QC Microbiologist II

Company: Anika Therapeutics
Location: Bedford
Posted on: January 27, 2023

Job Description:

Position Scope:Responsible for 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.)Strategic Focus Area:Effectively collaborates with internal colleagues to meet corporate objectives and drive business results. Demonstrates business and regulatory knowledge.Specific Responsibilities:Perform bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samplesPerform company's purified water and DI water bioburden, endotoxin and TOC testing as per USP requirementsComplete all required documentation according to SOPWriting validation protocols, perform validation and write validation reportsUpdate database for microbiological and validation dataPerforms Internal Audit assignmentsOther duties and projects as assignedJob Complexity:Assignments are defined by objective and required outcome. Exercises judgment within defined parameters and policies; expected to complete routine assignments with minimal supervision. Supervisory Responsibilities None.Experience, Knowledge, and Skills Required:Requires BS in microbiology, biology or related science2+ 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, bacteriostasis and growth promotion assayExcellent verbal and written communication skillsProven ability to meet deadlines for testing and reportingProficient in the use of Microsoft Office Suite Desired Experience, Knowledge, and Skills:Experience with cGMP, GLPKnowledge of FDA regulations and ISO requirements (9001, 13485 and 17025) Experience in environmental monitoring of clean room, aseptic media fill evaluation

Keywords: Anika Therapeutics, Boston , QC Microbiologist II, Other , Bedford, Massachusetts