Position Summary...
Required Education and Experience
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)
- 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
Job Duties...
- Supports the Quality Department, EHS and Facilities in the implementation and review of Quality Systems policies and procedures.
- Responsibility for completing routine workload in MasterControl including document control, review, editing, release, general troubleshooting, training files, employee or client onboarding/offboarding, etc.
- Responsibility for issuing all Deviation Report, CAPA, Change Control & Risk Assessment numbers upon email request and maintaining the number index for each in real-time.
- Responsibility for reviewing and completing Deviation Reports on case-by-case basis.
- Assists with follow up communication of Deviation Reports, CAPA reports, Change Controls as needed.
- Responsibility of running 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.
- Support 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.
Position Requirements...
Associate’s degree or equivalent in Chemistry or Biology (or)
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
Work Environment...
This job operates in a professional office and laboratory environment. Attendance at the office is required.
This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Physical Demands...
Speaking, listening, sitting, writing, visual acuity, lifting: The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this Job, the employee is regularly required to sit; use hands to handle or feel and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee will occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Position Type/Expected Hours of Work
AAP/EEO Statement
ARL Bio Pharma, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics or any other characteristic protected by state, federal, or local law. ARL Bio Pharma, Inc. expressly prohibits any form of workplace harassment based on race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics or any other characteristic protected by state, federal, or local law. Improper interference with the ability of ARL Bio Pharma, Inc. employees to perform their job duties may result in discipline up to and including discharge. Further, the company takes affirmative action to ensure that applicants and employees are treated without regard to any of these characteristics.
