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Frederick, Maryland, United States
Job reference: R-051306
Posted date: May. 21, 2019

AstraZeneca Pharmaceuticals LP

QA Specialist IV position available in Frederick, MD to 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, Trackwise and SAP.  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, Master Batch Record, PVL, Electronic Batch Record review, and master data setup in SAP.  Maintain database and generate routine reports.  Provide compliance guidance to the Manufacturing and Quality team.  Position requires a Master’s degree or foreign equivalent in Pharmaceutical Systems Management, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field plus five (5) years of progressively responsible experience in the job offered, Quality Assurance Validation Analyst, Associate QA Auditor, QC Analyst II, QA Associate, or a related position.  Must have 5 years of progressively responsible experience in the biopharmaceutical or pharmaceutical industry with:  FDA regulations including 21 CFR 210, 211, and 11; ICH guidelines; data integrity; 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; electronic document management system; recording, reporting, assessing, and reviewing critical alarm reports for clinical, commercial, and validation runs; SAP; 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 plus seven (7) years of experience.  The employer will accept pre- or post-Master’s degree experience.  Any suitable combination of education, training, or experience is acceptable.  6pm to 6am /12 hrs shift [2 dys on – 2 dys off /3 dys on – 3 dys off].  EOE.

To apply, click “Apply” below and follow instructions to submit resume.  No calls please.

QA Specialist IV

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