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Quality Assurance Specialist

2 months ago

Boston, Massachusetts, United States Verista Full time
Job Description

**About Verista**

Verista is a leading provider of innovative solutions and services to the life science industry. Our team of experts works closely with the world's most recognizable brands to empower growth and innovation within the scientific community.

**Job Summary**

We are seeking a highly skilled Quality Assurance Specialist to join our GMP Operational Quality group. The successful candidate will provide quality oversight and support to site Cell and Gene Therapy operations, ensuring compliance with regulatory requirements and industry standards.

**Key Responsibilities**

  • Provide quality oversight and support to site Cell and Gene Therapy operations, including manufacturing, analytical laboratory, materials management, and facility/engineering groups.
  • Lead QA efforts to establish new programs and support the start-up of assembly, packaging, and label operations.
  • Review batch data, including batch records, deviations, in-process data, EM data, QC release testing, and other quality systems to determine product disposition.
  • Approve COAs and product release, ensuring compliance with regulatory requirements.
  • Provide production floor support and guidance on GMP product quality and compliance, including resolution of product quality investigations and quality issues.
  • Review and approve manufacturing documents, including technical training programs.
  • Support drafting and revising Quality Agreements between CMOs/Suppliers and site.
  • Provide QA support for change controls, GMP investigations, and CAPAs, including OOS and OOT investigations.
  • Provide experienced technical advice for fill finish related program decisions.
  • Support project activities involving technical transfers, engineering projects, and similar activities.
  • Participate in compliance walkthroughs and drive the closure of any observations.
  • Identify risks and communicate gaps for GMP process/systems and quality processes optimization.
  • Participate in continuous improvements of department processes.
  • Participate in inspection readiness and support activities.
  • Act as a trusted advisor to the site, providing compliance guidance and facilitating resolution of quality issues.

**Requirements**

  • Demonstrated success in leading cross-functional teams.
  • Experience providing QA support and oversight of GMP manufacturing operations, including batch release.
  • Experience with ATMP drug product development and manufacturing, including knowledge of cGMPs and associated CMC regulatory considerations.
  • Experience successfully leading event investigations, Root Cause Analysis, and CAPA.
  • Experience with network-based applications, such as Oracle and TrackWise.
  • Master's degree with 2-3 years of relevant work experience or Bachelor's degree in a scientific or allied health field with minimum 3-5 years of relevant work experience.

**What We Offer**

  • High growth potential and fast-paced organization with a people-focused culture.
  • Competitive pay plus performance-based incentive programs.
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances.
  • FSA, DCARE, Commuter Benefits.
  • Supplemental Life, Hospital, Critical Illness, and Legal Insurance.
  • Health Savings Account.
  • 401(k) Retirement Plan (Employer Matching benefit).
  • Paid Time Off (Rollover Option) and Holidays.
  • As Needed Sick Time.
  • Tuition Reimbursement.
  • Team Social Activities.
  • Employee Recognition.
  • Employee Referral Program.
  • Paid Parental Leave and Bereavement.