West Chester, PA Contract Duration: 3-36 months Rate: Negotiable Salary: NA $1.00 Responsibilities: Excellent employment opportunity for a Microbiologist in the West Chester, PA area. Prepare documentation of activities, actions, and/or results. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation. Complete required training. Ensure proper documentation practices during job activities. Perform visual inspections. Verify count, measure and check materials to ensure proper components, quantities, and/or characteristics. Train others on systems, software, equipment, machines, procedures, and/or processes. Answer compliance and process questions from others. Communicate policies and procedures to employees. Establish visual tracking and other tools to enhance Audit readiness and trend analysis. Gather, organize, and communicate operational information to others. Lead and coordinate investigations and studies with little supervision. Communicate priorities and progress to team on a continuing basis. Ensure that employees have the tools needed to perform their jobs. Facilitate communication between management and non-management. Facilitate team meetings to discuss progress, initiatives, and/or other matters. Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Investigate deviations. Lead training on all document modifications prior to effective date. Provide leadership, development, and mentoring for others. Assist with coordinating activities of support groups. Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements. Close out deviations, CAPAs, and/or pAFCAs as needed. Monitor records to ensure compliance with regulatory requirements. Monitor training of employees to ensure compliance. Monitor equipment and/or systems for performance and problem indicators. Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities. Check batch records for accuracy and communicate any issues to necessary parties. Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area. Ensure that others carry out laboratory duties in a manner consistent with cGMP. Use MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics. Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product. Lead change control activities. Performing high purity water testing. Provide "off shift" support (for example: night shift support if you normally workday shift). Provide 24/7 "on-call" support to others. Shift: As it stands, this would be standard Monday - Friday role. But we need candidates to flexible as business/project needs can change quickly. Experience: Bachelor's Degree in Biology, Microbiology or related discipline and 3 years of experience in a regulated or cGMP environment. 2 years of experience supporting Microbiological testing in a sterile Pharmaceutical operations environment. An eye exam is required as part of the onboarding process for this role. Must pass an intermediate and near visual acuity of 20/20 or better and successfully complete color blindness testing (i.e., Farnsworth-Despisteo machine and Ishihara Plates 17/21). Tasks related to the quality of Pharmaceutical products in the Microbiology Department.
Job Title
Microbiologist