Sr. Manufacturing Technician

Quest Diagnostics Incorporated; San Juan Capistrano (CA); On-site; USD 50,000 - 85,000; Full time

Job summary

An established industry player is seeking a Sr Manufacturing Technician to oversee the manufacturing and in-process testing of IVD products. This role offers a unique opportunity to engage in a variety of tasks, including equipment maintenance, validation activities, and documentation creation. The ideal candidate will have extensive experience in laboratory and manufacturing settings, particularly within the IVD or medical device sectors. Join a forward-thinking company where your expertise will contribute to continuous improvement and compliance with FDA and ISO requirements, all while working in a collaborative environment that values quality and innovation.

Qualifications

• 5+ years in Laboratory and/or Manufacturing required.
• Experience in IVD/pharmaceutical or medical device preferred.

Responsibilities

• Manufacturing and testing of IVD products at the facility.
• Equipment maintenance and troubleshooting within the manufacturing process.

Skills

Record Keeping Skills

Laboratory Analytical Skills

Instrumentation Skills

Analytical Skills

Problem-Solving Skills

PC Literacy

Understanding QSRs Quality System

Education

Associates Degree

Bachelor's Degree

Tools

Minitab

Excel

Word

PowerPoint

Job description

The Sr Manufacturing Technician will be responsible for the manufacturing and in-process testing for IVD products at the San Juan Capistrano facility. Such activities will include among others:

• Manufacturing of product,
• troubleshooting,
• Equipment maintenance
• metrics trending,
• execution of validation activities and
• document creation and revisions

• Manufacturing and assembly of IVD products and kits, and coordination of manufacturing schedule for SJC site manufactured products.
• Creation and revision of label templates in bartender. Implementation of label templates ensuring adequate process controls.
• Conduct process validation runs as part of commercial manufacturing support.
• Revision and creation of manufacturing related procedures. Endure adequate and accurate documentation of device history records, instrument records, PM records etc.
• Support implementation of continuous improvement activities.
• Execute equipment preventive and corrective maintenance to keep production equipment operational.
• Help with troubleshooting of problems within the manufacturing process.
• Create reports and analyze production data / information.
• Ensure all manufacturing related areas are kept organized and clean and in good housekeeping conditions (inclusive of materials areas)
• Ensure full compliance with IVD FDA and ISO requirements.
• Ensure all required training is done on time.

QUALIFICATIONS

Required Work Experience:

• Minimum of five (5) years' experience in Laboratory and/or Manufacturing

Preferred Work Experience:

• Minimum of five (5) years' experience in IVD / pharmaceutical or medical device in Manufacturing or Laboratory
• Laboratory Technician

Physical and Mental Requirements:

• Prolonged Pipetting and ELISA plate set ups
• Focused attention
• Prolonged sitting

Knowledge:

• FDA and ISO regulations and requirements
• Quality processes and systems
• Manufacturing / Laboratory process and systems

Skills:

• Good record keeping skills
• Laboratory analytical skills (pipetting, reagents, etc.)
• Instrumentation skills (plate reader/washers, incubation ovens, shakers, etc.)
• Analytical and problem-solving skills
• PC literate (excel, word, Minitab, PowerPoint, etc.)
• Understand the requirements of a QSRs Quality System. ISO-13485 and GMP environment.

EDUCATION
Associates Degree(Required)
Bachelor's Degree

LICENSECERTIFICATIONS

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.