Duties & Responsibilities:

Environmental monitoring, water testing (e.g. TOC, microbial limits), aseptic technique, identification

Microbiological Testing:

Preservative Efficacy (PET/USP <51>), Microbial Limit (MLT/USP <61>/<62>), Bioburden Analysis, USP <60> \"

Microbiological Examination of Nonsterile Products:

Tests for Burkholderia Cepacia Complex (Bcc). Manage environmental monitoring programs for manufacturing and filling lines, reducing particulate and microbial counts. Support plant quality management and gather information from internal and external sources to evaluate the impact of deviations on previously manufactured products and the risk to future operations (Evaluate the impact of deviations on previously manufactured products and the risk to future operations). Provide support during FDA and other regulatory body inspections and customer and internal audits. Perform root cause analysis and proposals for corrective actions. Execute APQRs. Update and maintain quality management systems in compliance with various governing procedures and policies. Assist in the execution of gap analysis and risk assessments to ensure compliance with regulatory requirements. Provide support during FDA and other regulatory body inspections and customer and internal audits. Perform other duties as assigned. Investigate customer complaints and perform root cause analysis and corrective actions. Responsible for supporting PIR management and employee training. Conduct gap and risk assessment analysis to ensure evaluation of key areas in compliance with regulatory requirements. Enhance quality systems to minimize regulatory inspection actions. Make recommendations to management regarding decisions that directly affect consumer health and safety. Comply with procedure driven guidelines. Work in partnership with various departments to assist in problem solving and develop expertise on compliance issues and corporate quality policy requirements. Skills Degree in Microbiology and/or Chemistry. - Required 3-5 Years in a laboratory environment in QC and QA. Special focus on microbiology and environmental monitoring.

Required Quality Assurance:

OOS (Out of Specification) investigations, root-cause analysis, SOP writing, CAPA implementation Must have experience/working knowledge in QC, QA, cGMP, ISO, FDA, EPA, and OSHA matters. Must be detail oriented and meet deadlines while handling multiple tasks. Must have excellent communication skills (verbally and written) . Computer proficient, Excel and Microsoft Word.

Pay:

$75,000.00 - $85,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance

Education:

Bachelor's (Required)

Experience:

Lab and microbiology monitoring: 3 years (Required)

Work Location:

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