Jt202 - Specialist Quality Control

Quality Consulting Group•Juncos, PR

15d

About The Position

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.

Requirements

Bachelor’s degree in preferable Scientific Background (Science or Engineering) with experience in Pharmaceutical Industry, Quality Control, Laboratory Testing, Project Management and Quality processes.
Scientific Data Analysis
Strong knowledge in Microsoft Excel as a Tool for Data Analysis.
Knowledge in Computer System and Method Validation (Experience preferable).
Strong knowledge and experience with quality process management.
Experience on Equipment Validation and troubleshooting.
Ability to develop inspection or qualification protocols in a short timeframe period.
Proven Experience using KNEAT platform and Kaye validator.

Nice To Haves

Preferable experience as Microbiologist, Chemist, Biochemistry, Molecular Sciences, or Chemical Engineering.

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.