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Form of workQuality and Safety Systems Specialist
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 Quality and Safety Systems Specialist directs and leads efforts in Quality Systems, and Safety and Risk Management that will include oversight of various activities including Audits, Document Control, Training, Quality Events and Proficiency Testing.
Some highlights...
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 Quality and Safety Systems Specialist directs and leads efforts in Quality Systems, and Safety and Risk Management that will include oversight of various activities including Audits, Document Control, Training, Quality Events and Proficiency Testing.
Some highlights...
- 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.
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.
Essential Functions…
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.
Essential Functions…
- Supports the Director of Quality Assurance in the implementation and review of Quality Systems policies and procedures.
- Conduct routine inspections of all labs to ensure compliance with Quality Systems policies and procedures.
- Conduct failure and near miss investigations and determine root cause.
- Implements corrective/preventative actions and continuous improvement activities.
- Systems Administrator for the Electronic Quality Management System.
- 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.
- Ability to wear, maintain, and properly use appropriate safety equipment, including, but not limited to eye protection, gloves, and lab coat.
Position Requirements...
- Bachelor’s degree in chemistry or biology with 5+ years of applicable experience in the pharmaceutical industry.
- Experience with FDA 21 CFR part 11 and 211, as well as ICH and USP requirements as it relates to the pharmaceutical industry.
- Experience with ISO 17025:2017 general requirements for the competence of testing and calibration laboratories.
- Strong organizational and time management skills to balance working on multiple projects.
- Independently motivated, detail oriented and good problem solving ability.
- Requires effective verbal and written communication skills, ability to interact constructively with peers/teams, and ability to seek outside resources as needed.
- Strong PC skills in Microsoft Office (Outlook, Word, Excel, and PowerPoint)
Work Environment...
This job operates in an office and laboratory environment.
Physical Demands...
The role requires standing and/or setting for prolonged periods of time; dexterity in fingers and hands to perform complex and precise manipulations; ability to walk and stoop; ability to lift and move up to 50 pounds; see in the normal visual range including the ability to distinguish colors and shades and hear in the normal audio range with or without correction.
