Collabera · 2 days ago
Senior Specialist, Lab Services
Collabera is seeking a Senior Specialist in Lab Services to provide quality assurance and compliance support for quality control laboratory operations within a regulated environment. This role focuses on ensuring that laboratory systems, equipment, documentation, and processes meet regulatory and internal quality standards while collaborating with cross-functional teams on compliance initiatives and audits.
Responsibilities
Serve as a compliance specialist for quality control laboratories, performing routine assessments and communicating compliance findings to laboratory leadership
Coordinate laboratory audits and ensure completion of required compliance reviews and data integrity checklists
Support review of compendial changes and assess laboratory impact, including assignment of verification activities
Act as calibration coordinator, managing service requests, maintenance scheduling, and instrument qualification impact assessments
Collaborate with cross-functional teams to support procurement, installation, calibration, and qualification of laboratory instrumentation
Review laboratory documentation to assess compliance with quality systems and regulatory requirements and identify improvement opportunities
Lead planning, preparation, review, and approval of quality documentation related to laboratory and calibration activities
Participate in equipment qualification and validation review activities as a laboratory representative
Support development, revision, and implementation of quality procedures and training materials for laboratory personnel
Qualification
Required
Bachelor's degree in Chemistry, Biology, Microbiology, Engineering, or a related scientific discipline
Six or more years of experience working in a regulated laboratory environment supporting quality or compliance activities
Strong experience with documentation review in a quality-controlled environment
Hands-on experience using Empower, laboratory information management systems, and electronic lab notebooks
Solid understanding of good manufacturing practice regulations and quality systems
Strong written and verbal communication skills with the ability to collaborate across teams
Preferred
Experience supporting quality control laboratory operations within pharmaceutical or biotechnology environments
Familiarity with laboratory instrumentation, calibration processes, and qualification activities
Experience leading or coordinating cross-functional projects or initiatives
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually – as applicable
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
H1B Sponsorship
Collabera 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 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Recent News
2024-04-09
2023-01-20
2022-04-19
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