Quality Systems Analyst

Base Pay Range

$20.00/hr - $22.00/hr

Join a company where you can make a difference from day one and help make the world a better and safer place. ARL Bio Pharma provides analytical and microbiological testing for the pharmaceutical industry. Our laboratory works with pharmaceutical companies, compounding and hospital pharmacies, drug manufacturers, and raw material suppliers bringing excellence to pharmaceutical sciences and making pharmaceuticals safer. This position is a fantastic stepping‑stone for those looking to expand their career in the interesting world of the pharmaceutical industry.

The Quality Systems Analyst assists in the control, approval, and compliance verification of 100+ documents across several unique laboratories within the company. The role must understand federal and state regulations such as Title 21 of the Code of Federal Regulations Part 11 (21 CFR Part 11), Environmental Health & Safety (EHS), Food & Drug Administration (FDA) and Occupational Safety & Health Administration (OSHA) to ensure appropriate documentation is coded and uploaded into the company’s systems.

The Quality System Analyst will, at times, inspect and audit the Master Control, electronic Quality Management System (eQMS), for errors or improperly coded items. This position will create, update, archive documents and complete deviation reports. The QS Analyst interacts with clients and vendors to appropriately create and remove guest accounts for review of materials related to audits.

Additionally, the analyst partners with senior department personnel to develop, implement, and review current and new policies and procedures to create consistent and continuous improvement and compliance with all regulations, including various USP documents.

• Pay rate includes a 10% differential for evening shift
• Paid training
• Work in a comfortable office setting with a casual dress code
• Own workspace – largely independent work
• Free medical and dental insurance
• 401(k) retirement with company match
• Excellent work/life balance

Members of the Quality Control Team are expected to complete 8 hours a day with the majority during normal company business hours, allowing for some flexibility. Normal business hours are Monday‑Friday, 8:00 a.m. – 6:00 p.m. Some flexibility is required for occasional extensions before or after normal hours, and weekends will be required as part of an on‑call rotation.

Restrictions:
Because of the vital nature of this work, medical marijuana cards are not allowed and random drug testing is conducted on all employees.

• Support the Quality Department in implementing and reviewing policies and procedures, suggesting new processes to ensure continuous improvement and compliance with regulations.
• Inspect and audit the Master Control and other internal company systems for errors, missing files, or improperly coded documents.
• Assist with deviation reports and investigations to maintain compliance with 21 CFR Part 11.
• Assist leadership with document control of approving, updating, correcting, archiving, and implementing controlled documents.
• Assign and develop codes for training of analysts across multiple laboratories.
• Create, update, and archive training documents for 400+ personnel to maintain records of training and knowledge verification.
• Manage guest accounts for clients and vendors as appropriate.
• Communicate with clients, vendors, and other outside agencies as needed.
• Adhere to and maintain PPE and laboratory safety equipment, identifying hazards; may use a full‑face respirator in addition to standard PPE.
• Complete all safety training, including OSHA, SOPs, and company compliance.
• Maintain current knowledge of trends, techniques, and technology relevant to the field.

High School Diploma or equivalent with 1 year experience.

Or an Associate degree in Quality Management, Science or equivalent with 2 years of laboratory experience and/or 1 year in facilities or quality investigations.

• Experience with Master Control or similar electronic quality management systems.
• Knowledge of 21 CFR Part 11, USP, ISO 17025:2017, and…