Quality Control Specialist (Regulated Industry) 3562890
Job Description
Job Description
Job Title: Quality Control Specialist (Regulated Industry) – 3562890
Location: Puerto Rico (100% Onsite)
Positions Available: 3
Duration: Approximately 6 Months
Work Schedule: Availability to work administrative and non-standard shifts
Eligibility: Open to Puerto Rico residents
Position Summary
Our client is seeking a Quality Control Specialist to support laboratory operations within a highly regulated environment. Under general direction, this role serves as a technical specialist in testing and development within molecular biology and microbiology laboratories.
The position focuses on complex technical challenges and scientific data analysis, often supporting multi-organizational or multi-site initiatives and collaborating with internal and external stakeholders. The successful candidate will contribute to laboratory compliance, technical troubleshooting, scientific reporting, and continuous improvement of quality processes.
Key Responsibilities
- Provide technical guidance, reports, and data analysis, ensuring effective communication among cross-functional technical groups.
- Investigate, troubleshoot, and resolve technical issues related to laboratory assays and testing methods.
- Ensure laboratory compliance with GMP, GLP, and safety standards by implementing and improving procedures.
- Manage existing programs and support the development and implementation of new processes, methodologies, and quality initiatives.
- Develop, revise, and audit complex controlled documentation that may impact multiple organizations or sites.
- Review and approve laboratory investigations and support or lead audit activities.
- Serve as Subject Matter Expert (SME) when required and assist in the development of technical training programs.
- Perform routine laboratory or technical activities as necessary within the area of responsibility.
- Represent the department on cross-functional teams and independently track and complete multi-site action items.
- Interact with regulatory agencies when required, including the preparation of written responses.
- Collaborate with external resources to resolve technical or operational issues.
- Lead or participate in special projects as assigned by leadership.
- Provide supervision or technical direction to staff when necessary to meet project or operational requirements.
Preferred Qualifications
- Scientific background in Science or Engineering with experience in the pharmaceutical or regulated industry.
- Experience in Quality Control laboratories, laboratory testing, method validation, and method transfer.
- Background in disciplines such as:
- Microbiology
- Chemistry
- Biochemistry
- Molecular Sciences
- Chemical Engineering
Additional preferred skills include:
- Scientific data analysis and interpretation
- Strong technical writing skills in English and Spanish
- Advanced Microsoft Excel for data analysis and trending
- Strong communication and collaboration skills
- Project management experience
- Sample lifecycle and sample management processes
- Knowledge of computer system validation and method validation
- Experience with quality process management systems
- Basic knowledge of preventive maintenance and equipment troubleshooting
- Ability to prioritize critical tasks in fast-paced environments
- Capability to develop inspection or qualification protocols within tight timelines
- Strong negotiation and problem-solving skills
Education Requirements
One of the following combinations is required:
- Doctorate in a relevant scientific field, 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.
Core Competencies and Skills
- Excellent communication, facilitation, and presentation skills.
- Strong technical and scientific writing capabilities.
- Advanced computer proficiency, including word processing, presentations, databases, and spreadsheets.
- Strong project management and organizational skills with the ability to independently follow complex instructions through completion.
- Ability to manage multiple priorities, tasks, and projects simultaneously.
- Extensive experience with quality analytical laboratories, validation, manufacturing, quality assurance, process development, and distribution.
- Strong knowledge of assay development, assay validation, and laboratory testing processes.
- Understanding of pharmaceutical manufacturing and analytical processes.
- Strong knowledge of U.S. pharmaceutical regulations and practices for testing biological and pharmaceutical products.
- Familiarity with international regulatory standards and practices.
- Extensive knowledge and application of GMP and CFR regulations.
- Ability to evaluate and document compliance issues in accordance with company procedures and regulatory guidelines.
- Proficiency in equipment operation, maintenance, and troubleshooting within the technical area of expertise.
- Advanced scientific data analysis, data trending, and interpretation skills.
- Strong analytical thinking and complex problem-solving capabilities.
- Ability to work independently and effectively collaborate with cross-functional teams.
- Experience interacting with regulatory agencies both verbally and in writing.
- Ability to lead, coordinate, and motivate cross-functional teams.
If you meet the qualifications and are interested in this opportunity, we encourage you to apply through the job description link and submit your updated resume for consideration.