Quality Control Senior Analyst - QCIS - Operations Astrazeneca
Frederick, MD

Job Description

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As Quality Senior Analyst-QCIS in Frederick, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Main Responsibilities

Scope:

* Perform day-to-day activities of Quality Control computerized systems, such as LIMS, OpenLab, Empower, and lab computer systems
* Perform application administration tasks for QC computerized systems
* Liaison between QC and the Validation group with relation to software/computer system validation
* Liaison between QC and IT to administrate all software/computer applications and fulfill all networking and security requirements
* Liaison between QC and Operation IS in maintaining LIMS, OpenLab, and other enterprise systems
* Facilitate and coordinate training of new and existing LIMS users, prepare training materials as necessary
* Creates and manages deviations, change controls, and CAPAs related to QC computerized systems.
* Work with Operation IS to implement changes to corporate systems such as LIMS, OpenLab, etc.
* Create/Maintain SOPs related to QC information systems
* Manage QC system interface with other MedImmune/AstraZeneca enterprise systems such as SAP
* Support QC information system lifecycle management activities from concept, development, validation, implementation, maintenance, to retirement

Knowledge:

* Complete understanding and wide application of technical principles, theories, and concepts in the field. General knowledge of other related disciplines.

Problem Solving:

* Provides solutions to a variety of technical problems of moderate scope and complexity.

Freedom To Act:

* Works under limited supervision. Follows established procedures to perform job requirements. No instructions needed on a routine basis. General instructions required to perform new activities or special assignments. Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.

Impact:

* Errors may not be readily detected, but can be corrected; may delay lot release, projects and milestones.

Interpersonal Communication:

* Frequent inter-organizational and outside customer contacts.
* Represents the organization in providing solutions to difficult technical issues associated with specific projects.

Education:

* Bachelors required: Science/ Scientific / Biotech / Pharmaceutical / IT field of study.

Experience:

* Preferred 4+ years information management experience/QC Analyst background.

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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