Job Description

Job Title: QA Quality Systems

Location: Torrance

Pay: $30-38

JOB DESCRIPTION:

This company , is seeking a motivated Computerized System Sr. Specialist to join our Quality Assurance team. In this key role, you will drive success and improvement by effectively implementing global computerized system procedures. This role must be quality-focused and understand FDA regulations, Quality Management Systems, Good Manufacturing Practices, GAMP 5, and 21 CFR Part 11 (Electronic Records and Signatures). The Computerized System Sr. Specialist is responsible for the oversight of computerized systems activities, such as review and approval of IQ/OQ/PQ, including maintenance of GxP software, such as audit trail review, user account management, electronic data integrity, system configuration, and data backup and recovery. You will collaborate with Production, Quality Control, Engineering, Validation, IT/IS, and the Global team to ensure GxP systems are implemented, maintained, and compliant across the organization.

PRIMARY RESPONSIBILITIES:

• Primary point of contact for all quality issues related to computerized systems.
• Identify, communicate, and execute value-added process improvements/initiatives.
• Collaborate with cross-functional teams to develop technical requirements for computerized systems aligning with regulatory requirements, industry best practices, and company policies.
• Provide guidance in defining technical requirements for computerized systems and support system owners with risk assessments and system impact assessment activities.
• Data integrity, compliance, and inspection readiness lead for site computerized systems platforms
• Assists with planning and conducting internal compliance audits of all operations within the facility. Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Participate in audit preparation, interim/self-inspections, and client/externally initiated audits.
  
  

KNOWLEDGE, SKILLS & ABILITIES:

• Knowledge in FDA, GDP, cGMPs (21 CFR, 210/211, 820, and ICH Q7)
• Ability to effectively present information to management and/or peers.
• Comfortable working independently and with individuals in other departments across the organization.
• Strong verbal and written communication skills – ability to communicate effectively at all levels of the organization.
  
  

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people
  
  

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

Job Tags

Full time, Interim role,

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