QC Microbiologist I/II

Job Title:  QC Microbiologist I/II

 

Department:  Quality Control

 

*Position may include alternating work days, including weekends.

 

Summary:  Microbiological testing for release of product including microbial limits and sterility testing. Testing raw materials and in process samples, enumeration and interpretation of environmental isolates, and other related procedures including but not limited to environmental monitoring and growth promotion. May be required to perform validation, technology transfer, preparation of process and status reports and writing new microbiology reports and procedures as needed. The QC Microbiologist I/II is responsible for complying with Good Manufacturing Practices.

 

Essential Duties and Responsibilities include, but not limited to: Perform routine and non-routine testing of raw materials, packaging components, bulk and finished products according to established written procedures.Conducts data review for compliance to specifications.Assists in methods validation planning and execution including writing reports. Stability testingRevises SOP’s and all Quality Control Procedures as needed.Provide lab support of general QC laboratory activities such as equipment maintenance, ordering of lab supplies including media and other microbiology reagents.Issuance of logbooks.Maintain QC laboratory, premises and equipment.Issues batch records as needed.Perform other duties as specified by Quality Control Management. 

Requirements/Skills:Experience in GMP required.Familiarly with microbiology procedures as outlined in current USP desired.

Education: PHD/MS/BS/AS and preferred type of degree: BS and preferred type of degree in Microbiology/Biology.

Experience Level (Years): 3+ years of relevant experience.

AMAG Pharmaceuticals is a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. AMAG Pharmaceuticals is an Equal Opportunity Employer.