QC Microbiology Analyst I

Minaris•Allendale, NJ

1d•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 role requires adherence to all FDA and Worldwide Quality & Compliance regulations, established procedures, and protocols, prioritizing continuous training and skill development, and upholding the highest standards of data integrity to ensure accuracy, compliance, and operational excellence. This position operates within a professional office environment of a manufacturing operations plant and requires the ability to maintain aseptic behavior within a cleanroom environment for an extended period.

Requirements

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.
Knowledge of quality systems and ability to interpret Quality standards for implementation and review.
Strong written and oral communication skills.
Technical writing skills.
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.
Must have the ability to work in a team-oriented environment and with clients.
Must be able to work during the weekend, holidays and as required by the company.
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
Must be able to handle the standard/moderate noise of the manufacturing facility.
Must be able to maintain aseptic behavior within a cleanroom environment for an extended period (4-5 hours).
Gowning proficiency as needed.
Heavy cryo-gloves must be used when working with liquid nitrogen.

Nice To Haves

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

Responsibilities

Perform environmental monitoring in controlled rooms: non-viable and viable monitoring, Active viable air, Personnel monitoring, Surface sampling, Passive air monitoring, Equipment EM monitoring.
Perform plate reads and incubations.
Review Environmental Monitoring data and perform 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.
Manage inventory of lab materials and instruments.
Ship test samples and equipment to contract laboratories for testing.
Maintain laboratory audit readiness and good laboratory housekeeping practices.
Complete all documentation according to written Standard Operating Procedures in accordance with Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
Exhibit 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.
Embody Minaris Advanced Therapies values and align daily actions with department and company culture.