GMP Operational Quality Sr. Specialist (Contract) 657

Vertex Pharmaceuticals; Boston (MA); On-site; USD 76,000 - 90,000; Full time

Job summary

Vertex Pharmaceuticals in Boston seeks a GMP QA Analytical Sr. Quality Specialist to serve as a subject matter expert in QA and compliance for the Analytical function. The role supports clinical and commercial programs and collaborates across teams to ensure rapid, accurate quality decisions.

This senior specialist conducts GMP reviews, helps with change control, investigations, CAPA, and quality metrics, and represents Analytical QA on cross-functional projects in a fast-paced environment.

Qualifications

• Bachelor's degree in a scientific field or equivalent
• 2–4 years of QA analytical or manufacturing experience
• Working knowledge of cGMPs, ICH, USP guidelines

Responsibilities

• Provides QA review of GMP data for stability and release of clinical products
• Conducts GMP document review (procedures, work instructions, specs, methods)
• Supports analytical method validation/verification/transfer for clinical products
• Drafts and enforces Quality Agreements with CMOs/Suppliers
• Supports change control assessment, implementation and closure; approves investigations/CAPAs
• Supports quality oversight of deviation, OOS/OOT investigations and risk mitigation
• Represents Analytical QA on cross-functional teams
• Collaborates with internal/external partners to resolve quality issues
• Assists in preparation of audit responses and participates in audit programs

Skills

Quality assurance

GMP knowledge

Analytical techniques

Change controls

Investigations RCA CAPA

Cross-functional collaboration

Communication skills

Document management systems

Education

Bachelor's degree in science

Tools

QDoccs

Trackwise

Veeva

Job description

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

Pay Range

$55-65/hr