QA Analyst

Overview

Primary objective:
The Quality Assurance Analyst 1 will coordinate the quality assurance and quality control functions of the laboratory, working with the QA Director to implement and update quality programs to maintain compliance with the corporate quality program and lab accreditation.

• Review raw data and associated analytical reports for accuracy and compliance.
• Perform final report review and QA release.
• Review validations and method transfers for Chemistry and Microbiology.
• Conduct daily verification of Chemistry and Microbiology balances and coordinate verification activities when needed.
• Generate, review, release, file, and archive media batch records.
• Oversee DEA sample receipt, Controlled Substance program management, and disposal process.
• Review instrument calibration and validation documents.
• Monitor temperature‑controlled units and investigate related issues.
• Ensure vendor qualifications are current through oversight of the Vendor Qualification Program.
• Review and approve deviations, OOS investigations, CAPA proposals, and other requests.
• Ensure adherence to department procedures and revise relevant procedures.
• Perform internal audits, follow up with corrective actions, and assist with audit report distribution.
• Assist with Blue Sheet review and QA release as requested.
• Support trending documentation for Management Review.
• Maintain a clean and orderly workspace and practice proper cGDP.
• Exercise laboratory safety practices and use appropriate PPE.

• Bachelor’s degree in Chemistry.
• 0‑2 years of relevant laboratory or pharmaceutical industry experience.
• Familiarity with electronic Document Control systems (e.g., Compliant Pro) preferred.
• Knowledge of documentation functions within a cGMP or ISO regulated environment.

• Proficient verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Proficient computer skills, specifically Microsoft Office and Adobe Acrobat.
• Flexibility and professionalism when dealing with changing priorities.
• Awareness of regulatory compliance requirements.

Follow all company operating procedures and standards, participate in the ALS safety program, support HSE initiatives, enforce health and safety policies, and report incidents and injuries as required.

Work at a computer up to 8 hours per day, sit, stand, bend, lift up to 25 lb, and remain physically mobile up to 50% of the time while performing duties.

ALS is an equal‑opportunity employer; qualified candidates will be considered without regard to race, color, religion, national origin, military status, gender, age, disability, sexual orientation, gender identity, pregnancy, genetic information, or other protected characteristics.