Quality Control Inspector

Broadley-James Corporation•Irvine, CA

About The Position

Broadley-James Corporation designs and manufactures pH and dissolved oxygen sensors for biopharmaceutical companies involved in fermentation and large-scale cell culture applications. The Quality Control Inspector is the primary on-the-floor presence for the Quality Department and links daily shop-floor operations with the broader department. The role safeguards product quality and regulatory compliance through hands-on inspections, production and shipping documentation verification, and real-time enforcement of GMP and line-clearance standards. It also maintains quality records and documented product characteristics by auditing item records, lot traceability, and production notes. By identifying deviations, managing nonconforming materials, and sharing objective observations and data with Senior Quality staff, the Inspector helps ensure that only compliant products reach customers. The position works Monday through Friday, 5:30 AM to 2:00 PM, in an office and/or manufacturing environment. It collaborates with Production and other departments on inspection findings, quality concerns, corrective actions, and process improvements. The role also supports audits, investigations, customer complaint reviews, equipment-management activities, and Quality Management System documentation.

Requirements

High school diploma or GED required.
At least 2 years of hands-on quality control inspection experience in a regulated manufacturing or production environment.
Demonstrated ability to read technical drawings and specifications and operate standard physical measurement equipment, such as calipers, micrometers, and gauges.
Ability to interpret engineering drawings, product specifications, and tolerances and use calibrated precision measurement instruments to evaluate products.
Ability to cross-reference physical measurements, visual observations, and Work Order, Sales Order, and item-record documentation to distinguish acceptable tolerances, documentation discrepancies, and product nonconformances.
Ability to detect errors in labeling, lot traceability, revision levels, and workstation line clearances across production records.
Ability to gather objective evidence, review historical batch and inspection records, and compile defect data to support root-cause analyses, customer complaint reviews, and internal audits.
Ability to clearly and objectively communicate inspection findings, process deviations, and GMP and safety expectations to production personnel, and escalate unresolved or recurring issues.
Ability to follow GMP, GDP, and MRB segregation protocols consistently, including under production deadlines.
Demonstrated ability to independently navigate, query records, and enter data in an ERP platform.
Demonstrated ability to independently navigate, locate controlled documents, and enter data in an electronic QMS platform.
Ability to enter data in Microsoft Excel, draft and format basic quality documents in Microsoft Word, and manage cross-departmental communications and scheduling using Microsoft Outlook.
Must be able to talk, hear, type, and repetitively reach with both hands and arms throughout the day.
Must have good close, color, peripheral, and depth vision and the ability to adjust focus.
Ability to use basic measurement tools such as calipers and micrometers.
Ability to work in an office and/or manufacturing environment with standard safety requirements.

Nice To Haves

Associate’s degree or technical certification in a manufacturing, engineering, or quality-related field.
Experience with NetSuite ERP.
Experience with the Grand Avenue electronic QMS platform.
Working knowledge of Non-Conformance Report workflows, Material Review Board material segregation, equipment calibration tracking, and GMP/GDP.

Responsibilities

Verify Work Order and Sales Order accuracy against product specifications.
Confirm finished goods are correctly identified, labeled, documented, and ready for shipment.
Inspect in-process and finished products using approved measurement tools, drawings, and specifications; record results and hold suspect products for review.
Identify and document nonconformance reports, process deviations, and potential quality issues; contribute to determining appropriate actions and escalate concerns according to established procedures.
Verify that current controlled documents, including work instructions, travelers, and inspection criteria, are available at production-floor points of use, and report outdated or uncontrolled copies.
Support nonconformance workflows by managing dispositioned materials returned to production for rework, reuse, sorting, or component recovery, including documentation, inspection, and proper release.
Assist with nonconformance investigations by gathering information, reviewing records, documenting findings, supporting root-cause analysis and corrective-action follow-up, and reporting recurring or unresolved concerns.
Support customer complaint and returned-product reviews by retrieving lot, work-order, and inspection records and providing documented findings.
Inspect workstations for compliance with line-clearance requirements and established procedures, and escalate identified issues.
Monitor scrap handling to ensure nonconforming products and materials are segregated, routed, and recorded in MRB and ERP tracking systems.
Help compile inspection results, defect counts, and nonconformance data into routine reports for the Quality Department.
Support equipment management by verifying or applying identification and status tags, completing or reviewing calibration and preventive-maintenance records, and performing or monitoring scheduled activities; escalate overdue activities, incomplete records, missing documentation, and equipment-status issues.
Review item records, production notes, and related product information for accuracy and consistency; identify and appropriately correct discrepancies.
Support accurate component traceability by ensuring adequate lot recordkeeping at the inventory and Work Order levels.
Support senior Quality Department staff during internal audits by gathering records and objective evidence, providing requested information, and potentially conducting assigned audit areas independently.
Collaborate with Production and other relevant departments to communicate inspection findings, resolve quality concerns, and carry out approved corrective actions and process improvements.
Observe and reinforce GMP, safety, and housekeeping expectations on the production floor, and report unsafe conditions or practices that could affect product quality.
Identify opportunities to improve inspection methods, process consistency, and defect prevention, and provide practical recommendations to Quality leadership.
Maintain quality records in accordance with established procedures and good documentation practices.
Support audit preparation and assigned Quality Management System documentation activities.
Perform other Quality Department activities as assigned.