Overview
Senior Specialist Development Quality Biologics Jobs in Waltham, Massachusetts, USA at AstraZeneca GmbH
To provide expert technical and analytical support to the Quality Control function including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology. The individual should be qualified to graduate level/or equivalent in a scientific field, with experience of working in a Good Manufacturing Practice laboratory environment.
The selected candidate will have strong knowledge and understanding of analytical chemistry and laboratory instrumentation, as well as Good Manufacturing Practice/Global Laboratory Practice. Must have an understanding of the Quality Control function, and its role and importance to the business.
Typical Accountabilities
:
Conduct activities and interactions consistent with what we value and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
Specific Responsibilities of Role Holder:
Ensures that systems and processes owned by the team are in a state of control and are effectively managed and maintained.
Prioritizes own workload effectively and efficiently, keeping in mind the needs of the partners and commitments of the team.
Represent the team as Subject Matter Expert (SME) in such topics as performance and understanding of biological assays, endotoxin, sterility, bioburden, mycoplasma, viral testing, aseptic processing, environmental monitoring, and utility sampling.
Train others on tasks, processes, and equipment in the labs.
Serve as lead investigator for Quality Events such as deviations, laboratory investigations, Environmental Monitoring Investigations, and Utility Investigations.
Ensure regulatory compliance of and appropriate availability of laboratory equipment to meet customer needs.
Serves as SME and Data Integrity champion for laboratory activities as appropriate.
Serve on global teams/forums as appropriate.
Act as a Lean champion, embracing Lean tools and principles and implementing continuous improvement initiatives.
Author and approve quality systems records (e.g., investigations, CAPAs, SOPs) and technical documents (e.g., trend reports, qualification and validation documents).
Essential Requirements:
Minimum of a Bachelor’s degree in a related subject.
Minimum of 2 years’ experience in a GMP QC Micro lab.
Demonstrated capability in aseptic sampling and testing.
High level of knowledge and competence with a specific piece of laboratory equipment, or a Quality process or system.
Desirable:
4+ years QC microbiology experience.
Experience in aseptic manufacturing and biologics.
Subject matter authority in Environmental Monitoring and Utility Monitoring.
Skilled in identifying and resolving contamination issues, including conducting investigations and implementing corrective actions.
Demonstrated project leadership capabilities.
Post-graduate degree such as master’s degree or PhD in a Science subject.
#J-18808-Ljbffr
Title: Senior Specialist Development Quality Biologics
Company: AstraZeneca GmbH
Location: Waltham, Massachusetts, USA
Category: Healthcare (Data Scientist, Medical Science), Quality Assurance – QA/QC
