Quality Control Specialist (3500032)

Title: Quality Control Specialist (3500032)

Location: Puerto Rico (Open to Puerto Rico Residents)

Position: 1

Duration: Approximately 6 months

Work Model: 100% Onsite | Administrative Shift

Contract: This opportunity is by contract with ProQuality Network in representation of our client.

SUMMARY

Under general direction, the Quality Control Specialist functions as a technical expert in molecular biology and microbiology testing and development. This role addresses complex technical matters with multi-organizational and/or multi-site impact, including interactions with external resources as needed.

PREFERRED QUALIFICATIONS

• Scientific data analysis
• Strong technical writing skills (English and Spanish)
• Advanced proficiency in Microsoft Excel for data analysis
• Effective communication skills
• Project management capabilities
• Knowledge of computer systems and method validation (experience preferred)
• Strong understanding of quality process management
• Basic knowledge of equipment preventive maintenance and troubleshooting
• Ability to prioritize critical tasks in a dynamic environment
• Ability to develop inspection or qualification protocols within short timelines
• Strong negotiation skills

FUNCTIONS

• Provide technical guidance, generate reports, perform data analysis, and ensure consistent communication across technical groups, including follow-up and resolution of technical issues.
• Troubleshoot and resolve assay-related technical issues as needed.
• Ensure laboratory compliance by implementing procedures that reinforce GMP, GLP, and safety standards.
• Manage existing programs and/or develop new programs, processes, and methodologies.
• Develop, revise, and audit complex controlled documents with multi-site or multi-organizational impact.
• Approve laboratory investigations and lead audit teams.
• Serve as a subject matter expert in the development of technical training.
• Perform routine work in areas of expertise when necessary.
• Represent the department on cross-functional teams and independently manage multi-site action items.
• Interact with regulatory agencies as needed, including preparation of written responses.
• Resolve issues involving external resources when required.
• Execute special projects assigned by leadership and supervise personnel when necessary to meet technical demands.

EDUCATION REQUIREMENTS

Candidates must meet one of the following:

• Doctorate; 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/GED + 10 years of directly related experience.

COMPETENCIES / SKILLS

• Demonstrate and support our client’s core values.
• Excellent communication, facilitation, and presentation abilities.
• Exceptional technical writing skills.
• Strong computer proficiency (word processing, presentations, databases, spreadsheets).
• Outstanding project management and organizational skills with the ability to implement complex instructions and complete assignments independently.
• Advanced capability to manage multiple priorities and projects simultaneously.
• Extensive knowledge of quality analytical laboratory processes, validation, manufacturing, quality assurance, process development, and distribution.
• Proficiency in assay development, testing, and validation for pharmaceutical/biological products.
• Solid understanding of pharmaceutical processes and U.S. regulatory requirements, with basic knowledge of international regulations.
• In-depth understanding of GMPs, CFRs, compliance requirements, and documentation standards.
• Ability to evaluate and document compliance issues accurately.
• Proficiency in equipment maintenance, troubleshooting, and operation within area of expertise.
• Advanced scientific data analysis, data trending, interpretation, and problem-solving skills.
• Strong ability to work independently and communicate effectively across organizational levels.
• Ability to interact professionally with regulatory agencies both verbally and in writing.
• Skilled in initiating, coordinating, and leading cross-functional teams.
• Strong leadership, motivation, influence, and negotiation capabilities.

If you meet the qualifications and are interested in this opportunity, we invite you to apply through the job description link and submit your updated resume for evaluation.