GMP Operation Quality, Specialist - QA Analytical (contract) 23883

Job Description

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

 

The ideal candidate will have experience with stability protocol author/ approval, QA experience - analytical data review and quality event management

 

KEY DUTIES AND RESPONSIBILITIES:

• Provides QA review of the GMP data in support of commercial product stability 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 oversight of Root Cause Analysis (RCA) and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. May approve investigations/CAPAs.
• Supports stability impacting change control activities such as assessment, implementation, and closure.
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reports.
• Supports external stability program activities for commercial products such as internal/external protocol review/approval, data review/approval and study initiation.
• Enforces Quality Agreements between CMOs/Suppliers and Vertex as applicable to stability study pulls, test initiation, data reporting and OOS/OOT management.
• Identifies and facilitates continuous improvement efforts.
• Identifies and communicates risks and assists with risk mitigation plans, where applicable.

 

 

KNOWLEDGE AND SKILLS:

• Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting including knowledge of global GMP requirements in regard to GMP manufacturing and testing.
• Knowledge of basic analytical techniques in a Quality/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)
• Experience working with Contract Manufacturing Organizations (CMOs)/Contract Testing Organization (CTOs).
• Experience supporting multiple projects/teams, ability to work in a fast-paced environment and meet quality, accuracy and timelines.
• Good communication skills (written and verbal) and the ability to communicate cross-functionally to a 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, RCA and CAPA implementation.
• Experience in assessing Change Controls
• Experience with electronic document management systems (e.g., LIMS, Veeva).

 

PREFFERED EDUCATION AND EXPERIENCE:

• Bachelor's degree in a scientific discipline (or equivalent degree) and 3-4 years of experience, or the equivalent combination of education and experience.
• Advance knowledge of GMP regulations and applicability.
• Operational QA experience in analytical or manufacturing setting, interpretation, and application of GMPs and applicable guidelines/guidance’s ex. ICH, USP, etc.
• Experience in Root Cause Analysis tools/methodology and technical writing.
• Facilitation/problem solving/organizational planning skills in a regulated environment.

Pay Range

$42-$48/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

 

By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information