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Title

Quality Assurance Specialist Sumner Seasonal) 

EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
 
About the Organization
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com .  
Description

QA Systems Specialist / QA Documentation/Lot Release Specialist I
QA Systems shift - 7:00- 6:00PM
The role will be joint between Quality Assurance Documentation (QAD) and Lot Release.

Position Overview:

Responsibilities and experience may include the following: Maintain document tracking system, issue and track document distribution and audit document manuals as required. Process Change Request, review documents for format and grammar and perform minor edits. Performs review of each document submitted for change/review to ensure compliance with existing procedures, identifies affected documentation and defines appropriate action. Issue controlled documents, i.e. batch records, forms, notebooks and protocol numbers. Maintain the GxP Document Archive and Records Retention Program. Support archive users by performing database searches, file retrieval and photocopying as needed. Scan completed documents.

The QA Documentation/Lot Release Specialist is responsible for supporting the QAD/ LR functions at the PA site. Responsibilities include the following:

Primary Activities - QA Documentation

• Maintain document tracking system, issue and track document distribution, and audit document manuals as required; including storage of hard copy documents in the on and off site archives.
• Process Change Requests: Review documents for format and grammar, compliance with existing documentation procedures, and perform minor edits.
• Issue controlled documents, i.e. batch records, forms, notebooks and protocol numbers.
• Maintain the GxP Document Archive and Records Retention Program.
• Support archive users by performing database searches and file retrieval and photocopying as needed.
• Scan completed documents such as notebooks, completed batch records and other documents as required.
• Maintain Point of Use manuals
• Regulatory Inspection support

Primary Activities - Lot Release Tasks
• Raw Material/Component Specification review
• Make copies of Batch Records for Lot Release Protocol compilation
• Compile data for Cumulative Impact assessments (CIAs)
• Compile data for Certificate of Conformance (CoC) e.g. Quality Control test results
Other duties as assigned

Education Requirements:
Associates or Bachelor's Degree

Special Skills/Abilities:
• Ability to read and comprehend simple instructions, short correspondence, and memos.
• Ability to write simple correspondence.
• Ability to effectively communicate information in one- on-one and small group situations to internal and external customers.
• Demonstrate strong time management and organizational skills related to customer support and time management.
• Ability to use electronic systems such as Microsoft Office, Excel and PowerPoint

Job Complexity:
Position requires the ability to solve problems within a team environment.

 
Position Requirements
  • Major in Engineering, Science or Pharmacology
  • Completed 2nd or 3rd year at the undergraduate level
  • Relevant courses include calculus and statistics
  • PC training includes Excel, PowerPoint, Word, and Access
  • Ability to be flexible with working hours
 
Full-Time/Part-Time Seasonal  
Location Philadelphia, PA  

This position is currently accepting applications.

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