Insight Global · 4 hours ago
Quality Control Analyst
Malvern, PA
Full-time
Onsite
Entry, Mid Level
$35/hr - $39/hr
2+ years expInsight Global is seeking a Quality Control Analyst to join their team. The QC CRS Analyst will be responsible for conducting biochemical testing of drug substances and ensuring compliance with applicable procedures and GMP regulations.
EmploymentHuman ResourcesRecruitingSales
Responsibilities
Conduct analytical biological testing (ELISAs, qPCR, Flow Cytometry, Cell-based assays, etc.) of clinical and commercial drug product/drug substance samples
Perform peer reviews and approvals of laboratory data
Use electronic systems (LIMS, MES, Empower, etc.) for execution and documentation of laboratory data
Support of New Product Initiatives (NPI) in groups of 3-6 analysts
Perform Instrument Calibration and/or Preventative Maintenance, as needed
Update CRS-owned documents using the Electronic Document Management System (EDMS)
Order/receive supplies and manage inventory
Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities
Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight
Complete invalid assay and general laboratory investigation records
Complete corrective and preventative actions (CAPA) as assigned
Assist in the execution of internal audits
Qualification
Required
Minimum two (2) years of relevant work experience
Experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry
Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)
Must have experience in the following: qPCR, cell culture, Flow Cytometry, and/or ELISA
Ability to read/interpret technical documents such as SOPs, work instructions, test methods and protocols
Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)
Benefits
Medical, dental, and vision insurance
HSA
FSA
DCFSA account options
401k retirement account access with employer matching
Paid sick leave
10 PTO Days
6 Sick Days
Company
Insight Global
Insight Global provides top talent and staffing solutions that help job seekers find careers in healthcare, finance, IT, and government.
1001-5000 employees
H1B Sponsorship
Insight Global 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 (281)
2024 (164)
2023 (75)
2022 (17)
2021 (3)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2010-07-01Acquired
Leadership Team
Jared Streppa
President Of Company’s Technology Division
Recent News
Maryland Daily Record
2025-09-26
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