Quality Assurance Compliance Specialist

The Judge Group; Louisville (KY); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading staffing firm is seeking a Quality Assurance Compliance Specialist for a hybrid role in Louisville, KY. The ideal candidate has a Bachelor's degree in Life Sciences, with at least 2 years of GMP/GDP compliance experience. Key responsibilities include managing temperature excursion records, leading root cause analysis, and supporting audits. This position requires strong communication skills and proficiency with Smartsheet, Excel, and other quality management tools.

Qualifications

• Bachelor's degree or equivalent in Life Sciences with 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 is required.

Responsibilities

• Own and manage temperature excursion records.
• Lead root cause analysis sessions for deviations.
• Manage CAPA records and ensure implementation.
• Support audits and inspections.
• Maintain up to date smartsheets for product records.
• Drive continuous improvement initiatives.

Skills

Laboratory skills

Quality background

Detail oriented

Multitasking

Teamwork

Strong communication

Education

Bachelor's degree in Life Sciences

Equivalent experience in GMP/GDP compliance

Tools

Smartsheet

Excel

PowerPoint

Track wise

Veeva

SAP

Job description

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.

Accountabilities

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

Responsibilities

• 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 smartsheets for minor, major, CTETS and missing products
• Own and support continuous improvement initiatives.

Qualifications

• 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)

Preferred Requirements

• Experience in audit / inspection support