6224 - GMP Quality Specialist / Quality Specialist
About the position
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise
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
• 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
Apply tot his job
Apply To this Job
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise
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
• 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
Apply tot his job
Apply To this Job