QC Microbiology Analyst II

Minaris•Allendale, NJ

1d•Onsite

About The Position

The Quality Control Microbiology Analyst serves as a support role to clinical and 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. This role will be supporting the Microbiology lab by performing Microbial testing for batch release. 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. Perform environmental monitoring in controlled rooms: Non-viable and viable monitoring, Active viable air, Personnel monitoring, Surface sampling, Passive air monitoring, Equipment EM monitoring Data review: EM review, EM trending, MODA approvals, ID reviews. Perform Plate reads and incubations Lot release: Coordinate data for batch release, perform lot release, assist QA with lot release inquiries Ensure equipment is properly maintained/calibrated, trouble shooting, monitoring instruments in Vaisala software, open Work Orders Initiate quality events in Veeva and triage events with outside departmentsInventory Management of lab materials and instruments Maintain laboratory audit readiness/Good Laboratory housekeeping practices Shipping of test samples and equipment to contract laboratories for testing Writing/conducting investigations pertaining to environmental monitoring and microbial testing Perform microbial tests as assigned by management (ie Growth promotion, Microbial Identification, Sterility testing, growth promotion, etc) Review and revise SOPs Train QC Microbiology Analyst I, build training material for departmental training 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.Any additional request, per management needs

Requirements

Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.
Strong written and oral communication skills
Strong 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 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry.
Proficient with computer software such as Microsoft Office, MODA/LIMS
Familiarity with ISO and EU standards
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.
Attend all required Quality & Compliance training at the specified interval.
Employee will work with moderate noise level.
Employee will perform tasks while experiencing numerous interruptions.
The work environment is fast paced.
This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct.
Off-shift, weekend and overtime duties may be required.
While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills.
Must be able to work during the weekend, holidays and as required by the company
The work environment requires gowning, hair net, safety glasses, gloves, and foot coverings.
This role operates within a professional office environment of a manufacturing operations plant.
This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
Seating is mixed and includes open space seating, cubicle, and office space.
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens, proper PPE must be worn.
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
Other exposures may include gases (nitrogen), or corrosive sanitizing chemicals (Clorox, Hydrogen peroxide), or exposure to liquid nitrogen.
The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period (4-5 hours).
Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator
The employee is frequently required to lift, move, or carry up to 25 pounds.
This role is occasionally sedentary. Sedentary entails sitting most of the time but may involve walking or standing for brief periods.
Gowning proficiency as needed.
Heavy cryo-gloves must be used when working with liquid nitrogenMust be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.
Must be capable of using hands and fingers to operate a computer and other office productivity machinery
Must have the ability to communicate information and ideas so others will understand.
Must be able to exchange accurate information in person, and on the telephone.
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
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
Other exposures may include gases (nitrogen), or corrosive sanitizing chemicals (Clorox, hydrogen peroxide), or exposure to liquid nitrogen.
This role operates within a professional office environment of a manufacturing operations plant.
This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
Seating is mixed and includes open space seating, cubicle, and office space.

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
Data review: EM review, EM trending, MODA approvals, ID reviews.
Perform Plate reads and incubations
Lot release: Coordinate data for batch release, perform lot release, assist QA with lot release inquiries
Ensure equipment is properly maintained/calibrated, trouble shooting, monitoring instruments in Vaisala software, open Work Orders
Initiate quality events in Veeva and triage events with outside departmentsInventory Management of lab materials and instruments
Maintain laboratory audit readiness/Good Laboratory housekeeping practices
Shipping of test samples and equipment to contract laboratories for testing
Writing/conducting investigations pertaining to environmental monitoring and microbial testing
Perform microbial tests as assigned by management (ie Growth promotion, Microbial Identification, Sterility testing, growth promotion, etc)
Review and revise SOPs
Train QC Microbiology Analyst I, build training material for departmental training
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.
Any additional request, per management needs