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      • Business Development Associate
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Expertise

  • Menu IconAll Expertise
    • Menu IconMass Spectrometry (LC-MS)
      • Menu IconMass Spectrometry Services
      • Menu IconHPLC Testing Services
    • Menu IconMeso Scale Discovery Assay
      • Menu IconELISA Assay
        • Menu IconLuminex Multiplex Assay
      • Menu IconFlow Cytometry
        • Menu IconqPCR Analysis, ddPCR Assay
          • Menu IconWestern Blot, In Cell Western

            Services

            • Menu IconAll Services
              • Menu IconPharmacokinetics (PK) Study
                • Menu IconToxicology (Tox) Study
                • Menu IconDose Formulation Analysis
                • Menu IconPK PD Analysis
                • Menu IconDrug Metabolism and Pharmacokinetics (DMPK)
                • Menu IconADME Studies
                • Menu IconBioequivalence and Bioavailability Studies
              • Menu IconADA Assay, Neutralizing Antibody Assay
                • Menu IconMultiplex Cytokine Assay
                  • Menu IconBiomarker Assay
                    • Menu IconBiomarker Assay List
                  • Menu IconCell-Based Assay
                    • Menu IconMechanism of Action (MOA) Studies
                    • Menu IconCytotoxicity Assay
                    • Menu IconBiochemical Assay
                  • Menu IconBioanalytical Assay Validation

                    Solutions

                    • Menu IconAll Solutions
                      • Menu IconClinical CRO
                        • Menu IconCentral Lab Services
                        • Menu IconPBMC Services
                      • Menu IconGLP Laboratory
                        • Menu IconBioanalysis
                        • Menu IconNon-GLP Testing
                      • Menu IconPreclinical CRO
                        • Menu IconMethod Development, Validation, And Transfer
                          • Menu IconMethod Validation
                          • Menu IconMethod Development
                          • Menu IconMethod Transfer
                        • Menu IconAnalytical Testing
                          • Menu IconDiscovery Screening Services
                          • Menu IconAnalytical Quantitation
                          • Menu IconCosmetic Testing

                        About Us

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                                  • Menu IconTherapeutic Areas
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                                              • Menu IconBusiness Development Associate
                                              • Menu IconSr. Scientist – Cell Based Assay
                                              • Menu IconGLP Quality Assurance Manager
                                              • Menu IconSr. Scientist, ELISA Immunoassay Bioanalysis
                                              • Menu IconSr. Scientist, LC-MS/MS Bioanalysis
                                              • Menu IconAssociate Scientist, Central Laboratory Services
                                              • Menu IconSr. Scientist - Pharmacokinetics (PK)
                                              • Menu IconContent Manager, Scientific and Regulatory Writing

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                                            • Menu IconLearning Center
                                              • Menu IconBlog
                                                • Menu IconCase Study
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                                                            • Home
                                                            • GLP Quality Assurance Manager, Bioanalytical Lab

                                                            GLP Quality Assurance Manager, Bioanalytical Lab – Hamden, CT, USA

                                                            NOTE: PLEASE SUBMIT BOTH RESUME AND COVER LETTER TO APPLY FOR THIS JOB. KINDLY DISCUSS YOUR MOTIVATION, RELEVANT EXPERIENCE, SALARY REQUIREMENTS, AND VISA STATUS IN YOUR SUBMISSION.

                                                            Role

                                                            • 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

                                                            Qualifications

                                                            • 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

                                                            Compensation And 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

                                                            Industry

                                                            • Biotechnology
                                                            • Pharmaceuticals
                                                            • Outsourcing/Offshoring

                                                            Employment Type

                                                            • Full Time

                                                            If interested, please e-mail your resume to careers@nebiolab.com.

                                                            Contact A Scientist With Your Bioanalytical Study Details

                                                            We Will Respond Within 1 Business Day

                                                            Expertise

                                                            Expertise

                                                            • Mass Spectrometry (LC-MS)
                                                            • Meso Scale Discovery Assay
                                                            • ELISA Assay
                                                            • Flow Cytometry
                                                            • qPCR Analysis, ddPCR Assay
                                                            • Western Blot, In Cell Western

                                                            Services

                                                            Services

                                                            • Pharmacokinetics (PK) Study
                                                            • ADA Assay, Neutralizing Antibody Assay
                                                            • Multiplex Cytokine Assay
                                                            • Biomarker Assay
                                                            • Cell-Based Assay
                                                            • Bioanalytical Assay Validation

                                                            Solutions

                                                            Solutions

                                                            • Clinical CRO
                                                            • GLP Laboratory
                                                            • Preclinical CRO
                                                            • Method Development, Validation, And Transfer
                                                            • Analytical Testing

                                                            About Us

                                                            About Us

                                                            • Overview
                                                            • Leadership
                                                            • Facility and Equipment
                                                            • Quality and Compliance
                                                            • Therapeutic Areas
                                                            • Why Us?
                                                            • Values
                                                            • Process
                                                            • Partners
                                                            • Careers

                                                            Resources

                                                            Resources

                                                            • Learning Center
                                                            • Blog
                                                            • Case Study
                                                            • Video Brochures
                                                            • News and Events
                                                            • Testimonials
                                                            • Contact Us
                                                            NorthEast BioLab Logo Agile Bioanalytical Services CRO
                                                            sales@nebiolab.comFollow Up On Email
                                                            (203) 361 3780Follow Up On Phone

                                                            35 Worth Ave, Hamden, CT 06518

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