At minimum, the role is responsible for reviewing environmental monitoring data, providing support for batch disposition, assist in maintaining facility control, generating appropriate reports, leading quality control deviations/investigations, organizing/implementing appropriate processes and conducting all environmental monitoring validations.
Roles and Responsibilities:
• Conduct routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility. • Incubation and enumeration of samples related to environmental monitoring processes. • Conduct morphology assessment on appropriate samples at the conclusion of the incubation term. • Draft and monitor all procedures as they relate to quality control microbiology and internal laboratory testing. • Maintain and review all environmental monitoring records. • Organize, draft, and monitor all protocols associated with the environmental monitoring program. • Serves as subject matter expert in audit situations as it relates to microbiology/environmental monitoring. • Continuous improvement of environmental monitoring program. • Perform environmental monitoring risk assessment of new and existing processes at STAQ facility. • Organize, monitor, and assist with all production/routine environmental monitoring performance. • Provide quality control and microbiology support to operations. • Collect, submit, ship, and manage appropriate raw material, microbiological and finished goods samples to third party testing laboratories. • Provide guidance and changes in scheduled cleaning of facility based on shutdown activities and environmental monitoring trending. • Assist in the review of completed cleaning records. • Organize, manage, review and trend all environmental monitoring data. • Provide trending reports to upper management. • Lead and draft investigations as they relate to environmental monitoring or quality control deviations. • Implementing CAPA’s as they relate to routine and production environmental monitoring deviations. • Solve process, procedural, equipment issues via experimentation or revision of procedures. • Other duties as assigned.
Qualifications and Education Requirements:
• B.S. or B.A. in Microbiology or a closely related field / or equivalent experience • Experience with cGMP aseptic manufacturing environment. • Minimum five (5) to ten (10) years’ experience in a sterile, cGMP, and quality control environment.
• Preferred previous pharmaceutical experience. • Familiarity with 21 CFR Part 11/210/211
Apply online (i.e., indeed, zip recruiter) where advertised or send to email@example.com.
Also, the job is in Denver, CO (Montebello area) and pay is $60,000 – $80,000 a year. Thanks.