with appropriate stakeholders to effectively manage change controls in a phase appropriate manner for clinical stage products that supports quality risk management (i.

e. New Product Introduction, New Facility, & Manufacturing Process Change Controls).

• Provide ILT trainings as required for annual GMP / GDP, Quality Manual, Quality Risk Management, Deviation / CAPA, Change Control.
• Work with QA doc control to ensure accurate training documentation across TechOps.
• Work with QA doc control to ensure accurate issuance of batch record documentation (i.e. lot / media records and labels) to manufacturing.
• Reviews routine manufacturing batch documentation and quality control data for in-process and finished product to support disposition and lot closure.
• Perform review and approval of equipment alarm acknowledgements, equipment activation and PM / Calibration schedules in computerized asset and alarm management system(s).
• Review routine material release documentation for quality release of raw materials used for manufacturing and quality control testing.
• Perform other duties as assigned.

Required Skills / Abilities

• Knowledge of and ability to apply GMP in conformance to US standards.
• Proficient in cGMP regulations, quality systems and regulatory requirements.
• Experience writing, evaluating and closing investigations, CAPAs and change control records. Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Ability to effectively negotiate and build collaboration amongst individuals.
• Proficient in MS Word, Excel, Power Point and other applications.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Willingness to think outside of the box and adapt best practices for stage appropriate products.
• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

Education and Experience

5+ Years with High School Diploma , 2+ Years with BS / BA and 1+ Years with MS / MA.

We offer the opportunity to join a highly dynamic biotech company. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.

The anticipated salary range for candidates who will work in Santa Monica, CA is $70,000 to $82,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

At this time, Neogene is not sponsoring VISAs.

Neogene Therapeutics requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

DE&I Statement

Headline : We embrace our individual differences.

Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs.

Together, we strive to uphold a value system that promotes :

• Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view
• A collaborative culture that leverages the diverse perspectives of employees and supports courage
• Zero tolerance for discrimination

We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions.

We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist."