Quality Management Systems Associate

About the role

The Quality Management System Associate is responsible for administering and maintaining the Master Control system to support compliance across GxP (GCP, GLP, and GMP) environments. This role ensures the system operates in alignment with global regulatory, privacy, ethics, and compliance requirements, facilitating proper documentation, version control, and traceability.

Responsibilities

• System Administration and Maintenance
• Issue Management and Provider Collaboration
• Application Updates
• Employee and IT Resource Support
• Skills and Technology Advancement
• Documentation and Compliance
• Audit and Inspection Expertise
• Cross-Departmental Collaboration
• IT and QA Partnership
• Workload Management
• Business Relationship Development
• Continuous Improvement

Requirements

• Bachelor's degree, preferred.
• Ability to read and interpret documents such as operating instructions, and technical procedure manuals.
• Ability to write routine reports, standard operating procedures, and basic business correspondence.
• Ability to speak effectively before groups of customers or employees of organization, sponsors, participants, vendors, monitors.
• Excellent organizational, interpersonal and leadership/teamwork abilities.
• Communicate and work with a very broad spectrum of professional and technical staff to effectively manage documents and records in an efficient and practical manner.
• Proficient experience with Master Control.
• 1 - 4 years of experience and understanding of Quality in the pharmaceutical/health care industry, preferred.
• Proficient knowledge of GxPs, regulatory, privacy and compliance requirements.
• Good problem-solving skills, and ability to make decisions.
• Project Management or Computer System Validation experience, preferred, or equivalent combination of education and experience.

Qualifications

• Ability to write routine reports, standard operating procedures, and basic business correspondence.
• Ability to speak effectively before groups of customers or employees of organization, sponsors, participants, vendors, monitors.
• Excellent organizational, interpersonal and leadership/teamwork abilities.
• Communicate and work with a very broad spectrum of professional and technical staff to effectively manage documents and records in an efficient and practical manner.
• Proficient experience with Master Control.
• 1 - 4 years of experience and understanding of Quality in the pharmaceutical/health care industry, preferred.
• Proficient knowledge of GxPs, regulatory, privacy and compliance requirements.
• Good problem-solving skills, and ability to make decisions.
• Project Management or Computer System Validation experience, preferred, or equivalent combination of education and experience.

Skills

• Master Control
• Quality in the pharmaceutical/health care industry
• GxPs, regulatory, privacy and compliance requirements
• Problem-solving skills
• Project Management or Computer System Validation experience

Benefits

• Salary range: $47,000 - $90,000
• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs

Pay

The salary range estimated for this position is $47,000 - $90,000. Please note that salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.

Schedule

Not specified.