Quality Assurance Specialist

Amador Bioscience
Germantown, MD
Dec 05, 2022
Dec 08, 2022
IT, QA Engineer
Full Time
A$ A' "A' ?Position SummaryAmador Bioscience is a Translational & Clinical Pharmacology CRO providing global-standard services in quantitative clinical pharmacology, GLP/GCLP bioanalysis, clinical research, and regulatory filing to leading biopharmaceutical companies. Our clients include multinational pharmaceuticals and mid- and small-size biotech companies. Reporting directly to the Quality Assurance Manager, the position is responsible for supporting quality systems covering pre-clinical studies (GLP) and laboratory clinical (GCLP) testing activities.Role and ResponsibilitiesAuthors and/or reviews Standard Operating Procedures (SOPs).Assure regulatory requirements are met by auditing the protocol, raw data, data summary tables, draft and final reports associated with nonclinical studies or bioanalytical sample analysis protocols.Audit IQ, OQ, PQ, of, software, computerized systems, or laboratory equipment validation reports.Plan, conduct and report inspections of the internal bioanalytical laboratory.Plan, conduct and report audits of external Laboratory Clinical or Non-clinical Laboratory Study and bioanalytical laboratories to assess compliance with regulatory standards.Assure QA department inspection reports and any other supporting documentation or required records are appropriately retained, processed and archived, as appropriate.Identify regulatory compliance issues and provide regulatory support to departments.Provide local oversight (ie, tertiary review) and elevate all serious issues to the Director of Quality Assurance.Provide QA support for risk assessment and remediation, and identification and investigation/CAPA of deviations.Represent QA on local project and test site meetings. Ability to travel domestically and internationally - approximately 10-15%.Qualifications and Education RequirementsBachelor's degree in a scientific discipline (ie, Biology, Chemistry, etc.) including a minimum of 4 years' QA experience auditing in a GLP or GCLP environments, or QC of bioanalytical data. Experience auditing in a GLP bioanalytical laboratory is preferred.Excellent verbal or written communication skills with the ability to interact with all levels of employees.Must have excellent attention to detail and time management skills as well as the ability to manage multiple priorities with aggressive timelines and changing priorities.Preferred SkillsExcellent understanding of GLP and GCLP for FDA and applicable international regulations.Ability to embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.Experience in conducting detailed external and internal audits.RQAP-GLP, or other applicable certification or registration preferred.Experience supporting GCP clinical sample analysis audits.Experience conducting assays in a bioanalytical laboratory.Strong emotional intelligence and ability to build relationships with internal and external stakeholders.