QC Microbiologist II
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AVEVA DRUG DELIVERY SYSTEMS INC
FL
Summary
The QC Microbiologist II performs microbiological testing on raw materials and finished products while maintaining a GMP-compliant laboratory environment. Responsibilities include bio-burden monitoring, water system testing, and the authoring of technical protocols and reports.
Job Description
Job DetailsJob Location: Tamarac, FL 33321Job Summary:
The QC Microbiologist II performs microbiological testing of raw materials, intermediate/finished products, and environmental bio-burden. He/She maintains a functional and current GMP compliant microbiology laboratory.
Job Responsibilities
• Perform Microbial Limits and Microbial Limits Validation assay of finished products, raw materials, and components in a timely manner.
• Perform bio-burden monitoring of the manufacturing facility and the microbiology laboratory.
• Review current USP and the regulatory guidance to ensure compliance with current microbiological methods and practices.
• Responsible for daily monitoring and testing of the USP Purified Water System.
• Author, and review of microbiology Protocols, Reports, STP's and SOP's.
• Responsible for microbiology testing for weekend and holiday schedules, as needed.
• Performs trend analysis of microbiology test results from products, water system, bio-burden and author reports.
• Perform IQ/OQ/PQ on instruments and author the protocols/reports.
• Attend seminars on special topics to continually evaluate improvements to the microbiology laboratory, testing, and policy.
• Required to participate in audits and/or consultations with other departments, as required.
• General procurement assignments and responsibilities for the microbiology laboratory: monitor housekeeping, bio hazard waste disposal, sample discard, discard of expired reagents, media preparation, sterilization of waste and glassware, instrument calibration/maintenance/daily monitoring, quarterly expenses report, and inventory/ordering.
• Works as a member of a team to achieve all outcomes
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
• All other relevant duties as assigned
QualificationsJob Requirements
• Education
o Bachelor's degree (B. S.) in microbiology or equivalent
• Knowledge, Skills and Abilities
o FDA, cGMPs, and SOPs related to job requirements.
• Experience
o Minimum of 2-4 years laboratory experience.
o Master's degree (M.S) in microbiology and a minimum of 1-2 years laboratory experience.
AVEVA is a global leader in transdermal drug delivery located in the United States. The company has an extensive history of providing pharmaceutical partners with fully integrated, controlled-release transdermal products that fulfill unmet market needs or supply high-quality, affordable brand equivalents. By leveraging this experience, AVEVA offers a full range of research, development and manufacturing capabilities to produce transdermal pharmaceutical products that can improve the quality of life, usage and compliance rates for patients.
Founded
2003
Company size
201-500 employees
Industry
Pharmaceutical Manufacturing
Org type
Privately Held
Headquarters
Miramar, FL
AVEVA is a global leader in transdermal drug delivery located in the United States. The company has an extensive history of providing pharmaceutical partners with fully integrated, controlled-release transdermal products that fulfill unmet market needs or supply high-quality, affordable brand equivalents. By leveraging this experience, AVEVA offers a full range of research, development and manufacturing capabilities to produce transdermal pharmaceutical products that can improve the quality of life, usage and compliance rates for patients.
Founded
2003
Company size
201-500 employees
Industry
Pharmaceutical Manufacturing
Org type
Privately Held
Headquarters
Miramar, FL