System Associate Jobs in Irvine, CA (NOW HIRING)

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At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.

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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

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!