Senior Quality Assurance Specialist I

About the role

The Senior Quality Assurance Specialist I at Cambrex is responsible for ensuring all QA activities comply with company SOPs, GMP/GLP standards, and client requirements. This role involves evaluating and releasing support documentation, materials, products, equipment, and facilities. It also entails collaborating with cross-functional teams to ensure documents are reviewed and released within specified timeframes.

Responsibilities

• Perform independent quality evaluations and releases of support documentation, materials, products, equipment, and facilities.
• Evaluate and verify that all testing/manufacturing is done according to approved SOPs/methods/protocols and complies with specifications.
• Participate in department/client meetings and collaborate to achieve cross-functional improvements and business goals.
• Foster a culture of quality and continuous improvement focused on customer value.
• Host and/or participate in internal, client, and/or regulatory audits.
• Maintain a cGMP compliant facility in a state of constant inspection readiness.
• Exercise judgment to determine appropriate actions for quality events using root cause analysis tools, CAPA, etc.
• Show good interpersonal skills and willingness to ask questions about procedures and concepts.
• Develop, implement, and maintain procedures and policies to comply with FDA, EU, and ICH requirements.
• Able to be trained and train/mentor others.
• Resolve quality issues and concerns promptly.
• Organize and coordinate tasks to support the activities of others.
• Create strong working relationships with the Quality team, colleagues, and clients.

Qualifications/Skills

• Strong attention to detail and time/resource management.
• Strong personnel and professional integrity and trustworthiness with excellent work ethics.
• Effective communication skills, both verbal and written.
• Working knowledge and understanding of LIMS and Empower.
• Skilled in MasterControl, Trackwise, and/or other QMS software applications.
• Understanding of validation, production equipment, utilities, and/or drug development/manufacturing operations.
• Demonstrated theoretical understanding and effective evaluation of laboratory practices such as raw material, drug substance, drug product, and medical device testing, compendia methods (e.g., USP/NF, EP, JP), and method validation/qualification/transfer, as required.
• Capable of demonstrating continued upward growth and technical contributions.
• Strong analytical and problem-solving skills with proven ability to think strategically.
• Strong understanding of current FDA, EU, and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
• Effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
• Excellent diplomatic, analytical, and communication skills - both verbal and written.
• Recognized as a technical resource in their assigned area.
• Strong computer skills, including proficiency in Microsoft Suite.

Education, Experience & Licensing Requirements

• 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.
• Supervision received: general supervision, exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results, acts independently to determine methods and procedures on new assignments, may seek management direction for problems of diverse and/or complex scope.