QC Microbiologist II

ABL Home•Rockville, MD

8d•Onsite

About The Position

The QC Microbiologist II will have several responsibilities in the QC group. The analyst will perform environmental monitoring (EM) for particulates and viables in support of cGMP manufacturing which includes several production suites of ISO class 5, 7, and 8 as well as EU Grade A to D in a GMP facility that produces biopharmaceuticals (vaccines, biologics, viral vaccines, monoclonal antibodies, etc.). In addition, monitoring of purified water, and compressed gases systems is required. Additional responsibilities may include EM data review and compilation of data, report writing, and trending of data; investigations, gowning training, and annual gowning qualification. Perform environmental monitoring for HVAC (viable air, viable surface, total particulates), personnel monitoring, purified water (conductivity, TOC, bioburden). Perform entry of data as needed into EM database. Assist in generation of quarterly and annual trend reports. Participate in visual inspection program of final products as part of fill-finish activities. Perform sample log-in, assignment of accession numbers and coordinate shipment of samples to outside test labs. Perform microbiological testing such as: bioburden, endotoxin, growth promotion, etc. Assist quality record completion (OOS, EM investigations, deviations, change control, CAPAs). Support product labeling and packaging activities. Assist raw material release activities. Perform QC Laboratory testing accurately and to schedule as per written procedures. Record all data, observations and QC results accurately with attention to detail. Order and maintain laboratory reagents and supplies. Vaccination in support of upcoming projects. Other duties as assigned.

Requirements

Bachelor’s degree in microbiology, biology or related scientific field
A minimum of 3 years' related experience with biological products in a GMP Quality Control laboratory.
Experience performing EM, purified water sampling, and testing
Requires excellent written and verbal communication skills.
Computer (PC) and software skills including MS Office Suite, Excel, and Word programs.
Must have experience with cGMP and quality systems including OOS and EM investigations, deviations, change control and CAPAs.
High attention to detail, excellent organizational skills, and the ability to work on multiple projects with tight deadlines.
Demonstrated ability to work independently as well as be a strong team contributor
Strong communication
Takes initiative
Works well with all types of people
Remains calm under pressure
Must comply with all immunizations required by the company, regulatory agencies, applicable law, and Occupational Health protocols as a condition of employment, as this position requires access to laboratory, laboratory support areas, and handling of biological materials.

Nice To Haves

Experience with bioburden, endotoxin, TOC, and conductivity a plus.

Responsibilities

Perform environmental monitoring (EM) for particulates and viables in support of cGMP manufacturing.
Monitor purified water and compressed gases systems.
Perform EM data review and compilation of data, report writing, and trending of data.
Conduct investigations, gowning training, and annual gowning qualification.
Perform environmental monitoring for HVAC (viable air, viable surface, total particulates), personnel monitoring, purified water (conductivity, TOC, bioburden).
Perform entry of data as needed into EM database.
Assist in generation of quarterly and annual trend reports.
Participate in visual inspection program of final products as part of fill-finish activities.
Perform sample log-in, assignment of accession numbers and coordinate shipment of samples to outside test labs.
Perform microbiological testing such as: bioburden, endotoxin, growth promotion, etc.
Assist quality record completion (OOS, EM investigations, deviations, change control, CAPAs).
Support product labeling and packaging activities.
Assist raw material release activities.
Perform QC Laboratory testing accurately and to schedule as per written procedures.
Record all data, observations and QC results accurately with attention to detail.
Order and maintain laboratory reagents and supplies.
Vaccination in support of upcoming projects.
Other duties as assigned.