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Research Associate II - Lab Operations/GxP Documentation

Location Gaithersburg, Maryland, United States Job ID R-072310 Date posted 02/13/2020

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 the Research Associate II, you will function as the point person for the procurement and management of laboratory reagents and supplies. Coordinate maintenance of non-computer-based equipment and prepare associated documentation in accordance with GxP; supporting operations of a regulated laboratory that performs PK and ADA bioanalyses in compliance with GLP / GCP guidelines.

Specific Responsibilities include:

  • Responsible for the ordering and stocking of laboratory reagents and supplies to meet development, validation and sample testing needs of regulated bioanalytical lab (HBS and GXP compliance).
  • Coordinates across departments, vendors and systems to schedule preventative maintenance, calibration and validation activities of laboratory non-computer-based equipment to ensure GLP compliance. Prepares associated documentation in accordance with GXP.
  • Maintains and updates GXP lists of equipment supporting regulated bioanalytical studies to include calibration and maintenance dates.
  • Manages the receipt and storage of laboratory reagents and supplies and may supervise others on these tasks.
  • Functions as the point of contact for the transfer of reagents to and from CTL_GB within AstraZeneca as well as to external contacts.
  • Manages the Reagent Inventory Module of the Clinical Testing Laboratory Information Management System (CTLIMS). Trains others on the use of this module.
  • Responsible for receipt and review of daily temperature chamber unit temperature recordings and follow up of excursions as per SOPs 
  • Maintains and updates electronic inventories of reagents.
  • Updates reagent freezer maps monthly
  • Responsible for coordination and receipt of CTL_GB wash buffer as per SOP
  • Responsible for coordination of quarterly pipet calibrations and out-of-tolerance follow ups
  • Assists with preparation and review of Standard Operating Procedures (SOPs)
  • Experienced in operational requirements of bioanalytical laboratory measuring PK and ADA in nonclinical and clinical samples.
  • Proposes changes or modifications of systems and procedures to improve operational efficiency.
  • Participates and presents at departmental meetings.
  • Prepares reports and updates for management.
  • Attends required training sessions.
  • Applies knowledge of good laboratory practices on a daily basis
  • Knowledgeable of shipping requirements and proper handling and disposal of biohazardous materials

Education Required:

BA, BS in Biological science or Chemistry with a minimum of 2-5 years’ experience in an FDA regulated or medical environment, or MS with 0-2 years of related work experience in an FDA regulated or medical environment.

Experience Required

Working knowledge of GxP documentation requirements and practices. Must have excellent PC skills, utilizing Microsoft Office products Word, Excel and LIMS.  Experienced in ordering supplies and coordinating across internal and external groups to support laboratory operations.  Demonstrated high level of commitment to quality in work. Requires ability to organize and prioritize tasks in a timely and accurate manner.

Special Skills/Abilities

  • Excellent interpersonal organization skills
  • Good verbal and written communication skills
  • Skilled in managing and enhancing capabilities of databases for complex inventories
  • Exceptional communication and negotiation skills

Preferred Skills:

Experience with the following systems preferred:

  • ProCal
  • TrackWise
  • CT-LIMS Labware
  • IBuy
  • Assay Depot/ The Scientist

Next Steps – Apply!

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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