Quality Control Specialist (Biotechnology Industry)
Job Title: Specialist – Quality Control
Location: East Region, Puerto Rico (Open to Puerto Rico Residents Only)
Shift: 100% Onsite | Administrative Shift
Duration: Approximately 5 Months
Positions Available: 1
Summary
Our client is seeking a Specialist in Quality Control to provide technical expertise in molecular biology and microbiology within a regulated pharmaceutical environment. This role will focus on testing, development, data analysis, and cross-functional communication, supporting multi-site initiatives with a strong emphasis on compliance, quality processes, and laboratory excellence.
Education Requirements (One of the following must be met):
- Doctorate (PhD)
- Master’s Degree + 2 years of directly related experience
- Bachelor’s Degree + 4 years of directly related experience
- Associate Degree + 8 years of directly related experience
- High School Diploma/GED + 10 years of directly related experience
Preferred Background & Skills
- Academic background in Science or Engineering
- Experience in Pharmaceutical Industry, Quality Control, Laboratory Testing, and Quality Processes
- Experience in roles such as Microbiologist, Chemist, Biochemist, Molecular Scientist, or Chemical Engineer
Preferred Qualifications
- Strong scientific data analysis capabilities
- Advanced technical writing skills in English and Spanish
- Proficient in Microsoft Excel for data analysis
- Excellent communication and project management skills
- Knowledge in computer systems and method validation (preferred)
- Familiarity with preventive maintenance and troubleshooting of laboratory equipment
- Ability to prioritize critical tasks efficiently
- Experience developing inspection or qualification protocols within tight deadlines
- Strong negotiation skills
Key Responsibilities
- Provide technical guidance and lead troubleshooting activities for assays
- Conduct data analysis and report generation to support decision-making
- Ensure lab compliance with GMP, GLP, and safety standards
- Lead or contribute to the development and implementation of new programs, methods, and procedures
- Review and revise controlled documents with cross-organizational impact
- Approve laboratory investigations and support audits
- Act as Subject Matter Expert (SME) for technical training development
- May perform hands-on testing or supervise other employees as needed
- Represent the department in internal and external meetings
- Participate in or lead regulatory interactions, including drafting responses
- Coordinate with external resources and lead special projects
Competencies & Skills
- Strong alignment with our client’s values
- Excellent communication, facilitation, and presentation skills
- Advanced computer skills (Word, Excel, PowerPoint, databases)
- Exceptional project management and organizational capabilities
- Ability to manage multiple responsibilities, shifting priorities as needed
- Deep knowledge of lab quality processes, validation, and GMP operations
- Experience in analytical test development and assay validation
- Strong understanding of U.S. and international regulatory standards
- Ability to identify and address compliance issues
- Proficiency in documentation practices and regulatory writing
- Skilled in equipment troubleshooting and maintenance
- Advanced problem-solving, data trending, and evaluation abilities
- Ability to collaborate across departments and interact with regulatory agencies
- Leadership in cross-functional teams, motivating others, and driving results
If you are a proactive and skilled professional in Quality Control looking for an opportunity to make a meaningful impact, we encourage you to apply inside the job description link with an updated resume.
📩 We look forward to reviewing your qualifications!