Laboratory Coordinator - documentation, compliance in Branchburg, NJ at Apex Life Sciences

Date Posted: 11/12/2018

Job Snapshot

Job Description


Responsibilities: 

  • Organizes, conducts, and monitors laboratory compliance activity.
  • Responsible for CTU alarm response and resolution and ensuring compliant laboratory practices.
  • Participates in routine lab maintenance, lab safety, ISO and QSR implementation.
  • Has primary responsibility for training new or temporary departmental employees.
  • Reports employees progress to supervisor and document training process as per internal procedures.
  • Serves as primary contact person for scientific staff concerning laboratory compliance, logbooks, and acquisitions.
  • Contacts appropriate Facilities staff or outside service contractors to schedule repair and preventative maintenance as may be required by position.
  • Reports malfunctions to supervisor and makes sound recommendations to solve problems.
  • Establishes as appropriate internal/cross-functional/customer relationships.
  • Monitors lab supply inventory, generates expense purchase requisitions, inputs production data and other work-output data into appropriate network (e.g. SAP, RAM, etc.) or departmental database, and maintains documentation in accordance with established procedures.
  • Provides input for improving existing laboratory procedures and makes sound recommendations to solve problems.
  • Assists supervisor in development and implementation of new procedures and evaluating new laboratories.
  • Writes or assists with generation of written standard operating procedures.
  • Team member for projects and continuous improvement activities.
  • Assist in the areas of equipment compliance and calibration.
  • Aids in equipment non-conformance investigations
  • Schedules all calibration and preventative maintenance events for all vendor equipment
  • Tracks expenses and contracts


Qualifications:

  • Bachelor's degree in a Scientific or related field desired
  • Experience conducting and writing nonconformance investigations and experience with equipment and laboratory compliance in a GMP environment is highly desirable. Laboratory Experience not required.
  • Basic GMP knowledge a plus.
  • Must be motived, flexible, focused and use independent judgment to make decisions in a high paced work environment.
  • Demonstrates competence in reading and completing charts, forms, and other documents.
  • Proven ability to use personal computer, word-processing and spreadsheet applications.
  • Good written and verbal communication skills a must.
  • There is an on-call requirement one week per month, worker will be on call and must answer any/all calls that come through during that time

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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