Specialist Quality Control
Posted 2 months ago
Under general direction, the Specialist – Quality Control functions as a technical expert in testing and development within molecular biology and microbiology. This role focuses on resolving complex technical issues, supporting multi-site operations, and ensuring compliance with regulatory and quality standards across cross-functional environments.
Key Responsibilities
- Provide technical guidance, data analysis, and reporting to support laboratory and quality operations
- Ensure effective communication across technical groups and follow up on issue resolution
- Troubleshoot and resolve complex assay and laboratory testing issues
- Ensure compliance with GMP, GLP, and safety standards
- Develop and implement programs, processes, and methodologies to improve lab performance
- Author, revise, and audit controlled documents with cross-functional and multi-site impact
- Lead and approve laboratory investigations and support audit readiness activities
- Serve as Subject Matter Expert (SME) and develop technical training as needed
- Represent the function on cross-functional teams and ensure completion of assigned action items
- Interface with regulatory agencies, including preparation of responses when required
- Manage issues involving external vendors or partners
- Support or lead special projects and supervise personnel when necessary
Required Skills & Competencies
- Strong knowledge of GMP, GLP, CFRs, and regulatory requirements for pharmaceutical/biological testing
- Expertise in assay development, validation, and laboratory testing
- Advanced data analysis, trending, and interpretation skills
- Strong technical writing skills (English and Spanish preferred)
- Proficiency in Microsoft Office, especially Excel for data analysis
- Strong project management and organizational skills
- Ability to troubleshoot complex technical issues and drive solutions
- Experience with quality systems, validation, and compliance processes
- Ability to lead cross-functional teams and manage multiple priorities
- Strong communication, facilitation, and presentation skills
- Knowledge of equipment maintenance and troubleshooting
- Ability to evaluate compliance risks and implement corrective actions
Requirements
Education & Experience
- Doctorate degree OR
- Master’s degree + 2 years of directly related experience OR
- Bachelor’s degree + 4 years of directly related experience OR
- Associate’s degree + 8 years of directly related experience OR
- High School Diploma/GED + 10 years of directly related experience
Preferred Background:
- Degree in Science or Engineering (e.g., Microbiology, Chemistry, Biochemistry, Molecular Sciences, Chemical Engineering)
- Experience in pharmaceutical or biotechnology industry, particularly in Quality Control, laboratory testing, and quality systems
Preferred Qualifications
- Experience in method validation, method transfer, and computer system validation (CSV)
- Strong scientific data analysis and reporting capabilities
- Experience with sample management processes
- Ability to develop inspection or qualification protocols under tight timelines
- Strong negotiation and influencing skills
- Ability to prioritize critical tasks in a fast-paced environment
Benefits
Work Schedule
- Administrative Shift: 8:00 AM – 5:00 PM
- Flexibility required to support non-standard hours based on business needs and project priorities
Other open roles at BioPharma Consulting JAD Group(6)
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
Key team members
Peter G. Mescia, MBA, PMP
Zuleimy Torres
Carlos Rosado
Jorge Torres
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