Aditi Consulting · 21 hours ago
MCS Quality Assurance Specialist
Thousand Oaks, CA
Contract
Onsite
Entry Level
$40/hr - $43/hr
1+ years expAditi Consulting is seeking an MCS Quality Assurance Specialist to support the Quality Assurance program within the ATO Plant Quality Assurance organization. The role involves providing oversight of Commissioning, Qualification, and Validation (CQV) processes and ensuring compliance in various GMP areas.
AppsConsultingInformation TechnologySoftware Engineering
Responsibilities
Primarily responsible for ensuring adherence to equipment and computer validation standards and procedures
Responsibilities include participation in CQV design, review of test protocols, analysis of CQV results, and oversight of summary reports
Provides guidance and sets standards in producing quality documentation and serves as an advisor to Engineering, IS and Manufacturing functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT compliance issues
Executes quality oversight directly in Quality systems
Qualification
Required
Bachelor's degree in engineering, Biochemistry, Biology, Chemistry, or related science field
1+ YOE in Commissioning, Qualification, and Validation experience
Demonstrated ability to perform or provide oversight of GMP operations including following detailed SOPS, maintaining training, maintaining data integrity principles, and good documentation practices
Experience managing projects through completion while meeting timelines
Evaluating documentation and operations according to company procedures and related regulations
Experience working with Quality Systems
Strong organizational skills and ability to manage multiple tasks at one time
Effective communication skills (both written and verbal)
Demonstrated ability to work as both a team player and independently
Solid understanding and application of aseptic behaviors and principles
Commissioning, Qualification, and Validation experience
Experience with direct use of GMP quality systems (i.e. Deviation and Change Management, Equipment Maintenance and Lifecycle Management, Controlled Document Management systems)
Direct experience working or supporting GMP manufacturing, Facility and Engineering, or Quality Assurance teams within the biotech industry
Benefits
Medical
Dental
Vision benefits
10 paid days off
401(k) plan participation
Commuter benefits
Life and disability insurance
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
1001-5000 employees
H1B Sponsorship
Aditi Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (55)
2024 (44)
2023 (25)
2022 (26)
2021 (24)
2020 (30)
Funding
Current Stage
Late StageLeadership Team
Raja Narayana
President & CEO
Pradeep Singh
Chairman
Recent News
bloomberglaw.com
2025-10-16
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