Job Location
The Ritedose Corporation - Columbia, SC
Position Type
6B
Education Level
High School
Salary Range
$22.71
Job Shift
Day
Job Category
Manufacturing
Description
The 503B Labeling & Packaging Operator is responsible for the Labeling and Packaging of final compounded products with manual and/or automated packaging systems under the direction of Operations. The Labeling & Packaging Operator will work with Quality Assurance personnel to ensure compliance to Standard Operating Procedures and regulatory governance.
Responsibilities:
- Performs Labeling and Packaging of 503B compounded pharmaceutical products.
- Maintain an operational knowledge of any equipment associated with Labeling and Packaging.
- Complies with all policies and procedures related to personnel safety and job area safety.
- Maintains manufacturing records and completes all required documentation in compliance with cGMP, FDA, USP and pharmacy state board regulatory guidelines.
- Participates in stocking materials utilized by the outsourcing department.
- Understands product variations and performs Labeling and reconciliation in accordance with approved manufacturing records.
- Manages the organization of large lots of compounded product / materials and ensure accuracy of label counts and documentation.
- Assists in the execution of other 503B Outsourcing Facility duties as necessary.
Qualifications:
- Minimum 2 years experience in cGMP compounding or pharmaceutical industry preferred
- Familiarity with, and the ability to follow established Standard Operating Procedures, Master Batch Records, and adhere to cGMP
- Strong attention to detail, good math skills, and knowledge of Metric System
- Previous experience operating machinery in a manufacturing environment
- Must be able to spend a majority of time standing
- Must be able to work well both individually and on a team
- Must be able to lift, push, pull and carry up to 40+ pounds