Packaging Operator - Shift 3
Simtra BioPharma SolutionsBloomington, Indiana, United States · Posted 1 month agoDescription
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra? Because we:
Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.
Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.
This role:
The Packaging Operator works within the Finishing/Packaging Complex. They inspect, label, and package pharmaceutical products to meet client demand and expectations. They contribute to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. This position reports to the Finishing Supervisor.
Shift 3 Hours: 10:45PM-6:45AM
The responsibilities:
- Label, package, and document per written instructions
- Package product in boxes, cartons, syringes, vials, blisters
- Count materials/product to ensure accurate count
- Apply labels to various components
- Replenish packaging materials to areas/work cells as directed by Group Leader
- Monitor and document TOR (time out of refrigeration)
- Complete batch record protocol steps at the time of performance
- Inspect, verify and track
- Scan printed materials Manually examine printed materials and products to ensure specifications are met, including variable text printed on-line
- Verify incoming materials for use
- Inspect product/materials for defects
- Perform bar code and systems challenges (as applicable) for equipment used
- Complete end of batch reconciliation and count verification
- Retrieve product samples
- Monitor and ensure appropriate downtime and efficiency information is logged accurately
- Set-up, tear down and clear
- Participate and assist with line clearance activities
- Remove batch related materials from production area
- Ensure electronic inventory transactions for inventory tracking movement and material verification are completed
- Clean and clear debris from all work areas
- Dispose of rejects in the appropriate disposal area following reconciliation
- Stage materials in the appropriate designated locations
- Enter and verify information in logbooks, as needed
- Apply representation samples to the batch records as required
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