Quality Assurance Compliance Specialist III
AstraZeneca

This is what you will do:

This role is responsible for ensuring quality and compliance of active GxP documentation and archived GxP records, as well as providing administrative support, technical and process-expertise, quality assurance, and general consulting as needed.

You will be responsible for:

Areas of responsibilities include, but are not limited to:

• Serving as the primary Point-Of-Contact for on-site GXP records archiving at the New Haven, CT site.
• Managing GXP Archives at the New Haven, CT site including receiving and logging archive requests, retrieving Records from internal customers, and coordinating with Records vendor/supplier to retrieve and archive records.
• Managing the Enterprise Archiving & Retention business-process and associated processes with direction from the Manager, Documentation Services.
• Managing Lab Notebook/Logbook processes in collaboration with the Analytical and BioAnalytical Sciences lab onsite.
• Performing verification of controlled documents within the Enterprise Content Management System (ECMS) for compliance to procedures.
• Providing excellent customer service support for service requests related to ECMS, Document Management processes, Audit and inspection requests, and collaborating with document owners/authors for any ECMS documentation related queries.
• Serving as a subject-matter-expert (SME) for Document Management, ECMS, Good Documentation Practices/ALCOA+, Data Integrity/Data Compliance, and other areas as assigned

You will need to have:

• 4 - 6 Years' Experience with Document Control (processing, verification, and archiving); Quality Assurance, Quality Systems, or related role in a GxP-regulated biopharma, medical device, or similar industry.
• Ability to work independently with minimum supervision.
• Experience in developing, implementing, and evaluating archives or records management. processes and systems. This includes cataloging, filing, and retrieving records, and creation and management of records retention schedules.
• Experience with GMP global regulatory requirements.
• Knowledge of archival metadata and metadata management.
• Ability to work in a fast-paced environment.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Preferred but not required experience:

• Bachelor's degree required (Science preferred, Business and other disciplines considered).
• Experience with electronic QMS applications including Veeva Vault Quality, TrackWise, ServiceNow, FirstDocs, Microsoft Office Applications, etc.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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 authorization and employment eligibility verification requirements.

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