GMP Operational Quality Sr. Specialist (Contract) 657

Atrium Works • Boston, MA

2d

About The Position

The GMP QA Analytical Sr. Quality Specialist is recognized as a subject matter expert in the principles and application of quality assurance and compliance in support of the QA Analytical function. This role supports and executes a wide range of activities related to clinical and commercial programs.

Requirements

• Working knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing and testing.
• Working knowledge of basic analytical techniques in a QC setting (examples: HPLC, Dissolution, GC, KF, NMR, XRPD, PSD, Water Activity, Compendial Methods).
• Experience in assessing Change Controls.
• Experience in leading and managing Event Investigations, Root Cause Analysis (RCA), and monitor CAPA implementation.
• Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva).
• Experience supporting multiple projects/teams, ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
• Experience working with CMO/CTOs.
• Demonstrated ability to work independently to provide QA advice for large, multifaceted projects.
• Demonstrated ability to evaluate quality matters and make decisions leveraging technical experience and judgment.
• Strong communication skills (written and verbal) and the ability to communicate cross-functionally to a wide variety of audiences.
• Facilitation/ problem solving /organizational, planning.
• Advance knowledge of GMP regulations and applicability to duties.
• Operational QA experience in analytical and/or manufacturing setting, interpretation, and application of cGMPs and applicable guidelines/guidance’s (example: ICH, USP).
• RCA tools/methodology/ technical writing.
• Bachelor's degree in a scientific or allied health field (or equivalent degree).
• Typically requires 2-4 years of experience, or the equivalent combination of education and experience.

Responsibilities

• Provides QA review of GMP data in support of stability and release of clinical products.
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports.
• Supports analytical method validation, verification, and transfer activities for clinical products.
• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed.
• Supports change control assessment, implementation, and closure; assesses and approves change controls.
• Supports quality oversight of root-cause analysis and product impact assessment for deviation and OOS/OOT investigations. Ensures that appropriate CAPA actions are identified.
• Approves investigations/CAPAs.
• Supports generation and maintenance of Quality Metrics to support process improvement activities, as necessary.
• Represents Analytical QA on cross-functional teams as an experienced Quality technical resource.
• Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support of the Analytical QA function.
• Identifies and communicates risks and assists with risk mitigation plans as necessary.
• Supports internal audit or external audit programs as necessary.
• Assists in preparation of audit responses as necessary.
• Supports continuous improvement projects; may facilitate improvement efforts.

Benefits

• compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
• eligible for overtime pay, in accordance with federal and state requirements

What This Job Offers

• Job Type: Full-time
• Career Level: Senior