Specialist Quality Control at BioPharma Consulting JAD Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

01 Aug, 26

Salary

0.0

Posted On

03 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Molecular biology, Microbiology, GMP, GLP, Assay development, Laboratory testing, Data analysis, Technical writing, Project management, Quality systems, Validation, Compliance, Troubleshooting, Regulatory affairs, Equipment maintenance

Industry

Biotechnology Research

Description

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 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 Work Schedule Administrative Shift: 8:00 AM – 5:00 PM Flexibility required to support non-standard hours based on business needs and project priorities

Responsibilities

The Specialist serves as a technical expert in molecular biology and microbiology, providing guidance and resolving complex laboratory testing issues. They ensure compliance with regulatory standards, manage cross-functional projects, and lead laboratory investigations.