Supply Chain Sr. Associate

Spectraforce Technologies; Louisville (KY); Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

Hybrid work arrangement

Competitive benefits

Job summary

Spectraforce Technologies is seeking a Supply Chain Sr. Associate in Louisville, KY for a 12-month hybrid role. You will own temperature excursions, deviations, CAPAs, and CAPA EVs, coordinating with QA, IS, and external vendors under the Sr.

Manager Supply Chain Compliance. The position emphasizes GDP controls and continuous improvement. The ideal candidate has a Life Sciences background with GMP/GDP experience, strong technical writing skills (Smartsheet, Excel, PowerPoint, Trackwise), and

Qualifications

• Bachelor's degree in Life Sciences or equivalent with 2 years GMP/GDP experience
• Experience with Quality Management Software systems such as Trackwise/EDMQ
• Fluency in English and strong written communication skills
• Nice to have: Veeva, SAP

Responsibilities

• Own and manage temperature excursion records
• Lead root cause analyses for deviations
• Manage CAPA and CAPA EV records and ensure effective implementation
• Oversee missing product notifications and support Event Review Team meetings
• Support audits and inspections and maintain Smartsheet data
• Keep Smartsheets up-to-date for minor/major deviations and CTETs
• Drive continuous improvement initiatives in GDP compliance

Skills

Quality Assurance

GMP/GDP compliance

Analytical thinking

Technical writing

Smartsheet

Excel

PowerPoint

Trackwise

English fluency

Life Sciences background

Education

Bachelor's degree in Life Sciences

4+ years GMP/GDP experience (alternative)

Tools

Trackwise

EDMQ

Job description

Job Title: Supply Chain Sr. Associate

Location: Louisville, KY 40299

Duration: 12 months (Extension possible)

Schedule

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

Top 3 Must Have Skill Sets

• 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.

Accountabilities

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

Authority

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

Outputs

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

Qualifications

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

Competencies

• 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