Position Summary...
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.
Essential Functions...
- 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.
Minimum Position 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.
Preferred Qualifications:
Work Environment...
- This job operates in a professional office environment using typical office equipment (scanners, printers, computers, phones).
- The noise level is moderate to loud.
- Exposure to dust and fumes.
- Exposure to the use of chemicals with the classification of Hazardous, Toxic, Corrosive, Flammable, or Oxidizing.
- Primarily dominated English-speaking workplace.
- Attendance at the office is required.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
Physical Requirements...
- This is an active role with occasional walking between buildings daily. This position is a partially sedentary role, and some filing is required.
- Ability to sit and stand in front of a computer for extended periods, with intermittent twisting/bending to reach instruments or supplies surrounding equipment.
- This position would require the ability to lift 50 Lbs. (if an object weighs more than 50 Lbs. ARL requires this to be a two-person job or the use of carts.
- Ability to use hand strength and finger dexterity to perform fine manipulations of tool equipment, including turning, pressing, twisting, and typing.
- Must be able to wear Personal Protective Equipment (PPE).
- Must be fluent in written and spoken English to receive and communicate information for standard and complex operations and emergencies clearly and accurately.
- Requires visual acuity to read and write words and numbers, and to see in the normal visual range, including the ability to distinguish colors with or without correction.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus with or without correction.
- Requires hearing communications accurately with or without correction.
- Work Restrictions:
- Because of the vital nature of this work, we do not allow medical marijuana cards, and we do random drug testing on all our employees.
- The Company is subject to certain federal regulations and directives regarding a drug-free workplace. Because of the Company’s federal obligations and directives, as an employee of an analytical laboratory such as ARL Bio Pharma Inc., 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.
