Quality Assurance Compliance Specialist

Overview

Job Title:
Quality Assurance Compliance Specialist (Supply Chain)

Duration: 1+ year contract

Location:
Louisville, KY 40299

Hybrid - 3 days Onsite (Tues, Wed, Thurs) and 2 days WFH

Ideal Candidate: Bachelors + 2 years of working experience. Laboratory skills, quality background would be beneficial, detail oriented, multitasking, teamwork, and strong communication.

Technical skills
:
Smartsheet, Excel, PowerPoint, trek wise, Veeva, SAP.

Nice to have previous pharma experience.

Embed the principles of Good Distribution Practices guideline in the US Supply Chain network, to ensure that product quality is maintained.

• Own and manage temperature excursion records.
• Own and manage minor and major deviation records and lead root cause analysis sessions.
• Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.
• Manage missing product notifications, including leading Event Review Team meetings if applicable.
• Support audits and inspections.
• Ensure up to date smart sheets for minor, major, CTETS and missing products
• Own and support continuous improvement initiatives.

• Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance
• In the absence of a Life Sciences degree, 4+ years’ experience in GMP / GDP compliance
• Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
• Fluency in English
• Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. Track wise, EDMQ, etc)

• Experience in audit / inspection support