Job Description

The GMP Operational Quality Specialist works with a high degree of independence to provide QA Analytical support for release and stability program for commercial products. The GMP Operational Quality Specialist executes routine tasks and activities in support of QA Analytical function.

KEY DUTIES AND RESPONSIBILITIES:

• Provides QA review of the GMP data in support of release of commercial product as required.
• Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.
• Represents QA Analytical on cross-functional teams as an experienced Quality technical resource as needed.
• Supports quality oversite of root-cause analysis and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. May approve investigations/CAPAs.
• Supports change control assessment, implementation, and closure as needed.
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reports.
• Supports analytical method validation and transfer activities for commercial and clinical products as needed.
• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed
• Identifies and facilitates continuous improvement efforts
• Supports generations and maintenance of Quality Metrics to support process improvement activities as necessary.
• Identify and communicate risks and assist with risk mitigation plans as necessary

KNOWLEDGE AND SKILLS:

• 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.
• Strong knowledge of basic analytical techniques in a QC/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)
• Experience working with CMO/CTO’s.
• Experience supporting multiple projects/teams, ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives
• Good communication skills (written and verbal) and the ability to communicate cross-functionally to a wide variety of audiences.
• 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.
• Experience in supporting Quality Event Investigations, Root Cause Analysis (RCA) and CAPA implementation.
• Experience in assessing Change Controls
• Experience with electronic document management systems (e.g., Trackwise, Veeva).

PREFFERED EDUCATION AND EXPERIENCE:

• Bachelor's degree in a scientific or allied health field (or equivalent degree) and 3-4 years of experience, or the equivalent combination of education and experience.
• Advance knowledge of GMP regulations and applicability to duties.
• Operational QA experience in analytical or manufacturing setting, interpretation, and application of GMPs and applicable guidelines/guidance’s ex. ICH, USP, etc.
• RCA tools/methodology/ technical writing
• Facilitation/ problem solving /organizational, planning, etc

Pay Range

$40-$50/hr

Requisition Disclaimer

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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If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors