Overview
QC Analytical – Gas Chromatography Specialist Jobs in Charles City, IA at Unity Health
SUMMARY
The Investigation Specialist is responsible for driving the resolution of product quality related issues and complaints by gathering and analyzing relevant information, determining the accurate root cause and defining appropriate corrective/preventive actions to prevent recurrence meeting regulatory (FDA, DEA, Boards of Pharmacy) expectations. The specialist will ensure CAPA effectiveness and assist in leading QMS communication within the organization.
This is an on-site position in Ocala, FL.
Essential Functions and Responsibilities
Perform investigations independently to assess aberrant events impacting product quality that could prevent product release. Perform interviews and schedule follow-up meetings in response to investigations.
Perform gap assessments and root cause analysis evaluations to determine RISK level utilizing root cause analysis tools such as FMEA, fishbone, and/or 5 Why tools.
Ensure root cause analyses, CAPA effectiveness checks and risk analysis for products, processes and systems
Gather data and perform trending
Recommend quality process improvements to increase efficiencies and performance of systems,
Education and Experience:
3 – 5 years of hands-on experience in Quality/Pharmaceutical environment preferred
Bachelor’s degree preferred
Proficiency in technical writing
Experience with root cause analysis tools
Demonstrated “change agent” skills; inclusive of influence management, project management, vision development, and people motivation skills.
Effective written and verbal communication, interpersonal and organizational skills.
Must be results-oriented, able to make decisions independently using critical thinking skills, and able to prioritize work per business needs
Strong knowledge of GMPs and FDA, DEA, BoP regulatory requirements
Job Type: Full-time
Pay: From $24.00 per hour
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Employee discount
Flexible schedule
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
Monday to Friday
Weekends as needed
Application Question(s):
Do you havea Bachelors Degree (BA/BS) in Science (Chemistry, Microbiology or Biology) or Engineering, Quality Management or related field? –(Preferred)
Do you have at least 3 to 5 years’ experience in Quality/Pharmaceutical environment? Required
Do you have experience with root cause analysis/CAPAs? Required
Do you have proficiency in technical writing? Required
Do you have strong knowledge of GMPs and FDA, DEA, BoP regulatory requirements? Required
Ability to Relocate:
Ocala, FL 34474: Relocate before starting work (Required)
Work Location: In person
Title: QC Analytical – Gas Chromatography Specialist
Company: Unity Health
Location: Charles City, IA
