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Mount Vernon, IN

Posted: 01/25/2023 Job Number: 22948105

Job Description

*2 years laboratory experience.
** High level of knowledge and competence with laboratory equipment, or a QC/QA process or system.

Required Skills:
  • Bachelor's degree or a minimum of 3 years of demonstrated relevant experience in Quality Control lab setting; Bachelor of Science degree, preferably in Microbiology or a related discipline.
  • 2 years of laboratory experience.
  • High level of knowledge and competence with a specific piece of laboratory equipment, or a QC/QA process or system.

Project Description:
  • Responsible for routine microbial testing on product, utilities, environmental monitoring of GMP areas and review according to policy and procedures at consistently high levels with a focus on quality and efficiency (Role may include shift work).
  • Performs data review activities as required.
  • Participates in and may lead some QC Team Discussions.
  • Maintains adequate inventories of reagents, glassware, and other supplies.
  • Maintains current, complete, legible notebooks and laboratory records in compliance with good scientific and regulatory practices.
  • Writes and executes laboratory investigations for known lab errors and Out of Specification (OOS) results using the current electronic deviation system and/or other QC procedures.
  • Participates in investigations for PET process areas related to QC processes or data.
  • Trains QC employees in good analytical techniques, methods and instrumentation based on expertise.
  • Troubleshoots methods and processes.
  • Executes laboratory processes in compliance with GMPs, site and corporate policies, standard operating procedures (SOPs) and test methods. Immediately reports deviations that have the potential to compromise product quality.
  • The role may include shift work.
  • Performs testing on a range of samples, including finished products, water, and environmental samples.
  • May perform sampling activities of various types in the facility (e.G., swabs.).
  • Dispose of flammable materials in the 90-day accumulation container.
  • Maintains and troubleshoots testing equipment.
  • Provides and follows up on ideas for continuous improvements in laboratory processes.
  • Performs project work.
  • Trains QC employees in GMP, SHE, QC methods and processes.
  • Troubleshoots methods and processes.
  • May serve as an expert in a specific area of laboratory equipment, process, or system.
  • Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role.
  • Complete all required training on the Client's Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
  • Ensures compliance with the Client's Corporate Policies and Directives, site Standard Operating Procedures, site policies, work instructions, regulatory requirements, and industry best practice (cGMPs, GAMP, ITIL, PMI).
  • Maintains a safe work environment and performs work in accordance with site, Safety, Health, and Environment (SHE) policies and procedures.
  • Immediately report potential unsafe conditions to management.
  • Supports internal, external, and regulatory inspections including FDA, EMEA, and third-party inspections.
  • Participates in the investigation and resolution of product quality problems.

This 10+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Margo: margo@alphaconsulting.Com


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Margo Emling

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