Quality Control (QC) Environmental Monitoring (EM) Specialist

Responsibilities

• Execute analytical and microbiological testing on in-process materials and finished vaccine products, including (but not limited to): Growth media growth promotion, microbial seed viability, microbial identification, Gram Stain, protein concentration, visual inspection.
• Routine tasks: Environmental monitoring of production clean rooms, sampling and testing the in-house purified water, WFI, and clean steam, sampling and testing of the in-house compressed gas system.
• Assist senior associates on lab projects as requested and work on specialty projects as assigned.
• Order supplies and perform basic laboratory equipment care.
• Participate in SOP revision or authoring of new SOPs as required.
• Provide all job-related progress reports or technical reports, as requested, in a timely manner.
• Maintain a safe workplace, ensuring that they know and observe appropriate safety and occupational health rules and regulations.
• Attend safety training relative to their position and report any infractions of safety procedures to the facility Safety Officer.
• Perform other duties as assigned.

Qualifications

• BA/BS degree in a science field (preferably chemistry, biochemistry, biology, microbiology, or engineering) and four years of experience in a regulated laboratory environment or an equivalent combination of credentials and experience.

Skills

• Inspite of the preference for analytical techniques and laboratory equipment, skills in using various types of analytical techniques and laboratory equipment are preferred.
• Excellent computer skills, including Microsoft Office software such as Word and Excel.
• Experience with technical writing and LIMS is a plus.
• Knowledge of aseptic technique, cGMP, cGLP, or FDA regulations a plus.