NorthEast BioLab · 2 months ago
GLP Quality Assurance Manager, Bioanalytical Lab
Hamden, CT
Full-time
Onsite
Mid, Senior Level
2+ years expNorthEast BioLab is a company specializing in bioanalytical services, and they are seeking a GLP Quality Assurance Manager to ensure high-quality, compliant data for bioanalysis projects. The role involves leading audits, reviewing study documentation, and maintaining regulated documents while fostering client relationships and supporting business development activities.
Health CareLife Science
Responsibilities
Ensure high-quality, compliant GLP and non-GLP data for LC-MS/MS and HPLC-UV OR ELISA, MSD, Luminex, and qPCR, bioanalysis projects
Host Regulators, Sponsors, Potential Clients, and Lead Audit/Inspection Response Team
Review all study documentation covering method development, validation, and sample analysis for drug and biomarker bioanalysis of customized Chromatographic and Ligand Binding Assay
Perform/document QA audits and facility inspections, in-life and otherwise, plus monitor lab activities plus against SOPs, method validation plans, study protocols, and FDA/ICH/EMA guidelines
Maintain controlled, indexed regulated documents (e.g., Study and Method Registers, GLP Master Schedule, etc), archive onsite (including electronic), and send to (and retrieve from) off-site archive
Author, review, and maintain SOPs, report templates, training plans, annual regulatory refresher training, data trending reports, etc
Track, trend, and ensure quality and compliance of Corrective Action/Preventative Action (CAPA), Investigations, Deviations, and Change Controls
Review computerized system validations, equipment maintenance, and calibration records
Conduct assessments and handle information requests for clients, potential clients, suppliers and vendors, test facilities, clinical sites, etc
Assist with maintaining current facility certificates and registrations, controlled substances, and safety program documentation
Support management and business development or marketing activities, foster client relationships, and onboard new clients
Qualification
Required
QA Candidates with small or large molecule bioanalytical experience in a deadline-driven and regulated GxP setting
Knowledgeable in US FDA 21 CFR Part 58 (GLP), Part 11 Regulations and 2003 Guidance, FDA 2018 BMV Guidance, OECD GLP, US FDA & ICH GCP, EMA requirements, etc
BS (3+ years experience) or MS (2+ years) degree in analytical chemistry, biochemistry, pharmacology, biotechnology, biomedical sciences, or related areas
Hands-on experience with Sciex Mass Spectrometers and Analyst software, or ELISA, MSD, Luminex, and qPCR Assay platforms is a huge plus
Excellent interpersonal communication and relationship building where all feel heard and respected
Fast and continuous learner, flexible thinker, self-motivated doer who can independently manage responsibilities, take on new challenges, mentor and train others, and with demonstrated ability to thrive in a fast-paced environment
Familiarity with Thermofisher's Watson LIMS, Non-compartmental Analysis (NCA) on Certara's WinNonlin, GMP, and CAP/CLIA regulations is desirable
Proficient in Microsoft Office, Adobe Programs plus scientific and technical reading and writing
Benefits
Competitive compensation commensurate with industry experience
Discretionary performance bonus and equity participation at year-end
Two weeks paid annual vacation
401k match and healthcare coverage to eligible employees
Accelerated career progression with flexibility to expand role and grow into the next level
Company
NorthEast BioLab
Bioanalytical lab with 15+ years experience in GLP and clinical bioanalysis services for drug and biomarkers.
11-50 employees
H1B Sponsorship
NorthEast BioLab 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 (3)
2023 (3)
2022 (3)
2021 (2)
Funding
Current Stage
Early StageTotal Funding
unknown2025-08-06Acquired
Leadership Team
Vipin Agarwal
President & CEO
Recent News
2025-08-13
Hartford Business Journal
2025-08-08
2025-08-07
Company data provided by crunchbase