Position: Production Operator
Location: Grand Rapids, MI
Employee Type: Full-Time, Hourly
Manages Others: No
Reports To: Production Supervisor
Organizational Overview
Grand River Aseptic Manufacturing is a privately-held pharmaceutical manufacturer that is located on the Grand Valley State University campus in Grand Rapids, Michigan. We specialize in pre-clinical, Phase 1 and 2 clinical trails and small to medium scale commercial production quantities.
Position Overview
The Pharmaceutical Manufacturing Technician position is a superior entry-level opportunity for individuals interested in science. The position's primary responsibility is to perform various routine manufacturing tasks under the guidelines of established procedures and cGMP regulations under guidance of a production lead and/or senior management.
Responsibilities
- Follow production, manufacturing, and visual inspection procedures and assist in the reviewing process
- Perform equipment preparation, bulk drug formulation, and aseptic filling duties as needed.
- Accurately document data and complete batch records as needed.
- Perform cleaning and sanitization duties as instructed by the applicable procedure.
- Successfully complete facility’s gowning and manufacturing qualification program.
- Execute validation protocols as needed.
- Train in various manufacturing tasks including, but not limited to: fill/finish, formulation, lyophilization, sanitization, component and equipment preparation, and finished product inspection and packaging activities.
- Operate production equipment.
- Inspect, label, and package finished product.
- Perform duties in ISO 5 (Class 100) and ISO 7 (class 10,000) cleanrooms.
- Execute and assist in authoring and reviewing of well-defined procedures. Perform routine maintenance of production equipment.
- Assist in maintaining a warehouse that adheres to FDA regulations. This includes, but is not limited to: hand truck and fork lift operation, receipt and management of incoming materials, sanitization, labeling, shipping, and distribution.
Candidate Requirements
Skills
- Ability to be detail-oriented
- Strong written and verbal communication skills
- Ability to work independently, within prescribed guidelines, or as a team member
- Familiar with Microsoft Office applications
Education
- High school diploma is required
- Associates/Bachelor’s degree or equivalent experience (1-2 years in a manufacturing or laboratory environment) is a plus
- ***National Career Readiness Certificate (NCRC) is preferred but not required***
