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Job ID : 36466

Location : Texas City, TX

Company Name : Atechstar

Job Type : Full-Time, Part-Time, Contract, Training

Industry : Information Technology

Salary : $33000 - $42000  per year

No. of Positions : I have ongoing need to fill this role

Required Skills : Introduction, Strong Analytical Skills, Technical Proficiency..

Benefits : Medical Insurance, Dental Insurance, Vision Insurance, 401K, Life Insurance

Job Description :
  • Responsiblties:
  • Confirming and ensuring the compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
  • Monitoring and ensuring of current Good Laboratory Practices followed by laboratory personnel during routine operation to ensure adherence to procedure.
  • Verifying process validation and characterization-related documents.
  • Coordinating with the Regulatory Affairs and Analytical Laboratory Teams to arrange required documents for timely submission as part of new and existing abbreviated new drug applications.
  • Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents.
  • Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor for necessary improvements in the identified areas.
  • Actively participating in laboratory investigations and incidents as well as ensuring the proper compliance.
  • Evaluating and confirming the compliance related to raw materials, inprocess and finished product analytical documents.
  • Conducting random internal audits in analytical lab and ensuring the compliance.

Key Skills:

  • Introduction.
  • Strong Analytical Skills.
  • Technical Proficiency.
  • Excellent Communication Skills.
  • Problem-Solving Abilities.
  • Knowledge of Testing Techniques.
  • Adaptability and Continuous Learning.

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All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. is not a Consulting Company/Training Company/H1B Sponsor.

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