QC Microbiology

Job Description

Pharmaceutics International, Inc. (Pii), a Jabil company, has an exciting opportunity for an experienced Quality Control (QC) Microbiologist to join our pharmaceutical team in Hunt Valley, MD!

Pii provides CDMO solutions specializing in aseptic manufacturing, oral dosage forms, and accelerated drug development. Together, Jabil and Pii offer truly end-to-end pharmaceutical solutions.

Shift: 3rd Shift Sun-Thur 11p-7:30a overtime as needed including weekends

Local Candidates Preferred

Pay Rate $30-35/hr DOE 15% shift differential

Multiple openings available

How will you make an impact?

The QC Microbiologist will play a critical role in ensuring the microbiological quality and compliance of raw materials, in-process samples, finished products, and the manufacturing environment in accordance with cGMP and regulatory standards.

What will you do?

• Provides QC microbiology support to the Aseptic Manufacturing and validation process.
• Performs Microbiological Tests and studies by following the established procedures referenced in the official sources.
• Collection of water samples for testing (WFI, DI, Raw)
• Collection of samples (Raw Materials, Excipients, Validation, In-process and Finished product samples) for microbiological/chemical testing.
• Conducts validations studies and routine tests related to Bioburden Tests, Bacterial Endotoxin Tests, Particulate Matter Test, and Sterility Tests.
• Preparation of microbiological media and diluents by following laboratory procedures.
• Quality Control Testing of microbiological media and reagents.
• Environment Monitoring of Aseptic / Non-aseptic Manufacturing areas and Trending of microbial data obtained from EM/Utilities/Raw Materials/In-process and finished products testing and preparing the periodical summary report.
• Maintenance of Laboratory inventory and cleanliness of the Laboratory.
• Responsible for maintaining the microbiology isolates obtained from EM and Utility Monitoring Program.
• Follow established health and safety procedures and policies related to QC Microbiology Laboratory operations. Perform other related duties as required and assigned by Microbiology Laboratory Management.
• Perform other duties as assigned.
  
  

How will you get here?

Education and Experience:

• High School or equivalent required. Associate’s or Bachelor’s degree in Microbiology, other related life science preferred.
• 1-3 years of relevant experience working in cGMP cleanroom and QC microbiology or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Experience in a Pharmaceutical manufacturing environment desired
• Must be comfortable with varying levels of aseptic techniques
• Strong understanding of cGMP, USP, EP, and regulatory requirements for microbiological testing.
• Familiarity with rapid microbiological methods and modern instrumentation (e.g., endotoxin testing systems, automated identification systems).
  
  

Knowledge, Skills, Abilities:

• Excellent attention to detail and documentation practices
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate ability to acquire the appropriate knowledge from resources on electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate the ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate literacy and ability to use data acquisition and processing software.
• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Strong written and verbal communication skills with legible handwriting.
  
  

, BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in., The hourly pay range for this role is $22.84 - $41.11. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity., As part of the total rewards package, Jabil offers benefits to enhance your health, wealth, and resilient self. These include medical, dental, and vision insurance plans; paid time off; paid parental leave; company-paid holidays subject to change yearly; 401(k) retirement plan; and employee stock purchase plan.