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QA Specialist II/III (12 hour weekend night shift) - Operations

Местоположение Фредерик, Мэриленд, США Идентификатор вакансии R-097443 Дата публикации 01/12/2021

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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 outstanding skills with those of people from all over the globe.

Our Frederick, MD facility creates life-changing medicines for people around the world! We make a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements.

The Frederick Manufacturing Center is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives. We are also an award-winning employer and has been recognized as a ‘Top 50’ Business in Frederick, and Frederick County’s ‘Best Place to Work’ distinction in 2015 and 2019.

This position will be a QA Specialist II or III based on experience.

**This role is weekend, 12-hour night shift—Saturday, Sunday, Monday (6pm-6:30am)**

Main Responsibilities:

  • 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 labeling, 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.

Minimum Requirements:

Quality Assurance Specialist II

  • Bachelor's degree; biology, engineering or science-related field preferred
  • 2+ years of industry experience
  • QA experience preferred

Quality Assurance Specialist III

  • Bachelor's degree; biology, engineering or science-related field preferred
  • 5 years of total industry experience
  • 3+ years of QA experience preferred

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 embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Отличная корпоративная культура, отличные рабочие условия, поддерживающий менеджмент. Возможность ротации внутри компании. Они ценят инклюзивность и разнообразие.