Microbiologist

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.

• 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.