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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 to support Drug Product facility, including start-up of assembly, packaging, and label operations.
  • Responsible for batch disposition activities, including review of batch data, deviations, in-process data, EM data, QC release testing, and other quality systems.
  • Review and approval of COAs and product release.
  • Provide production floor support and guidance for GMP product quality and compliance, including resolution of product quality investigations and quality issues of a significant nature.
  • Review and approval of manufacturing documents.
  • Develop and deliver technical training programs.
  • Support drafting and revising Quality Agreements between CMOs/Suppliers and site, as needed.
  • Provide QA support of change controls, GMP investigations, and CAPAs, including OOS and OOT investigations and ensuring appropriate CAP actions are identified.
  • Provide experienced technical advice for fill finish related program decisions.
  • Provide project support involving technical transfers, engineering projects, and similar activities.
  • Participate in compliance walkthroughs and help drive the closure of any observations.
  • Responsible for identifying risks and communicating gaps for GMP process/systems.
  • Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems, etc.
  • Participate in continuous improvements of department processes.
  • Participate in inspection readiness and support activities.
  • Participate in process improvement initiatives, as necessary.
  • Act as a trusted advisor to the site, providing compliance guidance through collaborative review and working with business owners to gain a better understanding of their needs and facilitate resolution of quality issues in a timely manner.
  • Experience with product complaints investigations and recalls.

**Requirements**

  • Demonstrated success by independently 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, with proficient knowledge of cell and gene therapy cGMPs and associated CMC regulatory considerations, aseptic processing, and network-based applications such as Oracle, TrackWise.
  • Experience successfully leading event investigations, Root Cause Analysis, and CAPA.
  • 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, or relevant comparable background.

**Benefits**

Verista offers a competitive compensation package, including:

  • 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.