What are the responsibilities and job description for the Quality Control Specialist - Microbiology position at SoTalent?
Role Overview:
This position involves the planning and execution of improvement and compliance initiatives within a quality control microbiology function. Key responsibilities include managing basic projects and creating essential documentation such as change records, study plans, reports, and submissions for regulatory bodies. The role also requires providing technical expertise and supporting investigations related to QC microbiology systems and testing methodologies. The individual will be self-directed, operating with minimal direct supervision and reporting to the head of the quality control laboratory.
Key Contributions:
- Leading projects across various work schedules within the QC microbiology department, potentially including the indirect oversight of assigned personnel.
- Collaborating with different departments and influencing decisions to advance QC microbiology priorities and project goals.
- Developing project plans, managing change control processes, creating study protocols and final reports, revising standard operating procedures, and overseeing relevant documentation for the QC microbiology area.
- Reviewing global documentation for local adherence and identifying gaps within the QC microbiology function.
- Maintaining and compiling QC microbiology performance indicators, including trend analysis (e.g., environmental monitoring data).
- Conducting assessments to ensure compliance with global standards and regulatory requirements.
- Managing QC microbiology standard operating procedures to ensure adherence to relevant guidelines (e.g., FDA, QSR, cGMP) while driving process enhancements.
- Applying statistical methods and maintaining current knowledge of relevant regulations (e.g., CFR, USP). Utilizing laboratory information management systems (LIMS) or similar platforms for test result entry, approval, and tracking.
- Representing the laboratory in cross-functional teams for operational, project-related, or investigational activities aimed at improving efficiency, cost-effectiveness, quality, and new product support.
- Maintaining the work area in compliance with good manufacturing practices (GMP) while adhering to environmental, health, and safety (EHS) and lean principles (e.g., 5S). Ensuring training compliance, maintaining up-to-date training records, and providing training to staff on project requirements.
- Handling the disposal of hazardous waste according to established procedures.
- Demonstrating proficiency in relevant laboratory software applications.
- Providing technical, operational, and general GMP guidance to other laboratory personnel.
- Serving as a subject matter expert on the technical aspects of QC microbiology. Contributing to laboratory audit readiness efforts by understanding regulatory and quality requirements.
- Maintaining a strong understanding of current regulations and acting as a laboratory resource for compliance.
- Understanding and applying cGMP/DPD principles, following established procedures (CTP/SOPs), and adhering to EHS guidelines.
- Strong written and verbal communication skills in English are essential.
Requires bachelor's degree in science, engineering, or other related technical field. Bachelor's degree in microbiology or Biological Science.
Minimum 2 years of experience
Salary : $60,000 - $72,000
