Quality Control Microbiologist

Anika Therapeutics•Bedford, MA

75d•$66,000 - $75,000•Onsite

About The Position

The QC Microbiologist performs microbiological testing and validation activities supporting commercial manufacturing operations under GMP conditions, ensuring compliance with regulatory requirements, product quality standards, and environmental monitoring programs. In this role, you serve as a subject matter expert in microbiological testing, environmental monitoring, and validation activities for sterile manufacturing processes and systems.

Requirements

Bachelor’s degree in Microbiology, Biology, or related scientific discipline; equivalent experience may be considered.
Minimum of 1 year of pharmaceutical or regulated industry experience performing microbiological testing.
Hands-on experience with sterility, bioburden, endotoxin (LAL), microbial identification, gram staining, purified water testing, bacteriostasis, and growth promotion assays.
Experience supporting validation activities, including new product validation, microbiological method validation, and equipment validation.
Knowledge of GMP, GLP, FDA regulations, and applicable ISO requirements.
Experience supporting environmental monitoring programs within classified cleanroom environments.
Excellent written and verbal communication skills.
Demonstrated ability to manage testing schedules, meet reporting deadlines, and maintain accurate documentation.
Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint.

Nice To Haves

Experience with aseptic processing environments and media fill evaluations.
Familiarity with autoclave and depyrogenation oven validation activities.
Experience maintaining environmental monitoring trending databases and generating annual reports.
Prior experience supporting internal audits or regulatory inspections.
Knowledge of USP microbiological testing requirements and contamination control principles.

Responsibilities

Perform microbiological testing including bioburden, sterility, endotoxin, microbial identification, gram staining, bacteriostasis, and growth promotion assays for raw materials, in-process samples, bulk products, finished products, and stability samples.
Conduct purified water and DI water testing, including bioburden, endotoxin, membrane filtration, and TOC testing in accordance with USP requirements.
Complete laboratory documentation, test records, and related activities in compliance with SOPs, GMPs, and data integrity requirements.
Support development, qualification, and validation of microbiological methods, including new product sterility and endotoxin testing methods.
Author, execute, review, and approve validation protocols and reports related to microbiological methods, autoclaves, depyrogenation ovens, and related systems.
Collaborate with Engineering and R&D to support process validation, equipment validation, and new product introduction activities.
Review environmental monitoring results for classified cleanroom areas, maintain environmental monitoring databases, and summarize data for annual environmental reports.
Support environmental monitoring programs and provide guidance and training on environmental compliance practices.
Verify laboratory testing performed by technicians and assist in onboarding and technical training activities.
Establish and maintain databases for microbiological testing and validation data.
Participate in internal audits and support regulatory inspections and audit readiness activities.
Perform other duties and projects as assigned.