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Clinical Operations
Category: Manufacturing
  • We need you for Contract
  • This job pays $17.46 - $20.54 per hour per
  • **job details: **
    + reference: 25318

Job code: lhw-e0-90661743

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  Job posted:   Thu Jun 7, 2018
  Distance to work:   ? miles
  2 Views, 0 Applications  
Clinical Operations
Clinical Operations

job description**

Clinical Operations

**Job Title:** Bioanalyst I

**Job** **Responsibilities**

+ Provides administrative duties for quality laboratory computer systems; ensures efficient trouble-free operation of systems; trains and provides support for end users; installs associated equipment (barcode readers, printers, etc.); documents and troubleshoots system issues.

+ Revises quality system SOP's related to lab systems.

+ Assures that all data and information is gathered and recorded in accordance with cGMP requirements.

+ Supports the configuration and implementation of new standalone and networked quality laboratory computer systems.

+ Responds to inquiries from management and employees and communicates status on a frequent basis.

+ Assists in planning, directing, and documenting user acceptance testing.

+ Maintains close communication with stakeholders and team members to keep subject parties apprised of relevant issues.

+ Verifies that backup, archival, and retrieval of electronic cGMP data is performed successfully.

+ Ensures project deadlines and performance standards are met, and communicates status accordingly.

**Education &** **Qualifications**

+ Bachelor's degree in Biology or related subject with 2-3 years experience in the FDA regulated industry

+ Ability to effectively collaborate with others to achieve team goals and expectations.

+ Must be familiar with cGMP.

+ Must be able to work independently and in a team environment.

+ Prior experience with Environmental Monitoring and/or Finished Product testing for microbiology.

+ Prior trending experience preferred.

+ Prior experience with implementing or validating LIMS preferred.


+ Medical, Dental, and Vision Insurance

+ 401K Plan with Company Match

+ Life and AD&D Insurance

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