1 Quality Management System Administrator Job in Blue, OH
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Quality Management System Administrator
$76k-94k (estimate)
Full Time | Pharmaceutical
6 Months Ago
Aprecia Pharmaceuticals is Hiring a Quality Management System Administrator Near Blue, OH
General Purpose of Position:This position is primarily responsible for collaborating with all departments to help with coordination, creation, and implementation of processes and procedures to ensure that site quality compliance requirements are being followed at Aprecia Pharmaceuticals.Primary Duties and Responsibilities (Essential Functions):
Reporting to this Position:No direct reportsTravel:Position may require 0-5% travelWork Shift:This position works days Knowledge, Skills and Abilities:
| Duties/Responsibilities | |
| 1 | Primary administrator of Aprecia’s Quality Management System (QMS); Functions as the in-house expert for all QMS modules (Documentation, Training, and Electronic Batch Records) to ensure the QMS maintains compliance with industry expectations and regulatory guidelines |
| 2 | Coordinates activities in conjunction with Quality Management to ensure all GMP-related documentation is maintained in accordance with the site Record Retention Policy throughout the entire documentation lifecycle |
| 3 | Conducts final Quality review of GMP documentation in the learning management system |
| 4 | Responsible for report generation within QMS/learning management system |
| 5 | Assists with maintenance of master software/systems/assets spreadsheet |
| 6 | Assists in evaluation of Quality department metrics and performance against those metrics |
| 7 | Responsible for assisting with quality initiatives and acting as a change agent in the organization |
| 8 | Collaborates with various teams to establish and enhance quality processes as related to the QMS and Record Retention |
| 9 | Participates in continuous improvement activities in the Quality department |
| 10 | Other duties as required |
Reporting to this Position:No direct reportsTravel:Position may require 0-5% travelWork Shift:This position works days Knowledge, Skills and Abilities:
- Working knowledge of cGMPs within the pharmaceutical industry
- Great attention to detail
- Strong written, verbal and interpersonal skills
- Ability to manage multiple projects simultaneously
- Ability to learn and adapt to demands in a fast-paced work environment
- Excellent prioritization and organizational skills
- Proficient in both written and verbal communication
- Understanding of databases and data structure
- Ability to perform major day-to-day administrative hands-on tasks
- Demonstrated ability to understand Quality issues and collaborate with other departments to drive scientifically sound and compliant resolutions
- Skilled at using MS Office Word, Excel and PowerPoint; Power BI experience a plus
- B.S. degree in a scientific discipline or equivalent required or equivalent combination of education and experience
- Minimum 3 years of experience in the pharmaceutical industry required
- Familiar with the fundamentals of document management and the management of the document life cycle
- Previous experience with a quality management software platform
- Good eyesight to create, read, and interpret documentation
- Extended viewing of computer screens and manual dexterity to operate office computer, keyboard and other general office equipment
- Ability to sit at a desk for extended periods of time
- Ability to walk or stand for extended periods of time
- Lifting of boxes (less than 25 pounds) containing documentation
- Bending, squatting and/or kneeling while accessing files and performing other job duties
- Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (i.e. respirators, over-gowning, gloves, steel toe shoes)
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$76k-94k (estimate)
POST DATE
10/09/2023
EXPIRATION DATE
05/04/2024
WEBSITE
aprecia.com
HEADQUARTERS
EAST WINDSOR, NJ
SIZE
100 - 200
FOUNDED
2004
TYPE
Private
CEO
PAT ZAFARINO
REVENUE
$5M - $10M
INDUSTRY
Pharmaceutical
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About Aprecia Pharmaceuticals
Aprecia Pharmaceuticals develops, manufactures and commercializes precision drug delivery systems and other related products.
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