Other Key experience needed:
Shop Floor Quality Oversight
*Batch Record Review
*CAPAs (creation, investigation, implementation of action items)
*Customer Complaints (investigation, root cause analysis and implementation of actions)
-Contacts suppliers to schedule routine or for-cause audits
-Plans and prepares agenda and audit plan specific to each supplier
-Coordinates all travel-related plans and activities
-Conducts full quality systems audit of supplier facility in accordance with company procedures and FDA and international guidances.
-Writes descriptive and thorough audit report documents
-Follows-up with suppliers to ensure adequate and timely audit response
-Completes audit process from start to closure within prescribed time limits
-Completes all set ups and includes related documentation in the Master Control audit module
-Assists in writing and updating Standard Operation Procedures and Work Instructions for auditing processes
Bachelor of Science degree in chemistry, biology, natural science or related field is required.
Successful candidate will have significant Chemistry, GMP and Quality Engineering experience.
-An emphasis on quality or chemical discipline is preferred
Minimum of five (5) years of quality assurance experience in a manufacturing environment including significant auditing experience
-Must possess strong knowledge of FDA regulations, ICH Guidelines, IPEC, and cGMP requirements
-Strong familiarity and understanding of regulatory and quality assurance procedures, systems, and operations
-Experience with SAP highly preferred
-Highly proficient in Microsoft Office Suite
-Familiarity with chemical nomenclature and manufacturing terminology, required
LOCATION: Paris, KY 40361
STATUS: 1 year contract
About Advantage Resourcing
Advantage Resourcing makes all employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, ancestry, medical condition, age, marital status, national origin, citizen status, political affiliation, union membership, genetic information, physical or mental disability, veteran status, denial of medical or family leave, pregnancy or pregnancy disability leave or any other protected group status as defined by federal, state or local law. We will provide reasonable accommodations throughout the application or interviewing process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-verify employer.
Our goal is to deliver quality professional services to our clients, while earning confidence through the proper assignment of people. This alignment of people and companies allows us to create opportunity.
Creating opportunities begins by gaining a complete understanding of what makes each company and candidate unique. This is accomplished by working with and listening to the client team and by conducting thorough interviews and skill evaluations with our candidates. Using this knowledge, Advantage Resourcing is able to provide tailored workforce solutions and qualified Talent that are the right fit for each company.
This is Hire Thinking.