Supply Chain Sr. Associate

Creative Solutions Services, LLC; Louisville (KY); Hybrid; USD 65,000 - 95,000; Full time

Job summary

Creative Solutions Services, LLC in Louisville, KY is seeking a Sr Associate Supply Chain Compliance to own GDP/GMP compliance tasks in the US region, manage temperature excursions, deviations, CAPA and CAPA EV records, and support continuous improvements across GDP topics.

You will collaborate with GD, Quality, IS and external vendors; report to the Sr Manager Supply Chain Compliance; requires Bachelor's in Life Sciences and 2+ years GMP/GDP; English fluency; hybrid work arrangement (Onsite

Qualifications

• Bachelor's degree in Life Sciences or equivalent with 2 years' GMP/GDP experience.
• Solid knowledge of QA principles, GMP and GDP.
• Analytical, evidence-based problem solving.
• Strong technical writing skills (Smartsheet, Excel, PowerPoint).
• Fluency in English and clear communication.
• Experience with Quality Management Software systems (e.g., Trackwise, EDMQ).

Responsibilities

• Own and manage temperature excursion records.
• Own and manage minor and major deviation records; lead root cause analyses.
• Own CAPA and CAPA EV records; ensure implementation.
• Manage missing product notifications and lead Event Review Team meetings as needed.
• Support audits and inspections.
• Maintain up-to-date Smartsheet records for GDP related items.
• Support continuous improvement initiatives.

Skills

GMP / GDP compliance

Quality Assurance principles

Analytical thinking

Technical writing

Fluency in English

Effective communication

Risk-based decision making

Education

Bachelors degree in Life Sciences

2 years of GMP / GDP experience

Tools

Smartsheet

Excel

PowerPoint

trek wise

Veeva

SAP

Job description

Note: Hybrid - 3 days Onsite (Tues, Wed, Thurs) 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, trek wise
• 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. Labatory skills, quality background would be beneficial, detail oriented, multitasking, teamwork, and strong communication.

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

Sr Associate Supply Chain Compliance

We are looking for a Supply Chain professional to own and manage temperature excursions, minor and major deviations, CAPA's and CAPA EV's that are reported in the US region and to assist in various projects with related to continuous improvements and GDP topics across the organization.

Parties involved are the GD organization, Quality organizations, IS organization and external vendors.

The position will report into the Sr. Manager Supply Chain Compliance.

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.

Authority

• Ability to apply risk-based approach, making 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 in 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
• Ability to apply risk-based approach, making decisions and escalating issues appropriately
• Analytical and evidence-based approach to problems.
• Ability to see the connection between issues, to identify common factors and bring the correct stakeholders together.
• Pro-active in proposing solutions and driving tasks to completion
• Works autonomously, respecting deadlines
• Works with a high degree of discipline and attention to detail

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