Manufacturing Visual Inspection

Aequor; Fremont (CA); On-site; USD 45,000 - 65,000; Full time

Job summary

Aequor in Fremont, CA is seeking a Manufacturing Visual Inspection Associate to execute routine unit operations in visual inspection for drug product manufacturing in a multi-product facility.

The role includes advanced visual inspection, palletizing, cleaning, hood preparation, BioMES operations, batch record execution, equipment use logs, and support of filling and packaging, with strict adherence to cGMP, cGDP, SOPs, and safety standards.

Qualifications

• GMP-regulated environment experience required.
• High school diploma or GED required; higher education preferred.
• Ability to read SOPs and manufacturing instructions.

Responsibilities

• Execute routine visual inspection activities related to drug product manufacturing.
• Perform advanced visual inspection, palletizing, cleaning and hood prep.
• Execute BioMES operations and manage exceptions.
• Provide support for drug product filling and packaging.
• Document activities in cGMP and cGDP compliance and maintain batch records.

Skills

Visual Inspection

Advanced Visual Inspection

Inspection Hood

Cleaning

BioMES Ops

Drug Filling

Batch Records

Equipment Logs

Work Orders

MES

cGMP/cGDP

Logistics Coord

Safety

Quality Investigations

Corrective Actions

Communication Skills

SOPs Reading

Detail Oriented

Teamwork

Education

High School Diploma or GED

Associate's or Bachelor's degree preferred

Tools

MES Software

Job description

Position: Manufacturing Visual Inspection

Location: Fremont, CA

Duration: 12 Months

Schedule: 2nd Shift, Monday-Friday, 2:00 PM-10:30 PM (40 hours/week)

Candidates must successfully pass Vision Testing, including visual acuity and color blindness screening, before starting the assignment.

Job Summary

• The Manufacturing Visual Inspection Associate executes routine unit operations in Visual Inspection related to the manufacturing of drug products in a multi-product facility. The position performs duties under limited supervision while following standard operating and manufacturing procedures.
• The role includes visual inspection, advanced visual inspection, palletizing, cleaning, inspection hood preparation, BioMES operations and exceptions, logistics coordination, batch record execution, equipment use log maintenance, work order initiation and tracking, and support of drug product filling and packaging activities.

Key Responsibilities

• Execute routine visual inspection activities related to drug product manufacturing.
• Perform advanced visual inspection, palletizing, cleaning activities, and inspection hood preparation.
• Execute BioMES operations and manage exceptions.
• Provide support for drug product filling and packaging operations.
• Perform logistics coordination and support production projects.
• Execute and maintain batch records, equipment use logs, and work order tracking.
• Create and maintain training kits and related documentation.
• Document all activities in accordance with cGMP and cGDP requirements.
• Follow site regulations, SOPs, and manufacturing procedures.
• Report abnormalities and deviations accurately and in a timely manner.
• Maintain production areas according to established 5S standards.
• Adhere to safety standards and elevate unsafe conditions appropriately.
• Maintain training compliance and assist in training other technicians and associates when qualified.
• Support investigations, corrective actions, and other quality-related activities.

Required Qualifications

• High School Diploma or GED required.
• Minimum one (1) year of experience in a GMP-regulated environment.
• Associate's or Bachelor's degree, or biotechnology vocational training, is preferred.

Required Skills

• Visual Inspection
• Advanced Visual Inspection
• Inspection Hood Preparation
• Cleaning
• BioMES Operations and Exceptions
• Drug Product Filling and Packaging
• Batch Record Execution
• Equipment Use Logs
• Work Order Initiation and Tracking
• Manufacturing Execution Systems (MES)
• cGMP and cGDP Compliance
• Logistics Coordination
• Safety Standards
• Quality Activities
• Supporting Investigations
• Corrective Actions
• Strong written and verbal communication skills
• Ability to read and understand SOPs and manufacturing instructions
• Ability to perform detailed, quality-focused work
• Ability to document work accurately
• Ability to work within a high-performing team environment

Physical Requirements

• Position requires regular physical activity, including standing and working in a manufacturing environment.
• Lifting requirements may vary based on production activities and are typically up to 25 pounds.