6224 - GMP Quality Specialist / Quality Specialist

Verista•Boston, MA

20h•Hybrid

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

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.

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