SCIENTIST MOUNT VERNON, IN *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
ALPHA'S REQUIREMENT #23-00210
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
