Quality Assurance Specialist IV
AstraZeneca Pharmaceuticals LP
TITLE: Quality Assurance Specialist IV
LOCATION: Frederick, MD
HOURS: 12 hour/Night (6:00pm to 6:30am) for three nights (Saturday, Sunday and Monday)
DUTIES: Act as team lead assisting the supervisor. Responsible for assuring the quality of commercial and clinical products manufactured at the facility. Support functional areas including manufacturing, facilities and other Quality departments. Implement quality policies for process improvements; change management utilizing risk-based approach; and electronic system usage with tools such as PAS-X. Author documents and participate in change review of SOPs. Assist in the management of identified projects impacting the department. Support the evaluation and lot disposition of intermediates and finished bulk drug substance through timely review of batch records, laboratory results and other GMP documents. Perform on the floor inspections of the production areas to resolve issues early and to ensure compliance with SOP and regulatory requirements. Perform preliminary risk assessment of deviation records and assign criticality levels, including, identification of root causes and establishment of corrective actions. Provide Quality Assurance Approval of deviations. Routinely provide compliance guidance to Manufacturing team. Serve as a QA-ATS representative for project teams. Use data to help drive quality improvement in documentation practices and production related activities. Assist in facilitating regulatory compliance inspections. Assist in product changeover, zone promotions, placing QA hold tags, logbook, extensions, PCS alarm review, Return to Service of areas and equipment, Paper based Master Batch Record review/approval, Electronic Batch Record review/approval including Parametrized and Parameter Values, and master data setup in the SAP. Maintain database and generate routine reports. Provide compliance guidance to the Manufacturing and Quality team.
REQUIREMENTS: Must possess a Master’s degree or foreign equivalent in Biotechnology, Pharmacy or a related field of study plus five (5) years of experience in the biotech/pharmaceutical industry in offered role or as a Quality Assurance Analyst, QA Auditor or a related position. Must possess five (5) years of experience in the biotech/pharmaceutical Quality Assurance sector with: FDA regulations including 21 CFR 210, 211, and 11; ICH guidelines; cleaning validation; equipment calibration and qualification; QA Lot disposition and release; QA compliance, audit, and inspection; validation and quality control; flow of material, personnel and equipment with production modules; gap analysis; risk assessment; deviation management system TrackWise (QMS); electronic document management system; recording, reporting, assessing, and reviewing alarm reports to control critical batch parameters for clinical, commercial, and validation runs; Biotechnology processes including fermentation, harvest, purification and formulation at commercial and clinical stage; SAP; lean tools including DMAIC, FMEA HERCA and six sigma certified yellow belt; and Quality Metric management using various databases and MS applications. In the alternative, the employer will accept a Bachelor’s degree or foreign equivalent in a stated field of study plus seven (7) years of progressively responsible experience in the biotech/pharmaceutical industry, (5) of which must have been as a Quality Assurance Validation Analyst, QA Auditor or a related position and seven (7) years experience in the above skill areas.
Click apply. No calls please. EOE.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.