Quality Management System Administrator

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):
  Duties/Responsibilities1Primary 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 guidelines2Coordinates 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 lifecycle3Conducts final Quality review of GMP documentation in the learning Management System4Responsible for report generation within QMS/learning Management System 5Assists with maintenance of master software/systems/assets spreadsheet6Assists in evaluation of Quality department metrics and performance against those metrics7Responsible for assisting with quality initiatives and acting as a change agent in the organization8Collaborates with various teams to establish and enhance quality processes as related to the QMS and Record Retention9Participates in continuous improvement activities in the Quality department10Other duties as required
Reporting to this Position:
No direct reports
Travel:
Position may require 0-5% travel
Work 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

Education and Experience:

• 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

Physical Demands and Work Environment:    

• 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)

GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies.  The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position.  It is not intended to be an exhaustive list of all duties, responsibilities, and skills required.  The position may require other duties as assigned and can be changed at any time by the company.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.