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Quality Control - Chemist - Newark, DE - Global Operations

Lieu Newark, Delaware, États-Unis Job ID R-061315 Date de publication 09/16/2019

At AstraZeneca we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Quality Control Chemist/Sr. Chemist in Newark, DE, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

The core purpose of the Chemist roles in QC is to coordinate and execute the flow of QC testing activities within the Laboratory.  This includes the following key activities; sample receipt, preparation and execution of QC testing, review and approval of data.  In addition to this, Chemists also get involved in scheduling and workload planning, monitoring for trends and abnormalities, project work, and laboratory investigations.

The successful candidate will be hired at wither the "Chemist, Sr. Chemist" or "Principal Chemist" level depending on education and experience.

Major Responsibilities:

  • Performs routine and non-routine laboratory testing.
  • Performs or leads project work, including tech transfers, method and equipment/software validations.
  • Authors, reviews, or approves supporting documentation relevant to the laboratory (ie… SOPs, training documents, CAPAs, OOS and deviation investigations, change controls, etc).
  • Serves as a SME and technical leader in the laboratory, laboratory equipment, processes, software, or systems, troubleshooting roadblocks, and training other employees as needed.
  • Serves on global teams and forums, functioning as a SME for global systems as appropriate.
  • Enter, process, and review data in various software programs (ie… LIMS, Empower, SAP, etc).
  • Reviews and approves QC data, while monitoring for trends and abnormalities. Reports, and acts on data results.
  • Serves as the main point of contact for testing, contract services, and special testing requests including PET investigations and validations.
  • Performs general maintenance/preventative maintenance/calibration activities when appropriate.
  • Serves as a SME for the raw material program, including sampling and testing, review and release.
  • Demonstrates excellent interpersonal communication with personnel inside and outside of QC.
  • Represents the QC lab during audits and regulatory inspections.
  • Performs tasks typically assigned to the Senior QC Technician role as needed.

Career Level Descriptions
The Job Responsibilities provided above represent the full scope of the role. The descriptions below indicate the performance expectations at different career levels.


Chemist

At this level, the incumbent is not necessarily performing all the major responsibilities of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.

Senior Chemist

At this level, the incumbent will be trained and able to demonstrate a foundational level of understanding of all the major responsibilities of the role. The incumbent will also demonstrate a high level of proficiency in the primary processes the individual manages.

In addition to this the incumbent must have consistently demonstrated the following:

  • Serves as the main contact for issues as they arise, and aid/direct troubleshooting activities when appropriate.
  • Acts as a leader in the laboratory through display of leadership capabilities.
  • Aids in the development of chemists/senior chemists through mentoring and training.
  • Self-motivated, demonstrates leadership, and works independently with minimal guidance from management.
  • High level of proficiency in problem-solving, creativity, independent thought, and sound judgment.
  • Influence in team and project meetings, advising project teams with respect to technical solutions and potential new approaches for consideration.
  • Oversight of activities of employees, contractors, and interns.
  • Strong performance history of consistently meeting and exceeding expectations.


Principal Chemist

At this level, the incumbent will have cross-trained and demonstrated strong knowledge and expertise in all the major responsibilities and processes of the role. The incumbent will also demonstrate an expert level of proficiency in the primary processes the individual owns or is aligned with. The incumbent will act as execution lead/process

owner for one or more processes.

In addition to this the incumbent must have consistently demonstrated the following:

  • A passionate champion of laboratory quality and compliance; maintaining current knowledge of technical and industry trends and actively communicating these to colleagues.
  • Leading/driving step-change improvements to methods and processes through cross-functional project teams.
  • Expert level understanding of cGMPs, Analytical Test Methods, and competency to provide back-up coverage for the QC Senior Manager as needed.
  • Influencing and negotiating at all levels of the organization: globally and inside and outside of QC to deliver significant improvements in laboratory operations.
  • Developing others by coaching/mentoring less experienced employees and interns.
  • Supervision and oversight of activities of employees, contractors, and interns.
  • Represent AstraZeneca’s interest in pharmaceuticals professional associations, discussions groups, etc.
  • Strong performance history of consistently meeting and exceeding expectations

Qualifications:

Education:

  • Bachelor’s degree in a Science subject (Chemistry, or closely related subjects).

Chemist:

Required:

  • Prior experience and demonstrated capability through the QC Senior Technician role.

Desired:

  • Minimum of two (2) years of chemistry laboratory experience.
  • High level of knowledge and competence with a specific piece of laboratory equipment, or a QC/QA process or system.
  • GMP experience.

Senior Chemist:

Required:

  • Minimum of three (3) years' laboratory experience.

Desired:

  • Minimum of five (5) years of QC chemistry laboratory experience.
  • Minimum of two (2) years GMP experience.
  • Project management experience.
  • Higher level degree.

Principal Chemist:

Required:

  • Masters or PhD degree in a Science subject (Chemistry, or closely related subjects).
  • Minimum of five (5) years' laboratory experience.

Desired:

  • Minimum of seven (7) years QC chemistry laboratory experience.
  • Minimum of three (3) years GMP experience.
  • Project management experience.
  • Demonstrated leadership competency.

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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