Quality Assurance Associate

4 weeks ago

Canada Valid8 Financial, Inc. Full time

Turnstone Biologics (“Turnstone”), a public clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1 trial in solid tumors for the lead TIL therapy candidate, TIDAL-01, and a Phase 1 trial in partnership with the Moffitt Cancer Center.

At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

POSITION OVERVIEW

We are seeking a highly effective, self-motivated, and versatile Quality Assurance professional with demonstrated knowledge of, and experience in, Quality Systems Management. As QA Associate you will support the team with a variety of systems including but not limited to: administration of our document management system and training program as well as support for change management, deviations/CAPAs, trending and Key Performance Indicators (KPIs). You will be responsible for ensuring that such systems and changes are supported in accordance with sound change management principles and Turnstone-defined procedures. This role is critical in maintaining a strong partnership with both our internal and external stakeholders in pursuit of advancing our pipeline. This role provides support remotely across all domestic time zones and reports into the Sr Manager for Quality Operations.

KEY RESPONSIBILITIES

  • Administration of electronic systems such as Veeva and LearnGxP including supporting system updates, managing and administering training, and supporting document control activities.
  • Support the trending of quality systems such as deviation, change control, and CAPA programs as well as creates, owns, and manages deviations, change control requests, and CAPA records pertaining to their functional area.
  • Supports the Quality Operations function in evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results, and other GMP documents as needed.
  • Provide administrative support for audit program and quality agreements.
  • Reads, understands, and follows SOPs, and complies with GMP.
  • Writes new standard operating procedures or revises existing documentation utilizing document management systems.
  • Assists in the implementation of new processes.
  • Assists in assembling quality metrics and KPIs.
  • Identifies, coordinates, and implements continuous improvements.
  • Prioritizes day-to-day support for their functional area and longer-term projects or investigations.
  • Creates/revises QA documents (gap assessments, risk assessments, reports) in document management system.
  • Facilitates and coordinates training of new and existing team members, prepares training materials as necessary.
  • Represents QA, as needed, during meetings relevant to their functional area, communicates and tracks all follow-up items through to completion
  • Additional duties as assigned.

QUALIFICATIONS

  • Bachelor’s in Biology, Engineering or science-related field preferred.
  • 2-4+ years industry experience, preferably in gene and cell therapy.
  • 2+ years of QA experience.
  • Experience in GMP environments including knowledge of change management principles and industry standard QMS applications.
  • Experience with Veeva, LearnGxP, DocuSign, SharePoint, SmartSheet are considered an asset.
  • Demonstrated ability to manage multiple tasks/projects with demanding timelines.
  • Strong interpersonal, teamwork, and organizational skills; effective oral and written communication skills.
  • Occasional travel to support cross-functional workshops or strategy/planning activities.

COMPENSATION

At Turnstone, we prioritize the well-being and success of our team. Join us and enjoy a competitive compensation package, including a base salary and performance-based bonuses. Our comprehensive benefits include:

  • Healthcare Coverage: Medical, dental, and vision insurance for you and your dependents.
  • Retirement Planning: 401(k) plan with employer contributions.
  • Time Off: Generous paid time off, including vacation, sick leave, and holidays.
  • Workplace Flexibility: Flexible schedules and remote work options.

Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

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