Drug Product Manufacturing Associate II - 2nd Shift
PCI Pharma Services · San Diego, CA · 2 wk ago
AnalystFull-time
About the role
The Manufacturing Associate II plays a crucial role in the production of injectable pharmaceuticals within a GMP environment. This position involves executing tasks according to Standard Operating Procedures (SOPs) and adhering to cGMP regulations.
Responsibilities
- Participate in aseptic manufacturing of injectable pharmaceuticals.
- Assist technical personnel in troubleshooting mechanical issues with manufacturing equipment.
- Perform semi-routine manufacturing tasks as per established SOPs and cGMP guidelines.
- Troubleshoot semi-complex manufacturing processes under cGMP guidelines with supervision.
- Research and implement new methods and technologies to enhance operations.
- Prepare components, media, buffers, and other solutions as needed.
- Accurately document data and write/review batch records under cGMP guidelines.
- Prepare material components for production.
- Ensure regular and reliable attendance on a full-time basis.
- Exhibit professional behavior with both internal and external business associates that reflects positively on the company.
- Align daily actions with department goals and company culture.
Qualifications
- High school diploma required.
- Bachelor’s degree in a science or engineering discipline preferred.
- Minimum of two (2) years of relevant experience in manufacturing, laboratory, mechanical, or engineering positions.
- Detail-oriented with strong written and verbal communication skills.
- Ability to work independently or as part of a team.
- Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
- Familiarity with cGMP, manufacturing, machine operations, and data entry.
- Familiarity with Microsoft Office applications.
Physical Demands
- Constantly perform duties while donning aseptic gowning.
- Constantly required to sit and reach to use computers and other office equipment.
- Frequently required to lift up to 50 pounds.
- Constantly required to view objects at close and distant ranges with hand and eye coordination.
- Frequently required to communicate with others.
Pay
$27.09 - $31.60 per hour plus eligibility for an annual performance bonus.
Schedule
2nd Shift: Starts at 2:00pm
Benefits
- Paid time off
- Health insurance coverage (including dental and vision)
- A flexible spending account
- A 401(k) plan