Senior Quality Assurance Associate

5 days ago

Santa Monica, United States Neogene Therapeutics Full time

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

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.

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.

Education and Experience

  • 5+ years with High School; 2+ years with BS/BA; 1+ years with MS/MA or Eng Degree
  • 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.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $70,000 to $82,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Benefits

  • Short-term incentive bonus opportunity
  • Equity-based long-term incentive program
  • 401(k) plan
  • Paid vacation and holidays; paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage.

DE&I Statement

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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