Quality Systems Analyst

ARL Bio Pharma•Oklahoma City, OK

51d•Onsite

About The Position

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 with general oversight assists in the control, approval, and compliance verification of 100s of documents across several unique laboratories within the company. This position 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 MasterControl, electronic Quality Management System (eQMS), for errors/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 in the company's own systems for review of materials related to appropriate audits. Additionally, will partner 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 (United States Pharmacopeia) documents. Some highlights... Pay rate includes a 10% differential for evening shift Paid Training Work in a comfortable office setting with casual dress code Have your own workspace where you can work largely independently Free Medical and Dental insurance 401K Retirement with Company Match Excellent Work/Life Balance This is a full-time role with a great benefits package. Work Schedule: 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 of shifts. Normal Company business hours of operation are Monday through Friday, 8:00 a.m. to 6:00 p.m. Some Flexibility is required as occasional extensions before or after normal company business hours, and weekends will be required as part of an on-call rotation. Restrictions: Because of vital nature of this work, we do not allow medical marijuana cards and we do random drug testing on all of our employees.

Requirements

High School Diploma - or equivalent Diploma with an additional 1-year experience.
Or
Associate degree in Quality Management, or Science Field - or equivalent diploma with 2 years of experience in a Laboratory Environment and/or 1 year of experience in Facilities or Quality investigations.

Responsibilities

Supports the Quality Department in implementing and reviewing policies and procedures, suggesting new processes to ensure continuous improvement and compliance with federal, state, and industry regulations.
Inspect and audit the MasterControl and other internal Company systems for errors, missing files, or improperly coded documents.
Assist with Deviation reports & Investigation to maintain company compliance with regulations such as Title 21 of the Code of Federal Regulations Part 11 (21 CFR Part 11).
Assist Department Leadership in document control of approving, updating, correcting, archiving, and implementation of controlled documents for maintaining compliance with federal, state, local, and company regulations.
Assign & Develop codes for training of analysts across multiple unique laboratories, including those for microbiology, chemistry, analytical chemistry, research and development, and quality control review.
Create, update, and archive training documents for 400 + laboratory personnel to maintain a true record of training and knowledge verification for SOPs, Trainings, Compliance, ISO 17025:2017 standard, various industry USPs, ext.
Assist in adding, removing, and adjusting guest accounts in the company's own systems for clients and vendors as appropriate.
Direct communication with clients, vendors, and other outside agencies as appropriate in the execution of duties.
Adhere to, use, and maintain Personal Protective Equipment (PPE) and Laboratory Safety Equipment, and identify hazards that may arise. Including the ability to wear a full-face respirator in addition to standard Personal Protection Equipment.
Complete all safety training, including but not limited to OSHA, Departmental SOPs, and Company Compliance
Maintains current knowledge of trends and developments in techniques and technology relevant to the field and stays current on industry, company, and departmental methodologies, terminology, and regulations.