Contamination Control & Sterility Assurance Specialist
Cytiva
Westborough, MA
5 days ago
Job Description
Join Cytiva as a Contamination Control & Sterility Assurance Specialist, where you'll play a crucial role in ensuring compliance and integrity in a highly regulated medical device environment. You'll conduct laboratory analyses, provide training, and manage critical processes, contributing to life-saving innovations in healthcare.
Key Responsibilities
Perform laboratory analysis of samples using aseptic techniques and following established procedures.
Provide support to other sites as a Contamination Control and Sterility Assurance Specialist.
Provide subject matter expertise and training in environmental monitoring, QC testing, and sterility assurance.
Manage sterilization requests, coordinate schedules with suppliers, and monitor inventories of samples.
Ensure compliance with industry standards and regulatory requirements.
Required Qualifications
Bachelor’s degree in Biology, Microbiology, Biotechnology, or a related scientific field.
3+ years of experience in a Quality Control microbiology laboratory.
Strong knowledge of aseptic techniques, environmental monitoring, microbiological QC testing, and sterility assurance processes.
Deep understanding of ISO 14644, sterility processes, and cGMP in medical device product manufacturing.
Experience with Water, Endotoxin, Bioburden, Conductivity, and TOC testing.
Preferred Qualifications
Familiarity with Electronic Management Systems (e.g., Veeva, Magic) and proficiency in Excel, Word, and PowerPoint.
Proven experience in working with environmentally trending data and analysis.