Microbiologist

west chester, Ohio

Our client is seeking a Microbiologist to join their team in West Chester, Ohio for a 6+ month contract.

This role will be a weekday (Monday – Friday) shift, but our client needs candidates to be flexible as business/project needs can change quickly.

Within this role, you will perform tasks related to the quality of pharmaceutical products in the Microbiology Department.

Qualifications

Physical Requirements:

  • 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)

Required

  • 4-year degree in Biology, Microbiology or related discipline and 3 years of experience in a regulated or cGMP environment.

Preferred

  • 2 years of experience supporting microbiological testing in a sterile pharmaceutical operations environment

Responsibilities

  • 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.
  • Conduct troubleshooting activities.
  • 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.
  • Identify temporary and permanent fixes to address issues.
  • Monitor records to ensure compliance with regulatory requirements.
  • Monitor training of employees to ensure compliance.
  • Coordinate with representatives from other departments.
  • Alert others (for example: supervisor, manager) when problems occur outside of SOPs (Standard Operating Procedures).
  • Attend team meetings to discuss progress, initiatives, and/or other matters.
  • Collect, record, and report metrics.
  • Monitor equipment and/or systems for performance and problem indicators.
  • Perform data entry.
  • 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.
  • Ensure that outgoing product is reviewed, documented, and releasable.
  • Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).
  • Maintain archived records and documentation.
  • Perform logbook reviews.
  • Provide feedback on service and quality issues on a timely basis.
  • Review and approve quality documentation.
  • Serve as SME (subject matter expert) for aseptic operations.

Other Duties

  • Fill in for immediate supervisor when absent.
  • Lead process improvement activities and teams to meet strategic goals.
  • Use MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics.
  • Develop lean processes and procedures.
  • Interact with regulatory agency personnel during audits and inspections.
  • Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
  • Review and approve documentation needed for qualification of equipment and processes.
  • Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
  • Write, review, and revise SOPs (Standard Operating Procedures) for maintenance of equipment, systems, and/or facilities.
  • Author, review, and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
  • Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
  • Facilitate inter-departmental meetings to discuss matters involving the coordination of multiple departments.
  • Interact with other departments to implement corrective/preventative actions.
  • Participate in cross-functional teams to meet strategic goals.
  • Review and approve OCMs, change controls, and document revisions.
  • Provide "off shift" support (for example: night shift support if you normally work day shift).
  • Assess and implement improvements in productivity, waste generation, quality and cost.
  • Assign work tasks and activities to others.
  • Lead committees or groups of employees tasked with accomplishing some objective(s).
  • Coordinate qualification activities.
  • Lead change control activities.
  • Lead teams in root cause analysis sessions.
  • Perform routine sampling activities.
  • Performing high purity water testing.
  • Provide 24/7 "on-call" support to others.
  • Recommend compliance resolutions to management.

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