Quality Technician

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 Precision Assembler who is responsible for performing basic, standardized and repetitive manual assembly operations of Broadley-James Corporation’s manufactured products.

Tasks and Responsibilities:

• Performs and documents final inspection and release of finished goods in accordance with quality

standards, product specifications, and customer requirements.

• Identifies nonconforming product and escalates in accordance established processes.
• Administers the equipment management program, including but not limited to, management of the

Master Equipment List.

• Ensures the timely and accurate completion of internal and external calibration and PM services

and maintains related certificates and records.

• Supports and/or executes IQ (Installation Qualification), OQ (Operational Qualification), and PQ

(Performance Qualification) activities for new and existing equipment.

• Records and tracks product or process nonconformances (NCRs) in accordance with established

procedures, ensuring timely resolution.

• Investigates each nonconformance to determine root cause and propose disposition; promptly

presents draft report to Director of Quality Assurance for review.

• Responsible for the ongoing maintenance of DCR, CAPA, and NCR logs, ensuring that all

applicable information is up-to-date at all times.

• Acts as the primary document control coordinator, overseeing all DCRs to ensure that both

regulatory and internal procedural requirements are met; Ensures implementation tasks are
assigned and completed as identified in DCRs.

• Responsible for document distribution and retrieval to ensure only current, effective controlled

documents are in circulation.

• Assists with the creation, revision, and control of quality documentation, including work instructions,

inspection records, procedures, and forms.

• Ensures adherence to internal quality standards and external regulatory requirements (e.g., ISO

9001, etc.).

• Oversees the Periodic Review process to ensure compliance with established internal

requirements.

• Participates in internal and external audits and support audit readiness activities.
• Collaborates with production, engineering, and other departments to resolve quality issues and

promote continuous improvement.

Abilities:

• Ability to manage confidential information with discretion
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment with excellent attention to detail
• Ability to perform work independently and seek management review for accuracy and soundness
• Ability to problem solve and build logical workflows/processes.

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.

Preferred Experience/ Minimum Qualifications:

• Bachelor’s degree in a related field or an equivalent combination of education and experience

required.

• Minimum 3 years of relevant experience in a Quality based role within a manufacturing environment required.
• Experience working in an ISO 9001 and/or ISO 13485 certified environment required.
• Strong knowledge of applicable regulatory standards and compliance requirements.
• Previous experience with Good Documentation Practices (GDP)
• Proficiency in Microsoft Office Suite and ability to operate standard office equipment.
• Excellent written and verbal communication skills in English, with the ability to build effective

interpersonal relationships.

• Demonstrated ability to analyze problems, think critically, and conduct investigations.
• Working knowledge of bioprocessing principles preferred.

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
• Education assistance

• Vacation and sick pay