PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Ability to articulate work related issues clearly and effectively to management and peers.
• Maintains knowledge of cGMPs and GLPs. Maintains knowledge of current compendial methods.
• Ensures safety related polices are adhered and makes recommendations to enhance or improve safety policies. Ensure DEA policies related to controlled drugs are adhered to.
• Handling of laboratory instruments such as sterilizers, isolators, total organic carbon analyzer, bacterial endotoxin analyzer.
• Performs other duties as assigned.

Environmental Monitoring

• Performs routine and non-routine environmental monitoring according to established procedures.
• Assesses environmental conditions using various methods to sample environment, water systems, compressed gas, and personnel in production areas and microbiology laboratory. Recognizes out of limit results and initiates OOL investigations.
• Must successfully execute requirements to achieve classified areas gowning certification.
• Processes paperwork, LIMS input and approvals for release by QA Critical Systems.

Finished Products Testing

• Performs routine testing of in-process, finished product, raw material.
• Conduct environmental monitoring during bioburden testing and sterility testing.
• Completes activities required for microbial identification including sub-culture, Gram staining, proper culture maintenance and processing for outside laboratory identification.
• Maintains testing equipment and coordinates requalification, preventative maintenance and calibration as needed.

REQUIREMENTS

• BS/BA degree in science or related field.
• -Or-
• AS/AA degree with 1-2 years of relevant laboratory experience.
• Working knowledge of cGMPs and GLPs.
• Excellent verbal and written communication skills are essential. Strong attention to details, people skills and ability to multi-task are essential for success.

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