GMP Operational QA- Analytical Senior Specialist (Contract)

Atrium Works•Boston, MA

12h•$55 - $65

About The Position

The GMP QA Analytical Sr. Quality Specialist recognized as a subject matter expert in the principles and application of quality assurance and compliance in support of QA Analytical function. The Sr. Quality Specialist supports and executes wide range of activities related in support of clinical and commercial programs. The candidate must have expertise in analytical lab testing, change controls and quality event managment.

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/CTO’s
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 judgement
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 the 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 oversite of root-cause analysis and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified.
Approves investigations/CAPAs
Supports generations 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 Analytical QA function
Identify and communicate risks and assist with risk mitigation plans as necessary
Supports internal audit or external audit programs as necessary
Assists in preparation of audit responses as necessary
Support continuous improvement projects; may facilitate improvement efforts