QC Microbiologist

Job Description

QC Microbiologist I

Location: Tampa, FL
Industry: Pharmaceutical
Hours: M-F, 8am-5pm with possible OT and/or weekends
Hourly Rate: $31/hr.-$34/hr. based on experience
Employment Type: Contract position

Summary:
The Quality Control (QC) Microbiologist I is responsible for performing microbiological testing of raw materials, utilities, in-process samples, water sampling/testing, finished products, and environmental monitoring samples to ensure compliance with regulatory requirements, company procedures, and quality standards. Perform microorganism identification. Perform growth promotion and sterility testing of media. This role supports manufacturing operations by providing accurate and timely microbiological data, investigating deviations, and contributing to continuous improvement initiatives
Key Accountabilities:

• Performs, analyzes, and interprets QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples.
• Perform environmental monitoring, which includes water sampling and testing.
• Perform microbiology methods and sampling techniques.
• Perform microorganism identification.
• Report, investigate, and write deviations and investigations.
• Receive media. Perform growth promotion and sterility testing.
• Manages/supports microbiology projects.
• Execute validation protocols for test methods and equipment qualification.
• Provide support during audits.
• Review SOPs and test methods related to microbiology.
• Ensure the microbiological integrity of the environment, equipment, and facilities.
• Manage product testing based upon internal and customer specifications.
• Manage 3rd party laboratory testing and report results.
• Reports on testing results, including CoA s.
• Maintain equipment and media.
• Ensure the micro lab is adequately supplied and maintained.
• Perform other responsibilities to support the business as requested.
• Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear.
• Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible.
• Adhere to current Good Manufacturing Practices (cGMP), FDA, EMA, USP, and other applicable regulatory requirements
• Trend environmental monitoring and utility data and identify potential issues.
• Recommend process improvements to enhance laboratory efficiency and compliance.
• Stop work where deemed necessary to maintain safety.
• Must be able to travel between local worksites in Tampa during the workday, as needed.

Qualifications:
Education and Experience:

• Minimum of associate s degree in scientific discipline (Microbiology, Biological Sciences, Biology), Bachelors Degree highly preferred
• Minimum of three years of pharmaceutical or relevant FDA/GMP regulated environment

Technical Skills

• Knowledge of microbiological techniques and aseptic practices.
• Familiarity with USP <60> , <61> , and <62> , and environmental monitoring programs.
• Experience with laboratory systems such as LIMS and electronic quality management systems.
• Understanding of cGMP requirements and microbiological investigations.
• Experience with data tools (Microsoft Office)

Competencies

• Attention to detail
• Analytical and problem-solving skills
• Strong written and verbal communication
• Time management and prioritization
• Ability to work independently and within cross-functional teams
• Data analysis and trending capabilities

Working Conditions

• Laboratory and manufacturing environment.
• May require weekend, holiday, or 12-hour shift coverage.
• Use of personal protective equipment (PPE) and adherence to safety procedures required.

Success Metrics

• Timely completion of microbiological testing.
• Accuracy and integrity of laboratory data.
• Compliance with GMP and regulatory requirements.
• Effective investigation and resolution of laboratory deviations.
• Support of manufacturing schedules and product release timelines.

EOE/ADA