Senior Associate, QA Compliance

Quality Assurance Compliance Specialist

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs).

We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.

This position is responsible for Quality Assurance Compliance activities supporting deviations, CAPAs, change control, and product releases.

Duties/Responsibilities:

• Support the deviation and CAPA/SCAR Systems by investigating, reviewing, assessing, tracking, follow-up, and completing all quality events.
• Support the Change Control program by reviewing, assessing, tracking, follow-up, and completing all change control documentation.
• Maintain databases and metrics.
• Identify and communicate compliance gaps; propose phase appropriate solutions.
• Track the status of Deviations, CAPAs, and Change Controls.
• Perform internal and/or external audits, as needed.
• Support product releases by reviewing batch records.
• Support risk assessment activities.
• Support audits by regulatory or state agencies and partners.
• Follow applicable regulations, including FDA, ISO, ICH, and company policies and procedures.
• Support other QA department needs as identified by management.

Requirements:

• Bachelor's degree or a combination of relevant education and applicable job experience
• 5+ years' experience in an FDA regulated industry and CGMP regulations.
• Late-phase to commercial phase experience a plus.
• Cell Therapy experience a plus.

In addition to a great culture, we offer:

• A beautiful facility
• An entrepreneurial, highly collaborative, and innovative environment
• Comprehensive benefits, including:
• Medical, Dental, and Vision
• Group Life Insurance
• Long Term Disability (LTD)
• 401(k) Retirement Plan
• Employee Assistance Program (EAP)
• Flexible Spending Account (FSA)
• Paid Time Off (PTO)
• Company paid holidays, including the year-end holiday week
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.

If all this speaks to you, come join us on our journey!