This job has expired

QC Microbiologist

Employer
Actalent
Location
Bedford, Massachusetts, US
Salary
Competitive
Closing date
May 20, 2022

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
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If interested in joining a rapidly growing organization within the biotech space, please send your resume to marcmill@actalentservices.com

Description:

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.)

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

• 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

Additional Skills & Qualifications:

Experience, Knowledge, and Skills Required:

• Requires BS in microbiology, biology or related science

• More than 5 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

About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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