GLP Quality Assurance Manager, Bioanalytical Lab

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