Randstad Microbiologist in Norwood, Massachusetts
salary:$34.82 - $40.87 per hour
date posted:Thursday, June 14, 2018
Job Title: Senior Associate, QC Microbiology
Reporting to the Senior Manager of Quality Control (Microbiology), the Quality Control Microbiology Senior Associate will support microbiological method transfer, qualification and release testing for GMP QC raw materials, excipients, drug substance and finished product testing for mRNA products produced at te company's manufacturing facility and affiliated contract organizations.
He/she will contribute to the implementation of QC Microbiology testing capabilities, related method transfers and qualification activities, investigations and assay/instrument troubleshooting.
This position will have a primary focus in supporting Quality Control testing in association with the Company's Personal Vaccine Unit (PVU).
The position may require off-shift hours including nights and weekend.
Collaborate with development groups for method transfers and qualifications in support of expanding the GMP QC Microbiology laboratory capabilities to include: Rapid Sterility, Rapid Bioburden, Endotoxin, Culture Purity and Cell Stock Identity, Cell Density Determination, TOC and Conductivity Testing utilizing both standard and rapid methods.
Support testing for raw materials, intermediates, drug substance and drug product, including generation of testing data to support clinical studies
Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
Assist with equipment qualification / validation activities, including maintenance
Troubleshoot issues related to equipment, laboratory procedures and assay performance
Conduct technical assessments of deviations and investigations
Write/revise SOPs, technical protocols and reports
Offer input and suggestions for improvement in laboratory operations and procedures
Train and provide technical guidance to other microbiologists
Education & Qualifications
BS in a relevant scientific discipline with a minimum of 2-5 years (or MS in a relevant scientific discipline with 0-2 years) Quality Control experience in a cGMP organization with a focus in Microbiology
Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
Expertise with Vitek®, MicroSEQ® Rapid Identification Systems, Rapid Microbiology Systems and Isolator Technology
Demonstrated knowledge of method development and qualifications
Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
Ability to collaborate effectively in a dynamic, cross-functional matrix environment
Excellent communication skills (verbal and written)
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.