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