Sr.QA Specialist I - Military veterans preferred

Cambrex


Sr.QA Specialist I

US-NC-Durham

Job ID: 2025-4245
Type: Regular Full-Time
# of Openings: 1
Category: Quality
Cambrex - Durham

Overview

The Senior QA Specialist I is an expert in their assigned area and has a strong understanding of current
FDA, EU and ICH requirements. This role may specialize in various aspects of technical data and
documentation evaluation and review, manufacturing operations, laboratory operations, investigations,
and a variety of routine and non-routine tasks. This role ensures that all QA activities are in compliance
with company SOPs, GMP/GLP standards and client requirements.

This role will coordinate with appropriate departments and/or cross-functional teams to ensure all
applicable documents are reviewed and released within the specified timeframes. Ability to work within
a dynamic and fast paced environment.

• Responsible for performing an independent quality evaluation and release of support
documentation, materials, products, equipment, and facilities.
• Ensure all testing/manufacturing was performed per approved SOPs/methods/protocols and comply
with specifications by critically evaluating the reported data and results for accuracy and compliance
with other regulatory guidelines.
• Works independently on problems of basic to moderately complex scope in which analysis of
situation or data requires a review of identifiable factors.
• Participates in department/client meetings, collaborates, and cooperates to achieve cross-functional
improvements and business goals.
• Foster a culture of quality and continuous improvement focused on value to the customer.
• Ability to host and/or participate in internal, client and/or regulatory audits. Works with the site
management in all areas to maintain a cGMP compliant facility in a constant state of inspection
readiness.
• Exercises judgment within defined procedures and practices to determine appropriate action (root
cause analysis tools, CAPA, etc.) for quality events.
• Good interpersonal skills and willing to ask questions about procedures and concepts.
• Participates in the development, implementation, and maintenance of procedures and policies to
comply with FDA, EU, and ICH requirements applicable to site’s needs.
• Able to be trained and train/ mentor others.
• Effectively resolves quality issues and concerns in a timely manner.
• Effectively coordinates and organizes tasks to help drive the activities of others; while performing a
variety of duties on schedule, with accuracy and competency.
• Creates strong and effective working relationships with Quality team, colleagues, and clients.

Related BA/BS, required.
• 4 -6 years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in
Quality Assurance.
• Experience in manufacturing operations, laboratory operations and/or QA, preferably in pharma or
biotech.

PI267451109