Quality Management Systems Associate

CareAbout•Cypress, CA

1d•$47,000 - $90,000

About The Position

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.

Requirements

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.

Nice To Haves

Bachelors degree, preferred.

Responsibilities

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.
Manage and resolve any software issues, including coordinating with the Master Control service provider to ensure timely resolutions and minimal disruptions.
Stay informed about updates to the Master Control application, assess their relevance, and implement necessary changes to maintain optimal system performance and compliance.
Serve as a resource for employees and the IT team, providing expertise, guidance, and technical support related to the Master Control system.
Continuously update personal skills, stay informed on technological advancements, and perform a technical-level watch to maintain expertise in system management.
Oversee proper documentation practices and version control within the Master Control system to ensure compliance with global regulatory standards and organizational policies.
Provide subject matter expertise during internal audits, external inspections, and audits, addressing questions related to the Master Control system and compliance practices.
Offer training, guidance, and support to users across departments, ensuring effective utilization of the Master Control system and fostering operational efficiency.
Collaborate with Quality Assurance and IT to validate system integrity, support regulatory compliance, and align with organizational quality objectives.
Handle multiple assignments simultaneously, effectively prioritize tasks, and meet strict deadlines while maintaining high standards of accuracy and efficiency.
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.
Identify and implement opportunities for system enhancements, process efficiencies, and compliance improvements to strengthen organizational performance.