JT175 - SPECIALIST QUALITY CONTROL

Juncos, Puerto Rico

Contracted

Biopharmaceutical

Experienced

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:

Technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
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.
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.

Qualifications:

Bachelor’s degree in preferably in Engineering (Chemical, Environmental, Mechanical, Electrical), or Chemist/Biology (with experience in Equipment Validation)
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.
Laboratory Equipment Validation
Periodic Monitoring
Periodic Review
Equipment Data Integrity
Equipment Procurement
Decommissioning process
New equipment Introduction and Maintenance
Biochemistry (eg. Compendial testing, physical methods)
High-Performance Liquid Chromatography (HPLC)
Microbiology (eg. Sterility, Endotoxin, Bioburden)
Availability for 1st or 2nd 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.

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