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Quality Control Analyst II

Company Name:
Makro Scientific
This individual will report to the QC shift Supervisor in the Allston Quality Control laboratory and
will contribute to general operations and testing of the QC Microbiology laboratory. QC Analyst
II works independently with minimal supervision. Primary responsibilities include, but are not
limited to the following: collect and process samples in a timely manner, microbiological routine
testing of raw materials, in-process, validation samples and final products in accordance with
SOPs and CGMP regulations, review laboratory assay documentation for accuracy and
timeliness, participate with the team to meet group goals and perform routine laboratory duties.
Skills -Perform Water, Steam and Critical Utility collection as well as associated testing
-Perform Biological Indicator Testing
-Perform Environmental Monitoring
-Perform Endotoxin Testing (LAL Gel-Clot and Kinetic Turbidimetric)
-Perform Bioburden Testing of In-process products, buffers, and water
-Receipt of manufacturing samples into the QC lab as well as sample retain disposal
-Autoclave QC micro equipment
-Troubleshoot assay and instrument problems with Laboratory Supervisor
-Enter and review data in LIMS
-Perform safety and operational lab audit
-General maintenance of Lab equipment
-Participate in writing and revising SOPs, protocols
-Assist in the development and optimization of testing methods
-Maintain log books related to inventory and equipment
-Ensure labs are clean and safe (in compliance with CGMP) and properly stocked
-Make detailed observations in support of Alert, Action and OOS result investigations
-Participate in the qualification of equipment, methods, and processes
-Participate and perform special studies & projects assigned to microbiology
-Perform Sterility Testing
-Perform Growth Promotion Testing
-Perform Plate Reading
-Conduct data analysis based on sample specification
-Perform safety and operational lab audit
-General maintenance of Lab equipment
-Performing routine QC testing of in-process and final products in a CGMP lab for release.
-ELISA testing, container closure testing, particulate testing, HACH, and plate streaking.
-Provide training and technical leadership to less experienced staff.
-Participate in authoring complex and explicit documentation (Protocols and technical
reports).
-Involvement in equipment qualification (IQ, OQ, and PQs) and method validation.
Keywords
Education -Bachelor's and in Life Sciences discipline and 2 years experience in CGMP lab environment
OR
-Master's Degree in Life Sciences discipline and 1 year experience in CGMP lab Environment
-Proficient in Outlook and MS Word and Excel and lab based data management systems
If you are interested send your updated resume along with below details.
Full Name:
Expected Pay Rate:
DOB:
Availability:
Visa status:
Address:
Thanks & Regards
Khadeer Khan Clinical & Scientific Recruitment Specialist
Email:
Phone: 973-481-0100 Ext 3079
www.linkedin.com/in/khadeermohmmed

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