Quality Management Systems Associate

Altasciences; Cypress (CA); On-site; USD 47,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

401(k) / RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Job summary

Altasciences is hiring a Quality Management Systems Associate in Cypress, CA. The role administers the Master Control system to ensure GxP compliance, regulatory alignment, and proper documentation.

You will collaborate with QA and IT, support users across departments, implement updates, and drive continuous improvement in quality systems and processes.

Qualifications

• Bachelor's degree preferred.
• Ability to read and interpret documents and write routine reports.
• Ability to speak effectively before groups of customers or employees.
• Ability to work effectively in geographically dispersed cross-functional teams.
• Excellent organizational, interpersonal and leadership/teamwork abilities.
• Proficient knowledge of Master Control.
• 1-4 years of experience in pharma/healthcare quality.
• Knowledge of GxP, regulatory/privacy/compliance requirements.
• Strong problem-solving and decision-making skills.
• Project Management or Computer System Validation experience preferred.

Responsibilities

• Administer and maintain the Master Control system supporting GxP compliance.
• Coordinate with Master Control service provider for issue resolution.
• Update and implement Master Control app updates as needed.
• Provide guidance and technical support to employees and IT teams.
• Stay informed on system advances and maintain expertise in system management.
• Oversee documentation practices and version control within Master Control.
• Support internal audits and external inspections related to Master Control.
• Train and support cross-department users to ensure proper usage of the system.
• Collaborate with QA and IT to validate system integrity and regulatory alignment.
• Manage multiple tasks with tight deadlines while maintaining accuracy.

Skills

Leadership

Cross-functional teamwork

Communication

Organizational skills

Problem-solving

Education

Bachelor's degree

Tools

Master Control

Job description

## Quality Management Systems AssociatePostulerremote type: A distancelocations: Cypress, Californiatime type: Temps pleinposted on: Publié aujourd'huijob requisition id: R102786**Votre nouvelle entreprise !** Chez Altasciences, nous travaillons tous à l'unisson pour contribuer à la découverte, au développement et à la fabrication de nouvelles thérapies médicamenteuses afin qu'elles parviennent plus rapidement aux personnes qui en ont besoin. Quel que soit votre rôle, nous jouons tous un rôle important et vous aurez un impact significatif sur la santé et le bien-être des personnes dans le monde entier. En respectant nos valeurs de développement du personnel, d'orientation client, de qualité et d'excellence, de respect et d'intégrité, nous cherchons à favoriser un environnement de travail passionné et collaboratif et nous sommes à la recherche de personnes talentueuses et enthousiastes, comme vous, pour rejoindre notre équipe en pleine croissance ! Que vous soyez un récent diplômé de l'université ou à la recherche de votre prochaine opportunité de carrière, il est temps de découvrir votre avenir chez Altasciences.Nous sommes meilleurs ensemble et c'est ensemble que nous sommes Altasciences.**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. The individual will collaborate with Quality Assurance to uphold system integrity, provide cross-departmental support to users, and ensure the system is effectively utilized to meet organizational objectives. This position plays a critical role in fostering compliance, operational efficiency, and adherence to the company’s overarching quality and regulatory standards.**What You’ll Do Here*** System Administration and Maintenance: Administer and maintain the Master Control system to support GxP (GCP, GLP, and GMP) compliance, ensuring its effective operation and alignment with global regulatory, privacy, ethics, and compliance requirements.* Issue Management and Provider Collaboration: Manage and resolve any software issues, including coordinating with the Master Control service provider to ensure timely resolutions and minimal disruptions.* Application Updates: Stay informed about updates to the Master Control application, assess their relevance, and implement necessary changes to maintain optimal system performance and compliance.* Employee and IT Resource Support: Serve as a resource for employees and the IT team, providing expertise, guidance, and technical support related to the Master Control system.* Skills and Technology Advancement: Continuously update personal skills, stay informed on technological advancements, and perform a technical-level watch to maintain expertise in system management.* Documentation and Compliance: Oversee proper documentation practices and version control within the Master Control system to ensure compliance with global regulatory standards and organizational policies.* Audit and Inspection Expertise: Provide subject matter expertise during internal audits, external inspections, and audits, addressing questions related to the Master Control system and compliance practices.* Cross-Departmental Collaboration: Offer training, guidance, and support to users across departments, ensuring effective utilization of the Master Control system and fostering operational efficiency.* IT and QA Partnership: Collaborate with Quality Assurance and IT to validate system integrity, support regulatory compliance, and align with organizational quality objectives.* Workload Management: Handle multiple assignments simultaneously, effectively prioritize tasks, and meet strict deadlines while maintaining high standards of accuracy and efficiency.* Business Relationship Development: Build and maintain strong business relationships with internal stakeholders, the Master Control service provider, and relevant external partners to ensure seamless operations and continuous improvement.* Continuous Improvement: Identify and implement opportunities for system enhancements, process efficiencies, and compliance improvements to strengthen organizational performance.**What You’ll Need to Succeed*** Bachelors 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* Ability to work effectively in geographically dispersed cross-functional teams.* Excellent organizational, interpersonal and leadership/teamwork abilities* Ability to 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.**What We Offer**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. Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.**Altasciences’ Benefits Package Includes:*** Health/Dental/Vision Insurance Plans* 401(k)/RRSP with Employer Match* Paid Vacation and Holidays* Paid Sick and Bereavement Leave* Employee Assistance & Telehealth Programs**Altasciences’ Incentive Programs Include:*** Training & Development Programs* Employee Referral Bonus Program#LI-AN1