QA Specialist

Ashland Specialty Ingredients, GP

Are you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious?

Are you always solving?

Then we’d like to meet you and bet you’d like to meet us.

Ashland has an exciting opportunity for a QA specialist to join our Life Sciences, Quality and regulatory team Ashland Specialty ingredients G.P.

business at our Wilmington aquarius manufacturing location.

This is a very visible, significant role within the Company and the Quality and Regulatory function.

This position will report to Quality Manager on the site.

The responsibilities of the position include, but are not limited to, the following:


*  Maintain and improve the site quality procedure. 


* Good document management practice.


* Support ISO 9001/cGMP activities which include customer complaint management, the stability program, site cGMP validation projects, servicing customer requests, document maintenance and various data gathering/analysis.      


* Establishes and maintains the quality management system. 


* Customer complaint investigation


* Deviation


* SOP/ Work instruction reviews.


* Supplier Risk Assessments


* Supplier Approvals


* MOCs


* Gap Analyses/Assessments


* Internal audit


* Product Stability program


* Maintain and log new products for Halal and Kosher certification.


* Conduct internal CGMP audits.


* Preparing updating regulatory documents


* Raw material compliance


* Responding to quality and regulatory related customer inquiries


* Data integrity


* Support quality good and EHS good catches.


* New product setup in iLIMS


* Global monograph reviews


* Regulatory documentation support for Drug master files


* Regulatory intelligence support


* Back for QC lab.

Inspects output samples to verify consistent quality.


* Identifies potential sources of errors and suggests ways to eliminate them.


* Collaborates with various departments within the organization.


* Ethical Conduct: Adhere to ethical standards in research and data reporting.

Avoid fabrication or falsification of data.


* Risk Assessment: Conduct risk assessments for experiments and activities to identify potential hazards and implement necessary precautions.


* Review batch records and perform final product release through iLIMS and SAP.


* OOS investigation.


* Quality Metrics monitoring.


* Raw material and finished product retesting.


* Product compliance review with respective compendial.


* New lab equipment qualification.

Minimum Qualifications:

 

•              BS in chemistry or biology or equivalent years of experience.

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