SPECTRAFORCE · 9 hours ago
Quality Assurance Validation Specialist
SPECTRAFORCE is an organization supporting Quality Assurance programs, and they are seeking a Quality Assurance Validation Specialist. This role provides oversight of Commissioning, Qualification, and Validation processes in various GMP areas, ensuring compliance and supporting Manufacturing and Facilities & Engineering staff.
ConsultingCRMInformation TechnologyLegal
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 our organization's Quality systems
Qualification
Required
Bachelor's degree in engineering, Biochemistry, Biology, Chemistry, or related science field
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
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
H1B Sponsorship
SPECTRAFORCE 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)
Funding
Current Stage
Late StageCompany data provided by crunchbase