- Key Responsibilities:
• Working knowledge in cGMP and other regulations in order to assure laboratory compliance.
• Report Observations. Revise SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines.
• Send Labortory equipment out for calibration. Review/approve equipment.
• Initiate and resolves quality investigations for excursions relating to routine laboratory testing and equipment calibrations. Supports Change Controls and CAPAs
• Perform routine testing ,documents and reports results while following validated procedures for raw materials, in process samples, utilities / environmental monitoring and validation testing under the assigned direction of the supervior or designee.
• Complete verification for environmental monitoring,Inprocess samples and utilities.
• Assist with the execution of validation protocols and reports.
• Routinely utilize SAP/MERPs Trackwise and CMX for data entry.
• Complete monthly work orders
• Supports regulatory audits as needed
Knowledge/ Education / Previous Experience Required:
• B.S. degree in a science field required in Biology, Microbiology or other related science field
• Entry level candidates acceptable
• Good communication skills
• Works well in a team environment as well as ability to work independently.
• Make sound compliant decisions when needed.
• Experience with Excel, Word
• Flexible work schedule
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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