What are the responsibilities and job description for the QC Microbiologist I position at Aveva Drug Delivery Systems?
Description
About Us:
Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.
Job Summary
The QC Microbiologist I performs microbiological testing of DI water, intermediate/finished products, and environmental bio-burden. He/She maintains a functional and current GMP compliant microbiology laboratory.
Key Responsibilities
Education
About Us:
Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.
Job Summary
The QC Microbiologist I performs microbiological testing of DI water, intermediate/finished products, and environmental bio-burden. He/She maintains a functional and current GMP compliant microbiology laboratory.
Key Responsibilities
- Perform Microbial Limits Testing on finished products, and raw materials 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.
- Support microbiology testing for weekend and holiday schedules, as needed.
- 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.
- 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
Education
- Bachelor's degree (B. S.) in microbiology or equivalent
- FDA, cGMPs, and SOPs related to job requirements.
- Minimum of 1-2 years laboratory experience.
- Master's degree (M.S) in microbiology and a minimum of 1-2 years laboratory experience.
- Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan
- Medical/Dental/Vision Insurance
- Paid Time Off
- 401k with employer match
- Paid Holidays and Floating Holiday