QC Microbiologist II

Advanced BioScience Laboratories; Rockville, Northern (MD, KY); Hybrid; USD 63,000 - 77,000; Full time

Job summary

ABL, Inc. in Rockville, MD is seeking a QC Microbiologist II to support environmental monitoring and QC testing for biopharmaceuticals in a GMP facility. The role involves data entry, trend analysis, and collaboration on investigations and CAPAs.

Requirements include a Bachelor's degree in microbiology or related field and at least 3 years in a GMP QC lab, with strong communication and documentation skills. The position is full-time and on-site.

Qualifications

• Bachelor's degree in microbiology, biology or related field.
• Minimum 3 years of experience with biological products in a GMP QC lab.
• Experience performing environmental monitoring and testing.

Responsibilities

• Perform environmental monitoring for HVAC, viable air/surface, and particulates.
• Enter data into EM database and assist trend reports.
• Participate in visual inspection program of final products.
• Log samples, assign accession numbers, and coordinate shipments to labs.
• Perform microbiological testing (bioburden, endotoxin, growth promotion).
• Support quality records, investigations, deviations, and CAPAs.
• Assist labeling, packaging, and raw material release activities.
• Maintain reagents and supplies and ensure procedures are followed.

Skills

Environmental monitoring

Purified water sampling

Bioburden testing

Endotoxin testing

TOC testing

Conductivity testing

cGMP experience

CAPA processes

OOS investigations

Deviations management

Change control

Quality systems

Documentation

Communication skills

Teamwork

Independent work

Interpersonal skills

Proactivity

Pressure management

Education

Bachelor's degree in microbiology, biology or related scientific field

Tools

MS Office Suite

Job description

QC Microbiologist II - (00326_COMPANY_1.7)

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

Job Type

Full-time

Funding available in current budget

70k+

Exemption Type

Non-Exempt

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 3years' related experience with biological productsin 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.

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.

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.