QA Specialist

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. 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 QA Specialist to be responsible for administering quality assurance processes including maintaining documentation, monitoring compliance, analyzing data, and coordinating quality system processes to ensure compliance to regulatory and customer requirements. This role supports the Director of Quality Assurance and cross-functional teams, helps maintain audit readiness, and contributes to continuous improvement initiatives.

Requirements

Ability to analytically review quality data, identify trends, and assess risks to ensure compliance with standards.
Ability to maintain attention to detail by accurately reviewing documentation, reports, and records to catch errors or inconsistencies.
Ability to manage quality files, audit trails, and compliance documents in an organized and systematic way.
Ability to evaluate NCRs, research root causes, and propose corrective and preventive actions.
Ability to communicate clearly in writing and verbally with internal teams, management, and external auditors/customers.
Ability to work collaboratively across production, purchasing, engineering, and management to resolve quality issues.
Ability to understand and apply ISO, GMP, or industry-specific quality frameworks (or ability to quickly learn).
Ability to follow, improve, and enforce procedures consistently.
Ability to effectively prioritize multiple tasks, manage deadlines, and maintain audit readiness.
Ability to use spreadsheets, databases, and quality management software to track, report, and document quality activities.
3 years of experience in quality, compliance, or administrative roles within a manufacturing, distribution, or regulated industry required.
Bachelor’s degree in a related field or equivalent experience, preferred.
Excellent written and verbal communication skills in English.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook) and ability to operate standard office equipment required.

Nice To Haves

Additional coursework or certifications in Quality Assurance, Regulatory Compliance, or ISO standards, preferred.
Demonstrated experience with quality systems, documentation control, or compliance tracking.
Proven background in administrative functions such as maintaining records, preparing reports, and coordinating audits or corrective actions.
Exposure to ISO 9001, GMP, or other industry-specific standards is preferred.
Familiarity with NetSuite or quality management software (QMS) such as Grand Avenue, databases, or reporting tools preferred.

Responsibilities

Acts as the primary document control coordinator, supporting the Director of Quality Assurance to ensure all DCRs meet regulatory and internal procedural requirements; assists with assigning and tracking implementation tasks identified in DCRs.
Assists with the creation, revision, and control of quality documentation, including work instructions, inspection records, procedures, and forms.
Responsible for document distribution and retrieval to ensure only current, effective controlled documents are in circulation.
Records and tracks product or process nonconformances (NCRs) in accordance with established procedures, supporting timely resolution.
Assists in investigating NCRs to determine root cause and draft reports for review by the Director of Quality Assurance.
Ensures adherence to internal quality standards and external regulatory requirements (e.g., ISO 9001).
Oversees the Periodic Review process to support compliance with internal documentation requirements.
Supports the Director of Quality Assurance in managing eQMS and/or related systems by maintaining DCR, CAPA, and NCR logs, ensuring all applicable information is accurate, up-to-date and applies appropriate action in a timely manner in coordination with Director of Quality Assurance.
Supports the administration of the equipment management program, including the Master Equipment List.
Assists in ensuring timely and accurate completion of internal and external calibration and preventive maintenance services, maintaining related certificates and records.
Supports IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) activities for new and existing equipment from a documentation and records perspective.
Participates in internal and external audits and supports audit readiness activities.
Collaborates with production, engineering, and other departments to support resolution of quality issues and promote continuous improvement.
Assists in documenting final inspections and supports the release of finished goods in accordance with quality standards, product specifications, and customer requirements.
Supports the identification of nonconforming products and escalates findings to the Director of Quality Assurance in accordance with established processes.