MFG Associate, Filling and Visual Inspection, ONSITE, Fremont CA

Boehringer Ingelheim•Fremont, CA

1d•$53,600 - $80,400•Onsite

About The Position

The Manufacturing Associate, Filling and Visual Inspection executes routine unit operations in Filling or Visual Inspection manufacturing, as assigned, related to manufacturing drug product in a multi-product facility. The role performs basic and advanced operations under limited supervision and according to standard operating and manufacturing procedures. This is an onsite position in Fremont, California, on the day shift from 6:00 a.m. to 2:30 p.m. The associate supports production activities and continuous improvement, coordinates with other departments, maintains production areas and supplies, documents work in accordance with cGMP and cGDP standards, and assists senior and master associates with identifying and correcting issues. The role also contributes to quality activities, reports abnormalities and deviations, maintains training compliance, and may train technicians and associates after qualifying as a trainer.

Requirements

High school degree and at least one year of work experience in a GMP-regulated industry.
Ability to concentrate on detail-oriented work in a complex technical setup with a quality and right-first-time mindset.
Strong written and verbal communication skills.
Ability to work with computer-based systems.
Ability to read and understand SOPs and work instructions and document work in writing according to cGMP standards.
Ability to work as part of a high-performing team and collaborate effectively with staff.
May be required to work according to assigned schedules and adapt the working schedule with advance notice.
Ability to exert some physical effort; lifting requirements vary by manufacturing activity and are typically no more than 25 pounds.
For Visual Inspectors: ability to read and see clearly and acceptable results on vision testing, including color blindness testing.
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical, if required.
Must be at least 18 years old.

Nice To Haves

Associate or bachelor's degree from an accredited institution.
Biotechnology vocational training.

Responsibilities

Perform basic and advanced Filling or Visual Inspection operations under routine supervision.
Support low- to moderate-complexity continuous improvement projects in production areas.
Coordinate basic interactions, including shift-change pass-downs and coordination with other departments.
Stock consumables and materials, discard expired reagents appropriately, and recognize and report process or equipment anomalies.
Maintain production areas according to predefined 5S standards.
Document work in controlled documents, including batch records, logbooks, and SOP attachments, according to SOP and cGMP/cGDP standards.
Assist Senior and Master Associates with real-time identification and correction of problems.
Report abnormalities and deviations in a timely and accurate manner.
Follow safety standards, identify unsafe situations or habits, and escalate them appropriately.
Maintain personal training compliance and train technicians and associates on operations after completing trainer qualification.
Participate in training new technicians on basic procedures and troubleshooting minor process issues.
Perform operations and demonstrate broad knowledge of processes.
Contribute to quality activities, including investigations and area walk-throughs.
Document and investigate discrepancies and recognize quality issues.