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. The Associate Quality Systems Manger is responsible for ensuring that all Quality System requirements are met, in conjunction with various regulations and accrediting bodies.
This is a full-time position.
Days and hours of work are Monday through Friday, 6:30 a.m. to 3:30 p.m. (assuming 1 hour lunch break)
- 100% Company-paid Medical, Dental and Vision Insurance
- Matching 401K Retirement Plan
- Phenomenal work environment working with some of the best people on the planet
- Free Lunches
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.
Position Duties...
- Supports the Quality Systems Manager in the implementation and review of Quality Systems policies and procedures.
- Conducts routine inspections of all labs to ensure compliance with Quality Systems policies and procedures.
- Conducts failure and near miss investigations and determines root cause.
- Implements corrective/preventative actions and continuous improvement activities.
- Functions as Systems Administrator for Electronic Quality Management System.
- Supervises at least one employee
- Responsible for various Quality System programs such as Audits (internal and external), Document Control, Training and Quality Events (Deviations, Change Control, CAPA and Risk Assessment).
- Provides training to employees such as new employee orientation and annual refresher training.
Position Requirements... - Bachelor’s degree or equivalent in Chemistry or Biology with...
- At least 3 years of experience in a laboratory setting
- Preferred Education and Experience...
- Bachelor’s degree in Chemistry or Biology with 2+ years’ experience in a regulated laboratory environment.
- Experience with OSHA, FDA, and DEA regulatory compliance as it relates to a laboratory setting.
- Experience ISO 17025 and 21 CFR part 211
- Ability to wear, maintain, and properly use appropriate safety equipment, including, but not limited to eye protection, gloves, and lab coat.
- Requires effective verbal and written communication skills, ability to interact constructively with peers/teams, and ability to seek outside resources as needed
- Basic knowledge of EHS best practices
- Strong PC skills in Microsoft Office (Word, Excel and PowerPoint)
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...
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.
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.