Quality Control Specialist (Biotechnology Industry) 29996004

Specialist Quality Control (Biotechnology Industry) – 29996004

📍 Location: Juncos, PR (100% Onsite)

⏳ Shift: Administrative (8:00 - 5:00 PM)

📆 Duration: Approximately 11 months

👥 Openings: 1

Job Summary

Under general direction, the Specialist Quality Control serves as a technical specialist in molecular biology and microbiology testing and development. This role focuses on resolving complex technical issues across multiple organizations, sites, and external resources.

Key Responsibilities

• Provide technical guidance and support for laboratory operations.
• Conduct data analysis, reporting, and communication between technical groups.
• Troubleshoot and resolve technical issues related to assays as needed.
• Ensure compliance with GMP, GLP, and safety regulations, implementing procedures to enhance compliance.
• Develop, revise, and audit complex controlled documents with multi-site impact.
• Approve laboratory investigations and ensure compliance with quality standards.
• Lead audit teams and serve as a subject matter expert for technical training.
• Represent the department in cross-functional teams and manage multi-site action items.
• Interact with regulatory agencies and provide written responses as needed.
• Coordinate and lead special projects as assigned.
• Supervise employees when required to meet technical and operational needs.

Education & Experience Requirements

Candidates must meet one of the following qualifications:

• Ph.D. in Chemistry, Microbiology, Biology, or Life Sciences – No prior experience required.
• Master’s degree with 3+ years of directly related experience.
• Bachelor’s degree with 5+ years of directly related experience.
• Associate degree with 10+ years of directly related experience.
• High school diploma/GED with 12+ years of directly related experience.

Preferred Qualifications

• Laboratory experience in a GMP environment within the Pharmaceutical or Biotechnology industry.
• Fully bilingual (English & Spanish) with strong communication skills.

Key Competencies & Skills

✅ Technical & Compliance Expertise:

• Strong understanding of GMP, GLP, and CFR regulations in pharmaceutical/biological testing.
• Extensive knowledge of quality analytical labs, validation, manufacturing, and quality assurance.
• Advanced skills in scientific data analysis, trending, and interpretation.

✅ Problem-Solving & Project Management:

• Ability to handle multiple responsibilities and shift priorities effectively.
• Strong project management and organizational skills.
• Advanced skills in troubleshooting and problem resolution.

✅ Leadership & Communication:

• Excellent technical writing, facilitation, and presentation skills.
• Experience in leading, influencing, and negotiating across teams.
• Ability to interact with regulatory agencies both orally and in writing.

✅ Technical & Computer Skills:

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, databases, spreadsheets).
• Strong knowledge of pharmaceutical processes, validation, and assay development.

If you meet the qualifications and are interested in this exciting opportunity, we encourage you to apply inside the job description with an updated resume! 📩