Job Description:

Position Title: Associate Director of Quality Assurance Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.We are working with an exciting clinical stage-bio pharmaceutical company. This position will involve: coordinating with Laboratory Operations Clinical Manufacturing, Analytics, Clinical and Regulatory departments to support their Quality Operations.Key responsibilities:Be able to manually maintain the Laboratory Operations and Quality System in addition to using electronic platforms.Complete vendor qualification and reevaluation; help with vendor management record maintenance as assigned.Create or update standard operating procedures (SOPs) and forms for laboratory operations, including material and equipment management and overall quality control.Maintain timely closure of quality records, including those pertaining to deviations, investigations, CAPA, change control, risk assessment and management, qualifications, validations, audits, and other QC/QA operations, by writing, reviewing, and following up on them.Conduct employee training in quality-related topics, such as inventory management, raw material qualification, quality control and maintenance, laboratory equipment qualification, and document control.Assist department leaders in keeping up-to-date laboratory technical training records.Create IQ OQ PQ protocols for lab equipment in collaboration with Laboratory Operations, then carry out their execution and/or evaluation.Complete essential raw material qualification records in collaboration with the manufacturing, analytics, and clinical laboratory departments.Acts as a fallback quality inspector for completed production batch records and related paperwork.Help with data entry and monitoring for quality metrics.Ensuring that master lists and periodic critical record reviews are current.Key Requirements:At least 2 years experience within a clinical laboratory setting and/or gene therapy manufacturing experience, within a quality settingUnderstanding of JACIE/FDA/FACT/CAP/AABB regulations and standardsExperience within inspections within clinical laboratory/and or cell and gene therapyProficient in lab-related electronic systems e.g LIMS, ELN , eQMS and eBRLocation:Located in or close to Birmingham AL (expect to be on-site in the lab at least 5 days a month)Please feel free to reach out to me via: 646-415-8221, ask for Edmund JonesOr by my email:ejones@