Specialist Quality Control at Flexible & Integrated Technical Services, LLC

Juncos, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Sep, 26

Salary

0.0

Posted On

06 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Method Validation, Method Transfer, Method Qualification, Project Management, Data Analysis, GMP, GLP, Troubleshooting, Technical Guidance, Auditing, Bilingual English and Spanish, Laboratory Compliance

Industry

Pharmaceutical Manufacturing

Description

For QC Services in the Laboratory area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree with five (5) years of experience within the pharmaceutical or regulated industry. Bilingual (English & Spanish). Project Management skills. Shift: Administrative and according to business needs. Experience in: Method Validation, Method Transfer, Method Qualification. Scientific, Chemistry or Microbiologist. The Personality Part: Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on! AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) 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. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the next piece?

Responsibilities

Provide technical guidance, data analysis, and troubleshooting for assays while ensuring laboratory compliance with GMP and GLP standards. Manage the development of new processes, audit controlled documents, and lead audit teams to maintain quality control.