Senior Quality Specialist

You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid‑phase peptide synthesis, solid‑state science, material characterization, and highly potent APIs.

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast‑paced growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more. Known for our customer‑focused scientific and manufacturing excellence, we provide a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

Do you want to help you matter in a career? Apply today!

The Senior Quality Assurance 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 cross-functional teams to ensure all applicable documents are reviewed and released within the specified time frames. Ability to work within a dynamic fast‑paced environment.

• Responsible for performing an independent quality evaluation and release of support documentation, materials, products, equipment, and facilities.
• Ensure all testing and manufacturing were 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 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.

Knowledge

• Strong attention to detail, as well as time and resource management.
• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to independently with minimal direction.
• Promote a safe environment for work.
• Communicate clearly and effectively both orally and in writing with internal and external clients.
• Working knowledge and understanding of LIMS and Empower.
• Skilled in Master Control, Trackwise and/or other QMS software applications.
• Underst…