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Lieu: Philadelphie, Pennsylvanie, États-Unis
ID de l'offre 13370119
Date de publication: 09/17/2019

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 Technical Specialist, 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

As the Quality Control Technical Specialist, you provide routine support for the Quality Control Laboratory and ensure cGMP quality systems/processes are maintained while developing as a subject matter expert (SME) in one or more defined areas.

This position provides a wide range of possible opportunities to support QC operations, such as:

  • Analyst mentoring
  • Quality Control (QC) project lead
  • Assisting QC management during regulatory audits
  • Authoring/reviewing QC Standard Operating Procedures (SOPs)
  • Authoring and/or conducting laboratory investigations
  • Performing and/or leading Technology Transfers
  • Authoring and/or performing instrument qualifications
  • Performing and/or supporting Annual Product Quality Reviews
  • Bench analyses

Major Responsibilities:

  • Ensures appropriate cGMP Quality Systems are in place through review and approval of documentation and delivers support in defined areas of expertise. This could include but is not limited to interfacing with QC and site departments to ensure systems, processes, facilities, utilities, equipment, and instruments are in accordance with current Good Manufacturing Practices.
  • Trains and mentors analysts of various levels on appropriate testing technique associated with laboratory analyses.
  • Reviews laboratory analyses and executed protocols for accuracy and completeness.
  • Leads one or more multi member projects related to Quality Control continuous improvement objectives.
  • Provides Quality support and technical expertise to cross-functional groups and personnel on projects, as appropriate.
  • Supports site regulatory inspections; interfaces with Regulatory Agencies during inspections. Participates in the
  • preparation of document packages and responses to regulatory agencies.
  • Supports the preparation of the site Annual Product Quality Review (APQR) reports in alignment with the Regulatory
  • Annual Report schedule, Q&CM Policies and Procedures, and site SOPs within Quality Control.
  • Communicates and builds cooperative relationships with third-party colleagues and within AZ.
  • Authors, reviews, and approves documents including standard operating procedures (SOPs), protocols, deviations,
  • CAPAs, reports, and other GMP documents as required.
  • Submit, review and route department change controls as necessary. Coordinates the review and approval for qualification reports related to laboratory equipment and other laboratory facilities qualifications (i.e. hoods, glassware washers etc.)
  • Provide scheduling support for laboratory activities as needed.
  • Supports and delivers on Technology Transfer activities as related to Quality Control.
  • Tracks and reports key laboratory metrics as assigned.
  • Serves as backup administrator to QC systems such as LIMS, MODA and QC Instruments
  • This is a day shift position. Evening or weekend work may be required to ensure adequate support of production and/or quality related processes.
  • Minimum travel is required. Less than 10% travel when necessary to benchmark other sites, attend meetings and/or technical conferences is possible.


Qualifications:

Education:

  • Bachelor’s degree: ideally in Microbiology, Biological Sciences or related discipline. Equivalent relevant work experience may substitute for education.

Required:

  • Solid understanding and knowledge of cGMP and regulatory principles in a pharmaceutical manufacturing environment.
  • Excellent interpersonal, verbal, and written communication skills with the ability to communicate with all levels of the organization.
  • Proven analytical skills and ability to transfer findings into report and presentation formats.
  • Ability to work in an action-oriented, fast-paced, and rapidly changing work environment.
  • Ability to prioritize workload and manage multiple and varied tasks with enthusiasm.
  • Experience with Microsoft Office applications (i.e. Excel, Word, PowerPoint).
  • Experience in retrieving, assessing, and reporting analytical data and trends.
  • Ability to work independently as well as to effectively collaborate with a team.
  • Experience participating in and responding to inspections by internal and external auditors.
  • Experienced analytical/cGMP data reviewer.

Preferred:

  • Minimum of five (5) years Quality Control laboratory experiencein biopharma, medical device, or pharmaceutical manufacturing
  • High level of knowledge and competence with a specific piece of laboratory equipment, or a QC/QA process or system.

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 Control Technical Specialist, Philadelphia, PA - Global Operations
Qualité

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