GMP Operational QA- Analytical, Senior Specialist (Contract) 25629

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 programs.

This is a hybrid role mostly remote but ability to travel locally to Boston as needed.

Key Duties and 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 QA Analytical 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 QA Analytical 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

Knowledge and Skills:

• 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 judgement
• Strong communication skills (written and verbal) and the ability to communicate cross-functionally to a wide variety of audiences

Education and Experience:

• 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/guidances (example: ICH USP).
• RCA tools/methodology/ technical writing
• Bachelors 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

$55-$65/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by law. In addition this role will be eligible for overtime pay in accordance with federal and state requirements

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No C2C or Third-Party Vendors