GLP Quality Assurance Manager, Bioanalytical Lab - NorthEast BioAnalytical Laboratories LLC : Job Details
GLP Quality Assurance Manager, Bioanalytical Lab
NorthEast BioAnalytical Laboratories LLCJob Location : Hamden,CT, USA
Posted on :
2025-08-07T01:10:18Z
Job Description :
GLP Quality Assurance Manager, Bioanalytical Lab – Hamden, CT, USAEnsure 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 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 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 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 #J-18808-Ljbffr
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