Summary of Primary Responsibilities:
Responsible for all microbiological and some analytical testing of production materials under GMP conditions. Responsible for process and equipment validation (autoclave and depyrognenation oven) in cooperation with Engineering and R&D (New Product Sterility and LAL validation.)
- Perform bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samples
- Perform company’s purified water and DI water bioburden, endotoxin and TOC testing as per USP requirements
- Complete all required documentation according to SOP
- Verify work of technicians and assists in training
- Review environmental condition of classified areas, maintain database for environmental results of clean room environment and summarize data for annual environmental report
- Provide training on environmental compliance issues
- Development and validation of new or improved microbiological methods
- Writing and/or approving validation protocols, coordinating and/or performing validation and writing and/or approving validation reports
- Establishing databases for microbiological and validation data
- Performs Internal Audits as scheduled
- Other duties and projects as assigned
Works on complex problems requiring in-depth analysis and evaluations of factors, and on assignments that are required to be performed according to defined procedures and practices. Exercises considerable judgment and intiative within broadly defined practices and policies in selecting methods and techniques. Normally receives no instruction on routine work, general instructions on new assignments.
Experience, Knowledge, and Skills:
- Requires BS in microbiology, biology or related science or equivalent experience.
- 1+ years experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP (membrane filtration, endotoxin and TOC), bacteriostasis and growth promotion assay
- Experience with GMP, GLP, and FDA regulations and ISO requirements
- Experience in environmental monitoring of clean room, aseptic media fill evaluation
- Excellent verbal and written communication skills
- Proven ability to meet deadlines for testing and reporting
- Proficient in the use of Microsoft Office Suite including PowerPoint
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.