DifGen Pharmaceuticals

QC Microbiologist I

DifGen Pharmaceuticals  •  Tamarac, FL (Onsite)  •  20 days ago
Apply
AI can make mistakes so check important info. Chat history is never stored.
25
AI Success™

Job Description

Job Location: Tamarac, FL 33321
Job Shift: AnyAbout 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

QualificationsEducation
-  Bachelor's degree (B. S.) in microbiology or equivalent
Knowledge, Skills and Abilities
- FDA, cGMPs, and SOPs related to job requirements.
Experience
- Minimum of 1-2 years laboratory experience.
- Master's degree (M.S) in microbiology and a minimum of 1-2 years laboratory experience.
Benefits:
- 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
Equal Opportunity Employer
DifGen Pharmaceuticals

About DifGen Pharmaceuticals

We are a US based Global Pharmaceutical company with a primary focus on developing complex high barrier to entry Generics and Specialty Pharmaceutical products that would help increase accessibility to high quality medication thereby leading to the creation of next generation healthy communities. We are driven by an earnest pursuit of redefining the accepted standards in pharmaceutical product development and commercialization. We consistently aspire to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. Our talented team with some of the brightest minds have developed a holistic understanding of the nuances associated with the development of unique, commercially viable and difficult product lines across varying therapeutic areas and a broad array of dosage forms such as Injectables, Ophthalmics, Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Hyderabad, IN
Year Founded
Unknown
Social Media