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Sample Coordinator-QC-Operations

地点 弗雷德里克, 马里兰州, 美国 职位 ID R-072552 发布日期 01/27/2020

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost 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 exceptional skills with those of people from all over the globe. As a Sample Coordinator - Day Shift in Frederick, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

This is a day shift role.

Main Responsibilities

Scope:

Responsible for performing laboratory support functions, including Technician functions, and others, which may include:

  • Parts and glassware washing and autoclaving, including proper documentation of these activities
  • Schedules and maintains laboratory equipment according to standard operating procedures
  • Ensure proper handling and chain of custody for all samples in Quality Control, from entry though final disposal
  • Sample reconciliation on daily basis
  • Aliquot samples and distribute for testing to the labs
  • Defrosts and maintains laboratory equipment according to standard operating procedures.
  • Enters data evaluated for compliance to specifications and reports abnormalities.
  • Reads, understands, and follows SOP’s and complies with cGMP’s
  • Responsible for writing new standard operating procedures or revising existing documentation.
  • Applies critical thought to solving problems.
  • Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis.
  • Follows all safety regulations as required by AstraZeneca Policies and Procedures.
  • Sample login in to Laboratory information systems such as GQCLIMS and MODA
  • Sample disposal
  • Receive incoming shipments, log samples and distributes samples to the QC labs
  • Sample transport between buildings
  • Schedule and prepare outgoing shipments for Warehouse
  • Performs assigned tasks per the schedule
  • Maintains training >95% completed on time, with 100% completed prior performing any related tasks
  • Owns minor deviation records
  • Owns simple VSCR and CAPA records
  • Performs review of logbooks within the department
  • Perform stability pulls and staging
  • Assists in execution of protocols and stability studies
  • Manage inventory of the reference standards

Complete knowledge of the job.  Full understanding of the general and detailed aspects of the job.  Familiarity with standards and guidance, internally and externally to the company, with which the department must conform.

Provides solutions to a variety of technical/business problems of moderate scope and complexity.

Works under limited supervision.  Follows established procedures to perform job requirements.  No instructions needed on a routine basis. General instructions required to perform new activities or special assignments.  Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.

Errors can be detected and corrected but may cause moderate loss of time or customer/user dissatisfaction.

Frequent contacts with equivalent level contributors and customer representatives concerning projects, operational decisions, scheduling requirements, or contractual clarifications.  Conducts briefings and technical meetings for internal and external representatives.

Accomplishes tasks mainly as an individual contributor, but also with some indirect supervision of non-exempt employees such as QC Technicians – providing work prioritization and occasional scheduling of their activities.

Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.  Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.   Report potential issues of non-compliance.

Education:

  • HS diploma or AA degree in relevant area is required.
  • Bachelor’s degree is a plus.

Experience:

  • 0-5 years of experience in QC required.
  • 3+ years of relevant QC experience in Scientific / Biotech / Pharmaceutical field with HS diploma is preferred.

This is a day shift role.

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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