Job Title: Quality Assurance Technician

Job Description

As a Quality Assurance Technician, you will be responsible for reviewing compliance documentation related to raw materials, in-process samples, and finished product analyses. You will monitor adherence to current Good Laboratory Practices (cGLP) by laboratory personnel during routine operations to ensure procedural compliance. Additionally, you will verify that laboratory chemicals, reagents, and standards are properly labeled in accordance with standard operating procedures (SOPs).

Responsibilities

• 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 in an organized manner.
• Identify system gaps during routine monitoring and notify supervisors of areas requiring improvement.
• Understand laboratory equipment operation, qualification, and calibrations, including their software audit trail 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 by the manager or supervisor.

Essential Skills

• Strong documentation and technical writing skills, with the ability to apply relevant scientific principles and practices.
• Ability to work under minimal supervision, independently, and in a team environment.
• Proficiency in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.
• Experience in analytical quality assurance with a focus on inhalation products (MDI) is a plus.
• Effective interpersonal relationship skills and the ability to work in a team environment.

Additional Skills & Qualifications

• Possess a minimum bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field from an accredited institution. A master's degree is preferred.
• A minimum of 1-3 years of experience in analytical quality assurance.
• Proficiently speak English as a first or second language and ability to read, write, and communicate effectively.
• Self-starter with the initiative to seek additional training or direction as needed.
• Knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good documentation Practices (GDP).
• Willingness to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.

Work Environment

Work primarily during the first shift from 8:30 AM to 5:00 PM, Monday to Friday. You will be part of a supportive team of 15-20 people, collaborating with the manufacturing team. Reporting directly to the QA Manager, you will be required to stand or walk unassisted for 75% or more of an 8-hour period and may need to lift up to 10 kg unassisted. Appropriate personal protective equipment must be worn when required. You will spend considerable time sitting at a desk and working at a computer or other screens.