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Senior Quality Assurance Associate
4 months ago
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 Senior Quality Assurance Associate will support the Quality Assurance department by performing QA activities related to supplier quality management associated with clinical manufacturing. The Senior Quality Assurance Associate executes and resolves material quality issues through Supplier Corrective Action Report (SCAR) Program with vendor and supports supplier qualification process, including supplier audits. The Senior Quality Assurance Associate monitors and drives supplier performance, maintains compliance for site activities associated with local/ global Supplier Management, and maintains compliance with regulatory/company quality standards. This role is based in Santa Monica, CA, and reports to the Associate Director of Quality.
Essential Functions and Responsibilities
- Work closely with Supply Chain, Operational site QA, Quality Control, Process Development, Analytical Development, and external Suppliers.
- Review and approval of Supplier Deviations, CAPAs, SCARs.
- Assess Global Supplier Notifications and Supplier related complaints.
- Perform and coordinate supplier audits.
- Manage the approved supplier list, supplier risk management programs and supplier performance from quality perspective.
- Review of documentation including but not limited to, risk and technical assessments, vendor related documentation, material qualification packages, and audit reports associated with clinical processing and ensuring adherence to regulatory agency requirements, standards, policies, and values in timely manner.
- Responsible for Quality agreement generation and periodic reviews.
- Contribute to the Annual Product Reviews from a Supplier management perspective.
- Manage the supplier and material selection process.
- Support onboarding of new suppliers and materials.
- Drive quality continuous improvement plan initiatives including activities related to quality risk management, analysis, strategy development and project management.
- Support quality oversight of raw materials, components, and excipients.
- Manage change controls related to Suppliers and materials.
- Identify potential quality or compliance concerns and escalate to management.
- Support additional Quality management needs as directed by management.
- Experience in Supplier Quality Management or Quality Assurance is highly preferred.
- Knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.
- Proficient in cGMP regulations, quality systems and regulatory requirements.
- Experience writing, evaluating, and closing investigations, CAPAs and change control records.
- Experience with supporting and managing internal and external audits.
- 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.
- Self-motivated, positive and ability to work under pressure.
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- 5+ Years with High School Diploma , 2+ Years with BS/BA and 1+ Years with MS/MA.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to:
- Sit and talk or hear
- The employee frequently is required to use hands to finger, handle, or feel
- The employee is occasionally required to stand, walk, and reach with hands and arms
- The employee must occasionally lift and/or move up to 10 pounds.
- Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
- The noise level in the work environment is usually moderate.
- May be required to travel by plane or car 10% of the time.
Note: At this time, Neogene is not sponsoring VISAs.
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."
