US_MFG Associate, Filling and Visual Inspection

Boehringer Ingelheim•Fremont, CA

1d•$53,600 - $80,400

About The Position

The Manufacturing Associate, Filling and Visual Inspection executes routine unit operations in Filling or Visual Inspection manufacturing as assigned, related to the manufacturing of drug product in a multi-product facility. The role performs duties under limited supervision and according to standard operating and manufacturing procedures. The associate contributes to production, continuous improvement, quality activities, safe operations, and accurate cGMP/cGDP documentation.

Requirements

High school degree and at least one year of work experience in a GMP-regulated industry.
At least one year of experience in a cGMP-regulated industry.
Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the 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.
Ability to work according to assigned schedules and adapt the schedule with advance notice when required.
Ability to exert some physical effort; lifting requirements vary by manufacturing activity and typically involve no more than 25 pounds.
For Visual Inspectors: ability to read and see clearly and to participate in vision testing, including color-blindness testing, with an acceptable result.
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 of age.

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 shift-change pass-downs and interactions 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, in accordance with SOPs and cGMP/cGDP standards.
Assist Senior and Master Associates with real-time identification and correction of problems.
Report abnormalities and deviations accurately and in a timely manner.
Follow safety standards, identify unsafe situations or habits, and escalate them appropriately.
Maintain required training compliance and train technicians and associates on operations after qualifying as a trainer.
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.