Broadley-James Corporation designs and manufactures pH and dissolved oxygen sensors for biopharmaceutical companies involved in fermentation and large scale cell culture applications. We service a worldwide customer base and provide in-depth technical support as well as superior sensor products to a demanding industry.
We are seeking a Quality Control Inspector that serves as the primary on-the-floor presence for the Quality Department, acting as the vital link between daily shop-floor operations and the greater Quality department. This role is responsible for safeguarding product quality and regulatory compliance by performing hands-on physical inspections, verifying production and shipping documentation, and enforcing GMP and line-clearance standards in real time. Additionally, this position maintains the integrity of quality records and documented product characteristics by auditing item records, lot traceability, and production notes for accuracy and consistency. By identifying process deviations early, managing non-conforming materials, and relaying objective floor observations and data to Senior Quality staff, this individual ensures only fully compliant products reach the customer.
Schedule
Monday - Friday, 5:30 AM - 2:00 PM
Tasks / Responsibilities
- Verifies Work Order (WO) and Sales Order (SO) accuracy against product specifications. Confirms finished goods are correctly identified, labeled, documented, and ready for shipment. Inspects in-process and finished product using approved measurement tools, drawings, and specifications. Records results and holds suspect product for review.
- Identifies and documents NCRs, process deviations, and potential quality issues. Contributes to the determination of appropriate course of action and escalates according to established procedures.
- Verifies that controlled documents in use on the production floor, such as work instructions, travelers, and inspection criteria, are current and available at the point of use, and reports outdated or uncontrolled copies to the Quality Department.
- Supports NCR process by managing the return of dispositioned materials to production, including but not limited to rework, reuse, sorting, or component recovery, and documentation, inspection and proper release.
- Assists with nonconformance investigations by gathering information, reviewing records, and documenting findings; supports root cause analysis and corrective-action follow-up, and reports recurring or unresolved concerns to the Quality Department.
- Supports customer complaint and returned-product reviews by retrieving lot, work order, and inspection records and providing documented findings to the Quality Department.
- Performs inspections of workstations to verify compliance with appropriate line clearance and established procedures. Escalates identified issues appropriately.
- Monitors scrap handling practices to ensure nonconforming products and materials are properly segregated, routed and recorded in the MRB and ERP tracking systems. Supports the compilation of inspection results, defect counts, and NCR data into routine reports for the Quality Department.
- Supports equipment management activities by verifying/applying equipment identification and status tags, completing/reviewing calibration and preventive maintenance records, and performing/monitoring scheduled activities for completion. Escalates overdue or incomplete activities, missing documentation, and equipment status.
- Supports the maintenance of documented product characteristics by reviewing item records, production notes, and related product information for accuracy and consistency. Identifies discrepancies and corrects them appropriately to support accurate production documentation and order fulfillment.
- Supports accurate component traceability by ensuring adequate lot record keeping at the inventory and WO level.
- Supports senior Quality Department staff during internal audits by gathering records and objective evidence and providing requested information; may also perform assigned areas of internal audits independently to support the effectiveness of the Quality Management System (QMS).
- Collaborates with Production and other relevant departments to communicate inspection findings, support resolution of quality concerns, and carry out approved corrective actions and process improvements.
- Observes and reinforces GMP, safety, and housekeeping expectations on the production floor, and reports unsafe conditions or practices that could affect product quality to the appropriate supervisor.
- Identifies opportunities to improve inspection methods, process consistency, and defect prevention, and provides practical recommendations to Quality leadership.
- Maintains quality records in accordance with established procedures and good documentation practices.
- Supports audit preparation and assigned Quality Management System (QMS) documentation activities.
- Performs other Quality Department activities as assigned.
Abilities
- Ability to accurately interpret engineering drawings, product specifications, and tolerances, and use calibrated precision measurement instruments to evaluate in-process and finished goods.
- Demonstrated ability to independently cross-reference physical measurements, visual observations, and multi-system documentation (Work Orders, Sales Orders, and item records) to distinguish between acceptable tolerances, documentation discrepancies, and actual product non-conformances.
- Keen ability to detect subtle errors in labeling, lot traceability, revision levels, and workstation line clearances across high volumes of production records.
- Ability to systematically 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/safety expectations to production personnel while escalating unresolved or recurring issues to Quality leadership.
- Ability to strictly follow Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Material Review Board (MRB) segregation protocols without cutting corners under production deadlines.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to talk, hear, type and reach with both hands and arms repetitively throughout the day.
- Must have good vision (close, color vision, peripheral, depth perception, 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.
Preferred Experience/ Minimum Qualifications
Minimum Requirements of employee (education, previous use of specific equipment/technologies, prior experience etc.)
- High School Diploma or GED required; Associate’s degree or technical certification in a manufacturing, engineering, or quality-related field preferred.
- 2+ years of hands-on quality control inspection experience in a regulated manufacturing or production environment.
- Demonstrated experience reading technical drawings/specifications and operating standard physical measurement equipment (e.g., calipers, micrometers, gauges).
- Demonstrated ability to independently navigate, query records, and enter data within an ERP platform (preferably NetSuite).
- Demonstrated ability to independently navigate, locate controlled documents, and enter data within an electronic QMS platform (preferably Grand Avenue).
- Working knowledge of Non-Conformance Report (NCR) workflows, Material Review Board (MRB) material segregation, equipment calibration tracking, and Good Manufacturing/Documentation Practices (GMP/GDP).
- Ability to enter data in Microsoft Excel, draft and format basic quality documents in Microsoft Word, and manage daily cross-departmental communications and scheduling using Microsoft Outlook.
Broadley-James Corporation offers many benefits including:
- Competitive salaries
- Medical, dental, vision, and life insurance
- 401(k) plan
- Education assistance
- Corporate sponsored discounted gym membership
- 9+ paid holidays per year
- Vacation and sick pay