Hybrid GMP Quality Specialist

at Verista, Inc.

• Job title: GMP Quality Specialist
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $60,000 - $86,276 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Boston, United States

About the role

• Quality Specialist providing GMP oversight and compliance support in life sciences industry. Involves managing quality issues and ensuring regulatory compliance for manufacturing operations.

Responsibilities

• 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