Sr. Manufacturing Technician

Sr. Manufacturing Technician - San Juan Capistrano, CA, Monday to Friday, 9:00 AM to 6:00 PM

Pay range: $66,550 - $119,790/ year

Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Benefits Information:

We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects - physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:

*Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours

*Best-in-class well-being programs

*Annual, no-cost health assessment program Blueprint for Wellness

*healthyMINDS mental health program

*Vacation and Health/Flex Time

*6 Holidays plus 1 "MyDay" off

*FinFit financial coaching and services

*401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service

*Employee stock purchase plan

*Life and disability insurance, plus buy-up option

*Flexible Spending Accounts

*Annual incentive plans

*Matching gifts program

*Education assistance through MyQuest for Education

*Career advancement opportunities

*and so much more!

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 the 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.
• Supportthe 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.

Required Work Experience:

• Minimum of five (5) years' experience in Laboratory and/or Manufacturing
• High school diploma or equivalent education is required. 4-year degree is preferred.

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 QSR's Quality System. ISO-13485 and GMP environment.

Qualified applicants with arrest or conviction records will be considered for Employment in accordance with the following laws if applicable, the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act.

Quest believes that conviction records may have a direct, adverse, and negative relationship to the following job duties: accessing company property, information, assets, and products including sensitive information; accessing customer data or confidential information, and partnering and regularly working with or supervising other Quest employees and interacting with Quest customers.