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QC Microbiologist II

Bedford, Massachusetts, US
Closing date
Dec 12, 2022

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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 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
* Writing validation protocols, perform validation and write validation reports
* Update database for microbiological and validation data
* Performs Internal Audit assignments
* Other duties and projects as assigned

Job 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:


Experience, Knowledge, and Skills Required:

* Requires BS in microbiology, biology or related science
* 2+ 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 assay
* Excellent verbal and written communication skills
* Proven ability to meet deadlines for testing and reporting
* Proficient in the use of Microsoft Office Suite

Desired Experience, Knowledge, and Skills:

* Experience with cGMP, GLP
* Knowledge of FDA regulations and ISO requirements (9001, 13485 and 17025)
* Experience in environmental monitoring of clean room, aseptic media fill evaluation

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