JOB DESCRIPTION

The Quality Assurance Technician is responsible for reviewing and confirming compliance documentation related to raw materials, in-process samples, and finished product analyses. The role involves monitoring adherence to current Good Laboratory Practices (cGLP) by laboratory personnel and verifying that laboratory chemicals, reagents, and standards are properly labeled according to standard operating procedures (SOPs). The technician will also review laboratory audit trails, coordinate with analytical laboratory teams, manage documentation, identify system gaps, and support cross-functional initiatives.

ESSENTIAL SKILLS

• Strong command of English language communication skills, both verbal and written.
• Solid documentation and technical writing skills, with the ability to apply relevant scientific principles and practices.
• Ability to work under minimal supervision, both independently and in a team environment.
• Proficient computer skills and software applications such as Microsoft Office tools and Quality applications.
• Experience in analytical quality assurance, preferably in pharmaceutical manufacturing.
• Knowledge of analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, and analytical development.

ADDITIONAL SKILLS & QUALIFICATIONS

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field from an accredited institution required; Master’s degree preferred.
• 1-3 years of experience in analytical quality assurance.
• Experience with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
• Self-motivated with excellent organizational skills and the ability to focus on details.
• Experience with inhalation products (MDI) is a plus.
• Ability to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.

• Review and confirm compliance documentation related to raw materials, in-process samples, and finished product analyses.
• Monitor adherence to current Good Laboratory Practices (cGLP) by laboratory personnel during routine operations.
• Verify proper labeling of laboratory chemicals, reagents, and standards in accordance with SOPs.
• Review laboratory audit trails during data assessments to ensure alignment with SOPs.
• Coordinate with Analytical Laboratory Teams to compile and provide necessary documentation to cross-functional teams.
• Manage incoming documentation, including tracking, recording, storing, and archiving.
• Identify system gaps during routine monitoring and notify supervisors of areas requiring improvement.
• Understand laboratory equipment operation, qualification, and calibrations, including software audit trial reviews.
• Actively participate in the review of data related to laboratory investigations and incidents to ensure regulatory compliance.
• Support departmental and cross-functional initiatives and complete assignments as directed.