Quality Control - QC Microbiology Analyst II

Minaris • Allendale, NJ

2d • Onsite

About The Position

Position Summary The Quality Control Microbiology Analyst II 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 work schedule for this role is Wednesday - Saturday from 6:30am - 5:00pm. Essential Functions and Responsibilities Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice. 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 departmentsAssist with routine laboratory testing Inventory Management of lab materials and instrumentsShipping of test samples and equipment to contract laboratories for testing Maintain laboratory audit readiness/Good Laboratory housekeeping practices Any additional request, per management needsComplete all documentation according to written Standard Operating Procedures in accordance with 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.

Requirements

• 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
• 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 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

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 with 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level