Sr. Manufacturing Technician

Quest Diagnostics•San Juan Capistrano, CA

1d•$66,550 - $119,790•Onsite

About The Position

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

Requirements

Minimum of five (5) years’ experience in Laboratory and/or Manufacturing
High school diploma or equivalent education is required.
FDA and ISO regulations and requirements
Quality processes and systems
Manufacturing / Laboratory process and systems
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.
Prolonged Pipetting and ELISA plate set-ups
Focused attention
Prolonged sitting

Nice To Haves

Minimum of five (5) years’ experience in IVD / pharmaceutical or medical device in Manufacturing or Laboratory
4-year degree is preferred.

Responsibilities

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.

Benefits

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!