Quality Control Specialist 2982656 (Biotechnology Industry)
๐ข Now Hiring: Specialist - Quality Control
Location: Juncos, PR
Work Arrangement: 100% Onsite โ Administrative Shift
Duration: Approximately 6 months
Positions Available: 1
Summary
Our client is seeking a highly skilled Specialist - Quality Control to function as a technical expert in laboratory testing and development, specifically in molecular biology and microbiology. This role will focus on resolving complex technical issues across multiple teams and sites while ensuring compliance with GMP and GLP regulations. The ideal candidate will bring expertise in analytical laboratory assets, documentation, and computerized maintenance.
Education & Experience Requirements
Candidates must meet one of the following qualifications:
Doctorate Degree โ No prior experience required
Masterโs Degree โ Minimum 3 years of directly related experience
Bachelorโs Degree โ Minimum 5 years of directly related experience
Associateโs Degree โ Minimum 10 years of directly related experience
High School Diploma/GED โ Minimum 12 years of directly related experience
Preferred Qualifications
โ Knowledge of Laboratory Analytical Assets
โ Proficiency in GMP Documentation
โ Experience in Computerized Maintenance (Asset/PM creation, documentation)
โ Strong written and verbal communication skills
๐ Key Responsibilities
๐น Serve as a technical specialist for molecular biology and microbiology testing & development.
๐น Provide technical guidance and ensure smooth communication between technical groups.
๐น Troubleshoot and resolve technical issues related to assays.
๐น Ensure lab compliance by implementing procedures that enhance GMP, GLP, and safety standards.
๐น Manage and develop new programs, processes, and methodologies to improve laboratory operations.
๐น Revise and audit complex controlled documents impacting multiple organizations or sites.
๐น Lead and approve lab investigations and participate in audit teams.
๐น May act as a subject matter expert (SME) to develop technical training programs.
๐น Represent the department on various teams and interact with regulatory agencies when required.
๐น Coordinate and lead cross-functional teams to address compliance and quality issues.
๐น Perform special projects as assigned by leadership.
๐น May supervise employees to ensure technical requirements are met.
Competencies & Skills
- Excellent communication, facilitation, and presentation skills
- Strong technical writing abilities for documentation and regulatory responses
- Proficiency in computer applications including word processing, databases, and spreadsheets
- Project management and organizational skills to handle multiple tasks and priorities
- Deep understanding of quality analytical labs, validation, manufacturing, and quality assurance processes
- Expertise in U.S. and international pharmaceutical regulations for testing biological products
- Advanced problem-solving and data analysis skills
- Ability to work independently and interact with multiple stakeholders
- Experience leading, motivating, influencing, and negotiating within teams
๐ฉ Ready to take the next step in your career? Apply today and be part of a team that drives excellence in pharmaceutical quality control! ๐