Quality Control Specialist

About CAI

CAI is a fully employee-owned company founded in 1996 that has expanded to employ nearly 700 personnel globally. The company specializes in commissioning, qualification, validation, start-up, project management, and consulting services geared towards operational readiness for FDA-regulated and other critical industries.

CAI prioritizes client-focused service, ensuring completion of tasks to the highest standard. The organization upholds foundational principles including integrity, mutual service among employees, societal contribution, and future-oriented work. As employee-owners, team success is collective, fostering respect, teamwork, and a positive mindset which has driven substantial growth.

Employees gain access to cutting-edge technologies in advanced medicine sectors and collaborate with subject matter experts to bring life-saving treatments to market, such as COVID-19 vaccines and therapies. The company invests in employee advancement through hands-on certifications and professional training within a collaborative working environment.

Role Overview

• Assist with establishing and operationalizing a new Quality Control laboratory.
• Lead or assist in transferring, validating, and qualifying analytical methods for internal laboratory application.
• Develop and enforce rigorous procedures for method documentation and compliance adherence.
• Conduct quality testing on incoming raw materials to verify they meet required specifications.
• Perform in-process quality evaluations to support manufacturing and scale-up processes.
• Carry out and record final product testing to facilitate batch release.
• Investigate abnormal or out-of-specification results collaboratively with Quality Assurance teams.
• Maintain strict adherence to GMP documentation and accurate record-keeping.
• Support the formulation and refinement of Standard Operating Procedures (SOPs), forms, and testing records.
• Participate in audits, internal inspections, and initiatives focused on continuous improvement.

Candidate Requirements

• Demonstrated practical experience in a Quality Control capacity within pharmaceutical, biotechnology, or related laboratory settings.
• Profound understanding of laboratory instruments and analytical methods for both raw materials and finished product evaluation.
• Proven experience with method transfer processes and laboratory setup is highly valued.
• Sound knowledge of GMP/GLP standards and regulatory requirements affecting QC functions.
• Exceptional attention to detail, strong organizational capabilities, and effective problem-solving skills.
• Ability to work independently and adapt efficiently in a dynamic, start-up environment.

Additional Information

CAI may implement artificial intelligence tools during the recruitment process for application screening, resume analysis, and verification of candidate responses. Such tools assist recruiting personnel but do not replace human decision-making, which remains final. For further details on data processing policies related to hiring, interested individuals may inquire directly.