QC Microbiologist I Position Available In Middlesex, Massachusetts

Job Description:

Responsible for all microbiological and some analytical testingof production materials under GMP conditions. Responsible forprocess and equipment validation (autoclave and depyrognenationoven) in cooperation with Engineering and R D (New ProductSterility and LAL validation.)

Specific Responsibilities:

• Performbioburden, sterility and endotoxin testing of raw materials,in-process samples, bulk and finished products and stabilitysamples
• Perform company’s purified water and DI water bioburden,endotoxin and TOC testing as per USP requirements
• Complete allrequired documentation according to SOP
• Verify work oftechnicians and assists in training
• Review environmentalcondition of classified areas, maintain database for environmentalresults of clean room environment and summarize data for annualenvironmental report
• Provide training on environmental complianceissues
• Development and validation of new or improvedmicrobiological methods
• Writing and/or approving validationprotocols, coordinating and/or performing validation and writingand/or approving validation reports
• Establishing databases formicrobiological and validation data
• Performs Internal Audits asscheduled
• Other duties and projects as assigned

Job Complexity:

Works on complex problems requiring in-depth analysis andevaluations of factors, and on assignments that are required to beperformed according to defined procedures and practices. Exercisesconsiderable judgment and initiative within broadly definedpractices and policies in selecting methods and techniques.

Normally receives no instruction on routine work, generalinstructions on new assignments.

Experience, Knowledge, and Skills:

• Requires BS in microbiology, biology or related science orequivalent experience.
• 1 years experience in pharmaceuticalindustry with microbiological testing such as sterility/bioburden,new product validation, LAL testing and validation, microbialidentification, gram staining, purified water testing as per USP(membrane filtration, endotoxin and TOC), bacteriostasis and growthpromotion assay
• Experience with GMP, GLP, and FDA regulations andISO requirements
• Experience in environmental monitoring of cleanroom, aseptic media fill evaluation
• Excellent verbal and writtencommunication skills
• Proven ability to meet deadlines for testingand reporting
• Proficient in the use of Microsoft Office Suiteincluding PowerPoint