Operations Support Specialist
About The Position
SHINE Technologies is seeking an Operations Support Specialist who will assist the Production and Quality teams with Therapeutics’ production batch documentation. The Operations Support Specialist's primary responsibility and focus is the review of completed batch documentation for completeness, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) compliance. This position requires strong organizational skills, attention to detail, and the ability to collaborate across departments. The base salary range for this position is $25.00 - $40.00 per hour plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.
Requirements
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
251-500 employees
