QC Microbiology Analyst I

Minaris Advanced Therapies•Allendale, NJ

17h•Onsite

About The Position

The Quality Control Microbiology Analyst I 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. The shift and schedule for this opportunity is: Wednesday - Saturday 3:30pm - 2:00am

Requirements

Knowledge of quality systems and ability to interpret Quality standards for implementation and review.
Strong written and oral communication skills, and technical writing skills.
Technical training experience.
Must be 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.
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
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.

Nice To Haves

Experience in Environmental monitoring or within the biopharmaceutical industry experience preferred.

Responsibilities

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.