Cambrex
QA Specialist I
US-MA-Agawam
Job ID: 2024-3723
Type: Regular Full-Time
# of Openings: 1
Category: Quality Assurance
Cambrex
Overview
The QA Specialist I supports the Quality Management System (QMS) and the Document Management System (DMS) in a GMP regulated environment according to established operating procedures. The QMS and DMS functional areas include but are not limited to: Document Control, Training, Deviations, Out of Specification Investigations, Corrective and Preventive Actions (CAPA), Change Control, Complaints, Quality review of analytical and microbiological data and batch production records, Internal/external audits, supplier/subcontractor management, validation, and calibration & maintenance.
This role may participate 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. Ability to work within a dynamic and fast paced environment.
Responsibilities
• Responsible for performing an independent quality evaluation and release of support documentation, materials, products, equipment, and/or 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.
• Under manager supervision, able to comply with GMP, SOPs and basic regulatory guidance.
• Participates in department/client meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
• Ability to 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.
• Effectively resolves quality issues and concerns in a timely manner.
• Effectively coordinates and organizes tasks to help drive the activities of the department; while performing a variety of duties on schedule, with accuracy and competency.
• Ability to take direction from others and contribute in a team environment.
Qualifications
• Related BA/BS, required
• 0-2 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
PI240934421
