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QC Scientist
- Contract
- Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
- United States
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QC Scientist - Contract - Onsite
Proclinical Staffing is seeking a QC Scientist to join cutting-edge recruiting firm. This is a contract role located in Mount Vernon, IN.
Skills & Requirements:
- Bachelor degree or a minimum of 2 years of demonstrated relevant experience in Quality Control lab setting.
- High level of knowledge and competence with a specific piece of laboratory equipment, or a QC/QA 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 Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
- Ensures compliance with AZ 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
The QC Scientist will:
- 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 and weekend 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 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.
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or j.cerchio@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDCQA
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