Shine France · 6 hours ago
Operations Support Specialist
Janesville, WI
Full-time
Onsite
Entry Level
$25/hr - $40/hr
1+ years expSHINE Technologies is seeking an Operations Support Specialist who will assist the Production and Quality teams with Therapeutics’ production batch documentation. The primary responsibility is to review completed batch documentation for compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
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Responsibilities
Review executed batch records for accuracy, completeness, and compliance with internal SOPs and cGMP regulations and coordinate corrections between Operations and Quality Assurance departments
Configure and maintain batch dispensing worksheets
Process and manage label requests, ensuring accurate and timely labeling for all batches
Serve as the primary/point person for weekly production batch review, facilitating communication and documentation flow
Collect, organize, and maintain batch data to support production metrics, trending, and investigations
Support logbook reviews to ensure accuracy, completeness, and compliance
Provide documentation support to production management, including compiling reports, maintaining databases, and supporting training documentation
Support preparation for audits and inspections by ensuring documentation is complete, properly filed, and readily accessible
Perform documentation updates (e.g. SOPs, Work Instructions, Forms, etc.) to support the corrective and preventive action program as well as continuous improvement projects
Assist with continuous improvement initiatives related to documentation practices, data integrity, and cGMP compliance
Various administrative support tasks as needed
Qualification
Required
Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field preferred
1-2 years Experience in pharmaceutical or therapeutics manufacturing, cGMP compliance, and documentation practices
Familiarity with batch record review, and quality systems
Strong organizational skills and attention to detail
Ability to work collaboratively across departments
Excellent communication skills, both written and verbal
Skilled in Microsoft desktop software
Benefits
Comprehensive compensation package
Company
Shine France
Shine, Élu Service Client de l'Année 2025* dans la catégorie Banque en ligne pour entreprises Nous avons créé Shine pour simplifier l’entrepreneuriat.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$12.51MKey Investors
XAnge
2024-06-19Acquired
2018-09-04Series A· $9.3M
2017-07-11Seed· $3.21M
Leadership Team
Nicolas Reboud
Co-founder & CEO @Shine
Company data provided by crunchbase