Summary: 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.
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.
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
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.
Local candidate — either based nearby or about 1 hour away from the site.
Nice to have: Veeva, SAP
Pay Transparency: The typical base pay for this role across the U.S. is: $28.00 - $29.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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#AditiConsulting #26-05166
Numbers & Facts
Location
Louisville, KY
Salary
$28–$29 Per Hour
Skills
Analysis Skillsunmatched
Artificial Intelligence (AI)unmatched
Automotive Automationunmatched
Biologyunmatched
Consultingunmatched
Continuous Improvementunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
English Languageunmatched
GMP (Good Manufacturing Practices)unmatched
Health Plan Membershipunmatched
Hospitalunmatched
Insuranceunmatched
Messaging Technologyunmatched
Microsoft Excelunmatched
Microsoft PowerPointunmatched
Product Managementunmatched
Purchasing/Procurementunmatched
Quality Assuranceunmatched
Quality Managementunmatched
Records Managementunmatched
Reimbursementunmatched
Root Cause Analysisunmatched
SAPunmatched
Short Messaging Service (SMS)unmatched
Speech Technologyunmatched
Spreadsheetsunmatched
Supply Chainunmatched
Supply Chain Managementunmatched
Team Lead/Managerunmatched
Technical Writingunmatched
Telephonyunmatched
Word Processingunmatched
Writing Skillsunmatched
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