QA Laboratory Specialist (Instrumentation)

The QA Laboratory Specialist - Instrumentation is responsible for ensuring the proper qualification, calibration, and maintenance of QC laboratory instruments. This role involves generating and reviewing qualification documentation, developing SOPs, and supporting instrument lifecycle activities in a regulated environment. The ideal candidate will have experience with solid dosage form testing and the ability to work under pressure, including extended shifts and weekends as needed. Key Responsibilities: Perform and/or review calibration and preventive maintenance (PM) activities for QC laboratory instruments.

Generate and review qualification documentation such as user requirements (UR), functional specifications, protocols, reports, method validation, and data integrity assessments. Develop, implement, and maintain standard operating procedures (SOPs) for QC instrumentation. Ensure compliance with GMP and regulatory requirements for equipment qualification and maintenance. Collaborate with QC, QA, Validation, and IT teams to support instrument lifecycle management. Demonstrate knowledge of analytical testing for solid dosage products, including tablets and capsules. Support the laboratory by working extended shifts and/or weekends when required. Operate effectively under pressure to meet critical deadlines and project timelines. RequirementsQualifications:

Bachelor's degree in Chemistry, Engineering, or related scientific field required. Minimum 2-4 years of experience in QC instrumentation, calibration, or equipment qualification in a regulated (FDA/GMP) environment. Strong knowledge of qualification protocols, method validation, and data integrity standards. Experience with analytical instruments such as HPLC, GC, UV, dissolution testers, etc. Understanding of solid oral dosage manufacturing and testing processes. Excellent technical writing and documentation skills. Ability to prioritize and manage multiple tasks in a fast-paced environment.