QC Microbiology-Environmental Monitoring Analyst

Position Summary

The Quality Control Microbiology Analyst I (2nd shift Wednesday-Saturday, 3:00PM-2:30AM) serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring.

• Environmental monitoring in controlled rooms: perform Non-viable and viable monitoring, Active viable air, Personnel monitoring, Surface sampling, Passive air monitoring, Equipment EM monitoring.
• Perform plate reads and incubations.
• Environmental Monitoring data review and EM trending.
• Ensure equipment is properly maintained/calibrated and monitored in Vaisala system.
• Initiate quality events in Veeva and triage events with outside departments.
• Assist with routine laboratory testing.
• Inventory Management of lab materials and instruments.
• Shipping of test samples and equipment to contract laboratories for testing.
• Maintain laboratory audit readiness / Good Laboratory housekeeping practices.
• Any additional request, per management needs.
• Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

Regular and reliable attendance on a full-time basis. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.

• Knowledge of quality systems and ability to interpret quality standards for implementation and review.
• Strong written and oral communication skills.
• Technical writing skills.
• Technical training experience.
• Detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.

• BA/BS in a science or relevant field required or equivalent experience.
• Minimum 0-2 years of experience or equivalent experience.
• Experience in Environmental monitoring or within the biopharmaceutical industry experience preferred.
• Proficient with computer software such as Microsoft Office, MODA/LIMS.
• Must be flexible with Production schedule which may require coming in early or working later.

(2nd shift Wednesday-Saturday, 3:00PM-2:30AM)

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.