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Job Description
Job Title:
Supply Chain Sr.
Associate Location:
Louisville, KY 40299
Duration:
12 months (Extension possible)
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, 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. Labatory skills, quality background would be beneficial, detail oriented, multitasking, teamwork, and strong communication.
previous pharma experience. 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 Basic Qualifications High school/GED + 2 years work experience OR? Associates and 6 months work experience OR? Bachelors 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 Day to
Day 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.
Possible Extension:
Yes Red Flags:
This concerns a remote position but the candidate needs to work on site (LDC) for 3 days a week. Job offer - cannot stay in a company for a long time(more than 1 year)
Interview Process:
2 rounds: Phone screening Onsite Panel interview (will take place at LDC)
