QC Analyst IV/V (Microbiology)
SRG Life Sciences is in need of a QC Analyst IV/V (Microbiology) for our priority client! Reach out to me if you or someone you know has interest!
Framingham, MA 6-12 months &
open to Temp to perm
QC Analyst IV/V (Microbiology)
This function plays a key role in quality control activities and performs general laboratory procedures in support of microbiological testing.
Data analysis, trending, and reporting using MS Word and Excel.
• Conducts microbiology routine and non-routine testing per approved SOPs. This includes analysis of raw materials, in process and finished formulations, microbial identifications, environmental monitoring and water collection/testing including but not limited to Bioburden, Endotoxin, and TOC.
• Involved in activities regarding development of assays methods for use in QC lab and will participate in validation studies, assay qualifications and special projects as assigned.
• Will author validation and qualification studies and associated reports
• Proficient in writing quality systems records (Deviations, Change Controls, CAPA)
• Troubleshoots assay methods and equipment with minimal assistance of management and assists in troubleshooting and investigations for Alert/Actions, OOS and other non-conforming results.
• Generates and documents laboratory data and performs peer reviews of data as needed.
• Responsible maintenance and calibration of lab equipment and support of general laboratory functions including monitoring equipment, calibration status, reagents and expiration status, general cleanliness.
• Proficient in performing aseptic technique for critical biological assays.
• Participates in audits and act as technical SME.
• Primary designee to represent QC Microbiology with QC management as appropriate.
• Understands and follows microbiology compendia methods, cGMPs, GLPs, SOPs, USP and FDA guidelines in all appropriate functions and notifies management of observed discrepancies in laboratory. Lead the investigation of those discrepancies with minimal oversight by management
• Will author design protocols, change control requests, and Quality Technical Reports, as directed
• Identifies, leads investigation and reports deviations to supervisor and follows established corrective actions or suggests procedures for improvements.
Previous Experience: 6+ years related work experience within a cGMP laboratory.
Skills: Microbiological or bio-analytical techniques, general laboratory skills, computer skills. Working experience of microbiological methodologies such as Environmental monitoring, bioburden and endotoxin testing. GMP QC environment experience is required. Experience in authoring, SOPs protocols and technical reports.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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