Verista, Inc.

GMP Quality Specialist

Verista, Inc.

full-time

Posted on:

Location Type: Hybrid

Location: Boston • Massachusetts • United States

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Salary

💰 $60,000 - $86,276 per year

About the role

  • Provide GMP quality oversight and technical support to internal manufacturing operations and contract manufacturers (CMOs), ensuring compliance with Quality Agreements and regulatory requirements
  • Support change control activities, including impact assessments, implementation, review, approval, and closure in accordance with established procedures
  • Manage and approve deviations, OOS/OOT investigations, and root cause analyses, ensuring appropriate product impact assessments and effective CAPA implementation
  • Conduct comprehensive GMP document review, including Master and Executed Batch Records, validation protocols, and summary reports to support batch disposition and on-time release
  • Monitor and maintain Quality Metrics, proactively identifying risks and driving mitigation strategies to ensure compliance and operational performance
  • Collaborate cross-functionally to support continuous improvement initiatives, strengthen quality systems, and enhance overall GMP compliance

Requirements

  • Bachelor’s degree in Life Sciences, Information Systems, Quality, Engineering, or a related discipline
  • 3+ years of experience working in GxP-regulated environments with strong knowledge of applicable regulations (e.g., 21 CFR Part 11, Annex 11, data integrity principles)
  • Strong working knowledge of cGMP requirements governing drug substance and drug product manufacturing (oral solid dosage forms preferred)
  • Proven experience leading deviations, event investigations, Root Cause Analysis (RCA), and CAPA in a regulated pharmaceutical environment
  • Demonstrated ability to support multiple cross-functional projects in a fast-paced setting, ensuring quality, accuracy, and on-time deliverables
  • Effective communicator with the ability to evaluate quality issues, apply sound technical judgment, and collaborate across departments to resolve compliance matters
  • Ability to be on-site, part-time in South Boston, MA (Seaport area). 3 days per week on-site at a minimum.
Benefits
  • 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 (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMP quality oversightchange control activitiesdeviations managementOOS investigationsOOT investigationsRoot Cause Analysis (RCA)CAPA implementationGMP document reviewQuality Metrics monitoringdata integrity principles
Soft Skills
effective communicationtechnical judgmentcross-functional collaborationproject managementrisk identificationproblem-solvingattention to detailadaptabilityleadershipcontinuous improvement