About the position
ARL Bio Pharma is the leading Pharmaceutical testing laboratory in the nation with an unparalleled reputation for quality science. The Quality Systems Analyst is responsible for ensuring that all Quality System requirements are met, in conjunction with various regulations and accrediting bodies. This is a safety sensitive position as defined by state and federal laws that will require working with hazardous materials and/or handling medicine. As a 'safety sensitive' classification, you will be subject to drug and alcohol testing, including random testing. Marijuana is one of the substances included in the drug panel screening. Possession of a medical marijuana license will not excuse you from the testing process, or the consequences of testing positive for marijuana. Work Schedule: This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 4:30 p.m. (assuming 30-minute lunch break)
Responsibilities
- Supports the Quality Department, EHS and Facilities in the implementation and review of Quality Systems policies and procedures.
- Completes routine workload in MasterControl including document control, review, editing, release, general troubleshooting, training files, employee or client onboarding/offboarding.
- Issues all Deviation Report, CAPA, Change Control & Risk Assessment numbers upon email request and maintains the number index for each in real-time.
- Reviews and completes Deviation Reports on a case-by-case basis.
- Assists with follow up communication of Deviation Reports, CAPA reports, Change Controls as needed.
- Runs weekly reports to update QA dept metrics for the Traction meeting.
- Assists with Client Audit preparation documentation, pre-audit walk-through review of laboratory areas and pulling documentation per request during the Audit.
- Assists with Internal Audit documentation, walk-through review of laboratory areas and pulling documentation for review during the Internal Audit.
- Supports any other QA department initiatives as needed.
- Ability to wear, maintain, and properly use appropriate safety equipment, including, but not limited to eye protection, gloves, and lab coat.
Requirements
- Associate's degree or equivalent in Chemistry or Biology.
- At least 1-2 years of experience in a laboratory setting.
- Bachelor's degree in Chemistry or Biology with 1 year experience in a regulated laboratory environment is preferred.
Benefits
- 100% Company-paid medical, dental and vision insurance
- Company-matched 401K retirement
- Generous paid time off and holidays
- Free lunch every day
- Opportunity to work in a great environment with amazing people
