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Lieu: Frederick, Maryland, États-Unis
ID de l'offre 12690737
Date de publication: 08/15/2019

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.

***This position is posted as a II/III/Lead role based on experience.***

As the Associate II/III/Lead – Technical Operations you will perform quality- and compliance-related tasks for the Facilities and Engineering Department in support of a Multi-Product Large-Scale Biologics Manufacturing Facility, which operates 24/7.


Main Responsibilities:

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and/or tasks, etc. associated with this job title as it relates to the applicable knowledge and experience levels:

Major areas of responsibility may include the following:

  • Audit support preparation and lead/point person for F&E (external inspections)
  • Host for internal inspections
  • Quality records tracking (overdue and coming due reports)
  • Monthly F&E metrics reporting
  • Periodic review tracking for logbooks and SOPs (overdue and coming due)
  • Providing consistency/standard for writing quality records (deviations, change controls, action items, UIR/EMIR, CAPAs, E-Checks, evaluation records) in coordination with SMEs
  • Attending meetings as required
  • Supporting projects as needed
  • Instrument OPTs reporting/tracking
  • Trending of quality records (deviations, OPTs)
  • Risk register reporting/tracking
  • Maintenance/calibration paperwork archival
  • Additional job functions:
  • Detail oriented and be able to complete any required (GxP) documentation
  • Candidate must be proficient in Microsoft Excel
  • Experience with TrackWise preferred
  • Must have ability to communicate both orally and written in a clear manner
  • Ability to work in fast-paced environment
  • Good organizational skills

Minimum Requirements:

  • BS/BA degree
  • 3 to 5 Years of experience

Associate II:

  • Full knowledge of the job.  Substantial acquaintance with and understanding of general aspects of the job with a broad understanding of the detailed aspects of the job.
  • Ability to apply common sense understanding to carry out simple one- or two-step instructions.  Ability to deal with standardized situations with only occasional or no variables.
  • General supervision and instructions given for routine work and detailed instructions given for new activities or special assignments.
  • Errors can be detected and corrected but may cause moderate loss of time or customer/user dissatisfaction.
  • Contacts are typically with individuals within own department and occasionally with contacts outside own organization.  Contacts involve obtaining or providing information or data requiring some explanation or interpretation.

Associate III:

  • Considerable knowledge of the job.  Complete acquaintance with and understanding of the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered.
  • Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.  
  • Ability to deal with problems involving a few concrete variables in standardized situations.
  • Limited supervision.  No instructions needed on routine work, and general instructions given on new lines of work or special assignments
  • Errors may be difficult to detect and would normally result in loss of customer business, material, or equipment to resolve.
  • Contacts are frequent with individuals representing other departments, and/or representing outside organizations.  Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation.

Lead:

  • Extensive knowledge in specialized functions.  A wide and comprehensive acquaintance with, and understanding of, both general and specific aspects of the job and their practical application to complex problems and situations ordinarily encountered.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.  Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to solve practical problems and deal with a variety of variables in situations where only limited information exists.
  • Capable of training and leading other less experienced staff.
  • Minimal supervision.  Work may be done without established procedures. 
  • Errors are very difficult to detect and would normally require significant expenditures to resolve.
  • Contacts are frequent with individuals representing outside organizations and/or individuals of significant importance within the company.  Contacts involve planning and preparation of the communications, require skill, tact, persuasion and/or negotiation to accomplish the objectives of the communication.

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.

Associate II/III/Lead – Technical Operations
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