Supply Chain Sr. Associate

Job Title: Supply Chain Sr. Associate

Location: Louisville, KY 40299

Duration: 12 months (Extension possible)

• Hybrid – 3 days onsite (Tue, Wed, Thu) and 2 days WFH
• Standard hours

• Bachelor's degree or equivalent in Life Sciences + 2 years experience in GMP/GDP compliance
• Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice
• Analytical and evidence-based approach to problems
• Technical writing skills:
  Smartsheet, Excel, PowerPoint, Trackwise
• Local candidate – either based nearby or about 1 hour away from the site
• Nice to have:
  Veeva, SAP

Ideal Candidate: Bachelors + 2 years of working experience. Laboratory skills, quality background beneficial, detail oriented, multitasking, teamwork, strong communication. Technical skills:
Smartsheet, Excel, PowerPoint, Trackwise, Veeva, SAP. Nice to have: previous pharma experience.

Role Overview: We are looking for a Supply Chain professional to own and manage temperature excursions, minor and major deviations, CAPA’s and CAPA EV’s reported in the US region, and to assist in various continuous improvement projects related to GDP topics across the organization. The position collaborates with the GD organization, Quality organizations, IS organization and external vendors, and reports to the Sr.

Manager Supply Chain Compliance.

• Embed the principles of Good Distribution Practices guideline in the US Supply Chain network to ensure 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 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.

• Apply a risk-based approach, make decisions and escalating issues appropriately.

• Contribute to continuously improving the level of GDP compliance in the supply chain network.

Minimum Requirements:

• 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 with Quality Management Software systems (e.g. Trackwise, EDMQ, etc.)

Preferred Requirements:

• Experience in audit/inspection support
• Technical writing skills

• Effective communication skills at multiple levels, areas and countries
• Apply a risk-based approach, making decisions and escalating issues appropriately
• Analytical and evidence-based approach to problems
• Identify connections between issues, common factors and bring stakeholders together
• Pro-active in proposing solutions and driving tasks to completion
• Work autonomously, respecting deadlines
• Maintain a high degree of discipline and attention to detail