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jt863 - specialist quality control

3 weeks ago

Juncos, United States Quality Consulting Group Full time

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

  • Responsible for providing technical guidance, provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
  • Resolve technical issues and troubleshoot for assays as necessary.
  • Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
  • Manage existing and/or develop and implement new programs, processes and methodologies.
  • Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
  • Approve lab investigations, lead audit teams.
  • May serve as subject matter expert to develop technical training.
  • May perform routine work in a specific area of responsibility as necessary.
  • Represents the department/organization on various teams, independently responsible for following through on multi-site action items.
  • May interact with regulatory agencies regarding area(s) of responsibility including written responses.
  • May resolve issues with outside resources.
  • Performs special projects as requested by supervisor, may supervise employees as necessary to meet technical requirements.
     
Qualifications:
  • Bachelor's degree in preferably with Scientific Background (Science or Engineering) with experience in Pharmaceutical Industry, Quality Control, Laboratory Testing, Project Management and Quality processes.
  • +4 years of directly related experience. (Preferable experience as Microbiologist, Chemist, Biochemistry, Molecular Sciences, or Chemical Engineering).
  • Knowledge of pharmaceutical processes.
  • Extensive knowledge and application of GMPs/CFRs.
  • Knowledge in Scientific Data Analysis.
  • Strong Technical Writing (English and Spanish) mainly focuses.
  • Strong knowledge in Microsoft Excel as a Tool for Data Analysis.
  • Good Communication skills
  • Project Management skills
  • Knowledge in Computer System and Method Validation (Experience preferable)
  • Strong knowledge and experience with quality process management.
  • Basic Knowledge on equipment preventive maintenance and troubleshooting.
  • Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
  • Agile on prioritization of critical tasks.
  • Ability to develop inspection or qualification protocols in a short timeframe period.
  • Strong negotiation skills
  • Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.