GMP Operational Quality Sr. Specialist

Job Description

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.

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 Analytical QA on cross-functional teams as an experienced Quality technical resource

Key Duties and Responsibilities(cont'd):

• 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

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/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

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/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

$55-65/hr