Supply Chain Compliance Specialist
14 hours ago
Job Title: Supply Chain Compliance Specialist
Duration: 12 months contract with high possibility of extension
Location: Louisville, KY (Hybrid)
Pay Rate: $34/hr - $36/hr
Job description:
Hybrid - 3 days (Tues, Wed, Thurs) 2 WFH
Standard hours
We are seeking a Supply Chain Compliance Specialist to own and manage temperature excursions, minor and major deviations, CAPA's and CAPA EV's that are reported in the US region. The ideal candidate will assist in various projects related to continuous improvements and GDP topics across the organization.
The position will report into the Sr. Manager Supply Chain Compliance.
Key Responsibilities:
Embed the principles of Good Distribution Practices guideline in the US Supply Chain network, to ensure that 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 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.
Requirements:
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.
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
Red Flags:
This concerns a remote position but the candidate needs to work on site (LDC) for 3 days a week
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