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Specialist Quality Control (Investigations)

Juncos, Puerto Rico
DESCRIPTION
We are seeking a Specialist Quality Control for testing & development in areas of molecular biology and microbiology.
 
EDUCATION
Doctorate degree or master’s degree in Sciences and 3 years of directly related experience or bachelor’s degree in Sciences and 5 years of directly related experience.
 
REQUIREMENTS
  • 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.
 
SKILLS
  • Excellent communication skills, facilitation, and presentation skills.
  • Excellent technical writing skills.
  • Strong computer operation skills including work processing, presentation, database, and spreadsheet application skills,
  • Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions, and follow assignments through to completion.
  •  Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
  • Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
  • Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
  • Knowledge of pharmaceutical processes,
  • Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
  • Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
  • Extensive knowledge and application of GMPs/CFRs.
  • Ability to evaluate compliance issues.
  • Skill in evaluating and documenting according to Company and various guidelines.
  • Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
  • Advanced scientific data analysis and interpretation skills.
  • Advanced skills in solving complex problems.
  • Advanced data trending and evaluation.
  • Strong skill in working independently and to effectively interact with various levels.
  • Ability to interact with regulatory agencies both orally and in writing. Initiate, coordinate and lead cross functional teams.
  • Excellent skill in leading, motivating, influencing, and negotiating.
 
 
Ultimate Solutions Corp is an Equal Opportunity Employer.
 
 

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