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Quality Control Microbiology Supervisor (2nd Shift) - Operations

Местоположение Фредерик, Мэриленд, США Идентификатор вакансии R-103565 Дата публикации 03/24/2021

At AstraZeneca, we continuously forge partnerships that help pursue extraordinary medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe. Working here means being results-oriented, thinking big and working together to make the impossible a reality. We’re passionate about the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can really change the course of medicine and bring big new insights to life. With 30 production facilities in 18 countries we’re passionate about supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Come and thrive in our vibrant, energizing, connected and encouraging culture and make a real difference to patients.

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world. This biologics manufacturing facility makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. It’s challenging but highly rewarding work, involves more than 675 hardworking people throughout the manufacturing lifecycle and supporting office functions. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. 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 committed to continuous learning and offer ongoing skill building and training for our staff and encourage additional secondary schooling with tuition reimbursement of 100% up to $10,000 each year. The FMC is also an award-winning employer and has been recognized as a ‘Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’ distinction in 2015 and 2019. Come join our award-wining team and support the manufacture of life-changing medicines for patients across the world.

Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

**This role is 2nd Shift, M-F (4pm-12:30am)**

Main Responsibilities:

  • Schedules sampling and assays, personnel and equipment to ensure timely completion of routine testing and special projects.
  • Reviews data generated in the laboratory prior to release of information.
  • Oversees equipment maintenance ensuring routine PM or calibrations are completed.
  • When required, performs deviation investigations and/or Out-of–Specification investigations.
  • Oversees implementation and maintenance of Quality Control Systems, and ensures cGMP compliance.
  • Represents QC at internal, partner and external regulatory audits during laboratory tours and QC process discussions/requests
  • Generates Standard Operating Procedures and protocols.
  • Oversees validation of test methods to support release of materials.
  • Assists in validation of new equipment.  Recognizes, troubleshoots, and resolves moderately complex problems with equipment or individual assays.
  • Responsible for on-time delivery or closure of QC owned deliverables (TrackWise records, testing plans, specifications, biennial reviews of procedures, PQR sections, regulatory submissions, KPIs, etc) with help of other management and technical specialists as needed.
  • Supervises Analysts, Sr. Analysts and Specialists, to include communications, development, compensation and performance reviews, goal setting, training, and other using AZ management tools and policies.
  • Assures trending is performed as required for analytical results, OOS, analyst performance, etc.
  • Identifies and delivers lean and efficiency projects for QC processes.
  • Assists with developing yearly budget for instruments and support contracts, as well as lab supplies, etc for area of responsibility.
  • Maintains area of responsibility within budget
  • Assignments are received in task and objective oriented terms.  Day to day oversight of org unit carried out without appreciable direction.  Provides direction to subordinates based on general policies and management guidance.  Work is reviewed for adquacy in meeting objectives.  Interprets and executes policies and procedures that typically affect subordinate organizational units.  Recommends modifications to operating policies.
  • Ability to solve routine supervisory problems related to oversight of the org unit.

Minimum Requirements:

  • Bachelor’s degree or 4 additional years of work experience in lieu of degree
  • 6 + years analytical testing experience in pharmaceutical or biopharmaceutical industry

Preferred

  • Master’s degree 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 phenomenal 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.