• United States Of America, Usa

Job Description:

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 Were 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, youll 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 PERCENT of our global workforce With 30 production facilities in 18 countries were 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 thats 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//lnkdin/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


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 AstraZenecas interest in pharmaceuticals professional associations, discussions groups, etc
Strong performance history of consistently meeting and exceeding expectations

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 18th Mar 2020

Key Skills:

Company Profile:


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