QC Microbiology Associate

Wheeler Bio is seeking a motivated, structured individual with a passion for quality and fast-paced environments to join the Quality Control team. The Microbiology Associate will be responsible for performing various activities within the QC department, such as collecting samples, generating and reviewing of environmental data, as well as routine analysis of samples and media for release and stability testing.

Responsibilities:

• Independently performs routine testing activities, growth promotion of media, bioburden, and endotoxin.
• Perform routine and requested environmental sampling for air, surfaces and personnel within GMP cleanrooms and during product fill activities (i.e., cell banking, Drug Substance Fills, etc.).
• Follows all SOPs, TMs and cGMP as they relate to established processes for laboratory operations and execution of routine testing for release and/or stability samples.
• Generation of routine cGMP and R&D reports with a focus on quality and timeline.
• Competently performs peer review of data.
• Maintains a safe working environment by adhering to company policies and procedures.
• Maintain inventory of materials and contribute to the general organization of the laboratory.
• Support validation activities for facility and fill performance qualifications.
• Assist with maintenance activities of microbiology equipment and ensure the equipment is in good working order to obtain reliable data.
• Generate test reports based on findings and communicate the results (e.g., OOS, etc.) against specifications.
• Perform root cause analysis investigation and corrective actions, as applicable.
• Ability to work with team members to troubleshoot and solve problems to meet project needs.
• Generate SOPs and assist with the generation of company policies, protocol creation, transfer protocols, new method creation, etc.
• Other duties as assigned.

Candidate Required Qualifications:

• Bachelor’s degree in a relevant scientific field or equivalent experience in microbiology testing and/or environmental monitoring within a regulated industry.
• Familiarity with cGMP and relevant quality standards and regulatory requirements.
• Excellent communication and organizational skills.
• Previous experience in environmental monitoring or fieldwork is advantageous.
• Familiarity with environmental monitoring equipment, data analysis software, and sampling techniques. Demonstrated proficiency in aseptic techniques.
• Ability to perform physical work including lifting equipment and working in cleanrooms, requiring gowning.
• Attention to detail and precision in data collection and reporting.
• Strong problem-solving skills and ability to troubleshoot equipment.
• Ability to work independently and as part of a team.
• Strong written and verbal communication skills.
• Knowledge of environmental regulations and laws.

Why Wheeler Bio?

• Opportunity to work with cutting-edge biotechnology in a rapidly growing field.
• Competitive compensation and benefits package.
• Collaborative and inclusive work environment.
• Professional development and growth opportunities.