Job Description
ABL, Inc. is an Equal Opportunity Employer and is committed to embracing diverse backgrounds. ABL, Inc. does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation or any other characteristic protected by federal, state or local law. For more information click here.
Job Title
QC Microbiologist II
Location
Rockville, MD 20850 US (Primary)
Job Type
Full-time
Funding available in current budget
70k+
Exemption Type
Non-Exempt
Career Level
Experienced (Non-Manager)
Education
Bachelor's Degree
Job Description
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.
Job 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
- Experience with bioburden, endotoxin, TOC, and conductivity a plus.
- 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
OTHER REQUIREMENTS: 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.
Travel Expectation
ABL, Inc. participates in E-Verify, an Internet-based system of the Department of Homeland Security (DHS) and Social Security Administration, that allows us to determine an employee's eligibility to work in the United States.
ADDITIONAL INFORMATION:
- Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.
- Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that "negotiable" is neither salary nor requirements. Salary commensurate with experience.
ABL, Inc. does not accept nor respond to unsolicited resumes from vendors, including recruitment agencies and search firms. Approved recruiting agencies must obtain prior approval from ABL, Inc. Human Resources in order to submit resumes to ABL, Inc. for consideration.
Job Tags
Full time, Local area