Quality Systems Analyst
Quality Systems Analyst
Posted on :
18-04-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
18-04-2025
Job Description
Required Education and Experience
Position Summary...
ARL Bio Pharma is the leading Pharmaceutical testing laboratory in the nation with an unparalleled reputation for quality science. The Quality Systems Analyst is responsible for ensuring that all Quality System requirements are met in conjunction with various regulations and accrediting bodies.
Position Summary...
ARL Bio Pharma is the leading Pharmaceutical testing laboratory in the nation with an unparalleled reputation for quality science. The Quality Systems Analyst is responsible for ensuring that all Quality System requirements are met in conjunction with various regulations and accrediting bodies.
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. is one of the substances included in the drug panel screening. Possession of a medical license will not excuse you from the testing process or the consequences of testing positive for .
Work Schedule: This is a fulltime position. Days and hours of work are Monday through Friday 8:00 a.m. to 4:30 p.m. (assuming 30minute lunch break)
- 100 Companypaid medical dental and vision insurance
- Companymatched 401K retirement
- Generous paid time off and holidays
- Free lunch every day
- Opportunity to work in a great environment with amazing people
Job Duties...
- Supports the Quality Department EHS and Facilities in the implementation and review of Quality Systems policies and procedures.
- Responsibility for completing routine workload in MasterControl including document control review editing release general troubleshooting training files employee or client onboarding/offboarding etc.
- Responsibility for issuing all Deviation Report CAPA Change Control & Risk Assessment numbers upon email request and maintaining the number index for each in realtime.
- Responsibility for reviewing and completing Deviation Reports on casebycase basis.
- Assists with follow up communication of Deviation Reports CAPA reports Change Controls as needed.
- Responsibility of running weekly reports to update QA dept metrics for the Traction meeting.
- Assists with Client Audit preparation documentation preaudit walkthrough review of laboratory areas and pulling documentation per request during the Audit.
- Assists with Internal Audit documentation walkthrough review of laboratory areas and pulling documentation for review during the Internal Audit.
- Support any other QA department initiatives as needed.
- Ability to wear maintain and properly use appropriate safety equipment including but not limited to eye protection gloves and lab coat.
Position Requirements...
Associates degree or equivalent in Chemistry or Biology (or)
At least 12 years of experience in a laboratory setting
Bachelors degree in Chemistry or Biology with 1 year experience in a regulated laboratory environment. is preferred
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.
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...
Speaking listening sitting writing visual acuity lifting: The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. 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.
Position Type/Expected Hours of Work
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.
Required Experience:
IC
Employment Type
Full Time
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