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:
- Functions as the technical specialist for testing & 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
- Represents the department/organization on various teams, independently responsible for following through on multi-site action items.
- Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.
Qualifications:
- Bachelors degree & 5 years of directly related experience
- Knowledge on Laboratory Analytical Assets
- GMP Documentation
- Computerized Maintenance ( Asset / PM creation, Documentation, etc..)
- Good Written and Communication Skills
- Advanced scientific data analysis and interpretation
- Ability to interact with regulatory agencies both orally and in writing. Initiate, coordinate and lead cross functional teams.
- 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
- Administrative Shift 8:00am to 5:00pm
Top Skills
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.
Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
