Avid Bioservices · 1 day ago
Data Reviewer, Quality Control
Tustin, CA
Full-time
Onsite
Mid Level
$26.73/hr - $35.62/hr
4+ years expAvid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of clients and improve patient outcomes. The Data Reviewer, Quality Control will primarily review Quality Control analytical data to ensure compliance with regulations and protocols. This role involves evaluating QC data, supporting investigations, and conducting reviews to maintain quality standards.
BiotechnologyHealth CareMedical
Responsibilities
Conduct a comprehensive and critical evaluation on QC data in Empower and SoftMax Pro software including but not limited to contents, results, data accuracy, and scientific relevance, format and adherence to cGMPs
Perform a thorough review of raw data, including electronic raw data and documentations to ensure compliance with applicable specifications and/or protocols
Conduct GMP review of laboratory notebooks, logbooks, and associate forms
Conduct GMP review of electronic raw data to ensure compliance with data integrity policies
Support OOS/OOT investigations
Support internal and external audit
Support QC method validation review, as needed
Perform review of procedural and method revisions, where necessary
Perform other duties as assigned to support Quality activities
Qualification
Required
Bachelor's degree, preferably in a life sciences field (such as biology, microbiology, biochemistry, chemistry)
4+ years' work experience in a GMP/biopharmaceutical/pharmaceutical manufacturing environment
Experience with Empower and SoftMax Pro software
Knowledge of cGMPs, pharmacopeia and compendial requirements
Experience in and knowledge of 21 CFR data integrity requirements
Familiarity with analytical testing methods and validation including laboratory instrumentation
Strong verbal and written communication skills
Familiarity with laboratory computerized systems such as Empower and LIMS
Proficient with Microsoft applications
Benefits
Health, dental, and vision insurance
401(k) matching
Paid time off
Company
Avid Bioservices
Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine.
201-500 employees
H1B Sponsorship
Avid Bioservices 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 (2)
2024 (1)
2023 (1)
2022 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$285M2024-11-06Private Equity
2024-11-06Acquired
2024-03-06Post Ipo Debt· $160M
Leadership Team
Kenneth Bilenberg
President & Chief Executive Officer
Recent News
2025-11-13
2025-11-10
Company data provided by crunchbase