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Quality Assurance Specialist IV at AstraZeneca in Frederick, Maryland

Posted in Other 30+ days ago.

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.

Brief Job Description

The Quality Assurance Specialist performs selected quality assurance activities.

Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)

This position is 12 hour Weekend Nights,6pm to 6:30am) for three nights (Saturday, Sunday and Monday).

Performs selected quality assurance activities, dependent upon assigned area, including the following:
* Reads, understands, and follows SOP's and complies with cGMP's
* Writes new standard operating procedures or revises existing documentation utilizing document management systems
* Supports the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents
* Supports the issuance and reconciliation of GMP documentation
* Electronic system usage with tools such as Trackwise, GQCLIMS, Pas-X and SAP

Performs broad spectrum of routine tasks in their functional area
* Reviews documented information from their functional area, reports abnormalities
* Assists in the implementation of new processes.
* Assists supervisor by assembling metrics as requested for their functional area.
* Provides task-oriented training to Specialists.
* Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items.
* Represents QA on site committees such as SHE, etc.
* Proposes and implements process and other efficiencies as approved by supervisor.

Identifies process improvements in their functional area
* Coordinates implementation of new processes in their functional area.
* Prioritizes day-to-day support for their functional area and longer term projects or investigations
* Integrates knowledge and experience as skilled specialist with knowledge of corporate and industry standards with respect to their functional area.
* Creates/revises QA documents (SOPs, technical reports, risk assessments) in document management system
* Creates and manages deviations, change controls, and CAPA records pertaining to their functional areas in QIMS
* Supports internal audits of manufacturing, analytical testing, labelling to ensure compliance with SOPs and regulatory requirements per the requirements of the self-inspection program
* Facilitates and coordinates training of new and existing team members, prepares training materials as necessary.
* Represents QA, as needed, during meetings relevant to their functional area, communicates, tracks all follow-up items through to completion
* Provides guidance to lower-level associates on a daily basis
* Serves as subject matter expert for area core functions
* Provides support for both internal and external inspections
* Approves reports, investigations and other Quality System records on behalf of QA, as needed
* Organizes and leads periodic review of existing QA processes
* Performs risk assessments for variety of processes
* Provides day to day direction and training of lower-level associates and mentors QA specialists, as needed

Technical understanding of biotechnology processes.
Application of corporate and industry regulations and standards to job function.
Subject matter expert of functional procedures and activities within core area.
Applies knowledge to complex assignments that are non-routine and variable.

Analyze data to develop solution options.
Develops solutions for problems of increasing scope and complexity.
Solutions are creative, thorough, and consistent with organizational objectives

Works under increasing autonomy.
Independently manages day to day workload and establishes own priorities.
Acts as team lead and can delegate work to others
Work is reviewed upon completion for adequacy in meeting objectives.

Contributes to department goals through quality and efficiency of assignments/projects.
Provides training and coaching to ensure adequacy of others' work.
Enhances lean culture through complex problem solving and identification/implementation of improvement opportunities.
Provides customer service to internal and external clients.

Frequent inter-organizational contact at multiple levels.
External contacts related to organizational goals.
Represents the organization on cross-functional and external teams.

No direct reports but may provide training, coaching and delegate job assignments as needed

Education, Qualifications, Skills and Experience

  • BS degree required with 7 years of biopharmaceutical/pharmaceutical with minimum 5 years of experience in Quality Assurance, or MS degree holder - Minimum 3 year experience of biotech/pharmaceutical Quality Assurance experience.
  • Operational Excellence/LEAN experience.
  • Manufacturing Quality (on the floor) experience.
  • Problem-solving experience

Key Relationships to reach solutions
Internal (to AZ or team)
* Director - QA

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.