Quality Specialist 1

  • Company:
  • Location:
  • Salary:
    negotiable / month
  • Job type:
  • Posted:
    4 weeks ago
  • Category:
    Healthcare | Biotechnology/Pharmaceutical/Medicine

Skill: information technology , database management , written communication; Exp: 0-3 years; Description PURPOSE Act as a specialist and point of contact for the local laboratory teams to gather requirements for testcodes and provide guidance on testcode requests. Support study teams as necessary on technical questions related to testcode structure, analytical attributes and functionalities. Collaborating with Global Lab Harmonization, Assay Development Laboratory, Scientific Review, Data Management, Quality Assurance, Information Technology teams and Vendors as necessary in the execution and fulfillment of duties. RESPONSIBILITIES This job description reflects major responsibilities globally and is not intended to reflect all possible duties and responsibilities for each employee in this job title. Management has the right to assign all or a portion of the duties and responsibilities of this job based upon business needs. Provides input into Global Laboratory Harmonization and reviews local laboratory requirements for new studies, responds to technical inquiries and provides technical documents and data either directly or by maintaining study specific databases. Provides support for test code requirement collation and submissions for in house and send out tests. (new not in JD) Monitors the local Technical Support Helpdesk, responding to inquiries from other departments and clients requesting specific laboratory information. Provides technical information to other departments and communicates on a technical level with manufacturers, global organizational colleagues as related to their daily activities on both a regional or global basis. Qualifications REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Knowledge of clinical laboratory regulations, GxP and /or ICH guidelines Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures Proficiency in PC applications such as word processing, spreadsheets, database management Excellent attention to detail, organizational skills, verbal and written communication skills Ability to work independently as well as in a team environment Ability to establish and maintain effective working relationships with coworkers, managers and clients

Software Engineer


Experience: 0-3

Function: IT Software : Software Products & Services