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

Boehringer Ingelheim•Fremont, CA

1d•Onsite

About The Position

The Manufacturing Associate, Filling and Visual Inspection executes routine and advanced unit operations in Filling or Visual Inspection manufacturing, as assigned, in a multi-product drug-product facility. The position performs duties under limited supervision and follows standard operating and manufacturing procedures. The role is on-site in Fremont, California, on the day shift from 6:00 a.m. to 2:30 p.m. The associate supports production operations, continuous improvement, quality activities, training, and coordination with other departments. Work is documented in accordance with current good manufacturing and documentation practices (cGMP and cGDP), and the associate is expected to maintain training compliance and follow safety standards. The position requires a high school degree and at least one year of experience in a cGMP-regulated industry. An associate or bachelor's degree from an accredited institution or biotechnology vocational training is preferred. Some physical effort may be required, with lifting typically no more than 25 pounds. Visual Inspectors must be able to read and see clearly and pass vision testing, including testing for color blindness.

Requirements

High school degree and at least one year of work experience in a cGMP-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 work schedule with prior 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 obtain an acceptable result 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 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 as assigned.
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, such as 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 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 while demonstrating broad knowledge of processes.
Contribute to quality activities, including investigations and area walk-throughs.
Document and investigate discrepancies and recognize quality issues.