GLP Quality Assurance Manager, Bioanalytical Lab

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