Under general direction, the Specialist Quality Control serves as the technical expert for testing, method development, and troubleshooting in molecular biology and microbiology. This role addresses complex technical issues with impact across multiple organizations, sites, and external partners. The specialist provides advanced scientific guidance, ensures compliance, leads investigations, and supports the development, validation, and continuous improvement of analytical methods and laboratory programs.
FUNCTIONS
- Provide technical guidance to QC and cross‑functional teams; ensure effective communication and follow‑up across sites.
- Troubleshoot and resolve complex assay‑related issues in molecular biology and microbiology.
- Perform advanced data analysis, trending, and interpretation to support decision‑making.
- Serve as subject matter expert (SME) for technical training and laboratory practices.
- Perform routine laboratory work in area of expertise as needed.
- Ensure laboratory compliance with GMP, GLP, safety, and regulatory expectations.
- Develop, revise, and audit complex controlled documents with multi‑site or multi‑functional impact.
- Approve laboratory investigations and lead audit teams.
- Prepare written responses and interact with regulatory agencies as required.
- Evaluate compliance issues and ensure documentation meets internal and regulatory standards.
- Manage existing programs and develop/implement new processes, methodologies, and laboratory initiatives.
- Support method validation, qualification, and transfer activities.
- Represent QC on cross‑functional and multi‑site teams; independently drive completion of action items.
- Resolve issues requiring coordination with external partners or resources.
- Lead special projects assigned by leadership; may supervise employees to meet technical requirements.
SKILLS
- Extensive knowledge of analytical testing, assay development, validation, and method lifecycle activities.
- Strong understanding of pharmaceutical/biological product testing requirements.
- Advanced knowledge of GMPs, CFRs, and U.S. regulatory expectations; familiarity with international regulations.
- Proficient in equipment operation, troubleshooting, and maintenance within area of expertise.
- Advanced scientific data analysis, interpretation, and trending skills.
- Strong knowledge of quality analytical lab processes, validation, QA, manufacturing, and process development.
- Ability to evaluate compliance issues and document according to company and regulatory guidelines.
- Excellent organizational and project management skills; ability to manage multiple priorities.
- Ability to independently understand, implement, and execute complex instructions.
- Experience initiating, coordinating, and leading cross‑functional teams.
- Excellent communication, facilitation, and presentation skills.
- Strong technical writing skills for reports, investigations, and regulatory documentation.
- Ability to interact effectively with regulatory agencies, both orally and in writing.
- Strong leadership, influence, negotiation, and team‑building skills.
- Ability to work independently and collaborate across all organizational levels.
Requirements
EDUCATION & EXPERIENCE REQUIREMENTS
- Doctorate OR
- Master’s + 2 years of directly related experience OR
- Bachelor’s + 4 years of directly related experience OR
- Associate’s + 8 years of directly related experience OR
- High School/GED + 10 years of directly related experience
Preferred:
- Scientific background in Biochemistry, Chemistry, or Microbiology.
PREFERRED QUALIFICATIONS
- Experience in method validation, method transfer, and method qualification.
- Strong project management capability and ability to work with multi‑functional teams.
- Excellent communication skills in English and Spanish.
- Demonstrated ability to lead technical initiatives across multiple sites.
Benefits
Administrative Shift
6-month contract with possible extension