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Lieu: Frederick, Maryland, États-Unis
ID de l'offre 12377083
Date de publication: 06/26/2019

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 a Quality Assurance Supervisor 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.

Note: This role is for a Second/Night Shift-Tuesday to Friday-10 hrs. shift.

Hours: 1:30pm-12am.

Main Responsibilities

Scope:

  • Performs selected quality assurance activities, dependent upon assigned area, including the following:
  • Supervises direct reports to ensure completion of area functions
  • 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
  • Supervises direct reports to ensure completion of area functions
  • Manages shift resources and schedule adherence
  • Utilizes tier structure to review/communicate metrics and cascade critical information.
  • Supports lean culture by driving waste reduction and problem-solving behaviors
  • Mentors and develops staff
  • Works cross-functionally to resolve issues and achieve site/company goals
  • Technical expertise of functional area requirements.
  • Application of corporate policies and industry regulations to drive standardization. 
  • Cross-functional knowledge of other business processes and procedures to ensure smooth execution of site strategies.
  • Uses a variety of tools to analyze data to develop solution options.
  • Develops solutions for complex problems that may impact multiple functional areas.
  • Solutions are creative, thorough, and advance the organizational objectives.
  • Independently manages day to day workload and establishes own priorities.
  • Establishes and manages team assignments with autonomy.
  • Receives strategic guidance but is free to develop implementation plans
  • Contributes to department goals by leveraging work of others.
  • Provides training and mentoring 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.
  • Develops tactical actions to achieve strategic goals.
  • Frequent inter-organizational and external contact at multiple levels.  
  • Represents the organization on cross-functional and external teams
  • Provides supervision to direct reports. 
  • Coaches and mentor staff to ensure team expertise and adequate succession planning.
  • Conduct activities and interactions consistent with Company values 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.
  • Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
  • Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness. 

Education:

  • Bachelor's degree required. Biology, Engineering or Science-related field preferred

Experience:

  • 7 years industry experience 
  • 4 years of experience in QA and supervisory/lead experience preferred

Important: This role is for a Second/Night Shift-Tuesday to Friday-10 hrs. shift.

Hours: 1:30pm-12am.

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

Quality Assurance Supervisor - Operations
Qualité

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