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Job Details


InWork360

Sr. Manufacturing Quality Specialist (2640019009)

Other

Unknown

Yearly

No

Lodi, Ontario, Canada

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Learn about the [Danaher Business [Register to View] which makes everything possible.
**ESSENTIAL JOB RESPONSIBILITIES:**

* Perform technical duties related to initiating a NC (Non-conformance report) identified by Manufacturing.
* Assist P.E, M.E and F.I on generating, investigating, disposition on any NC request that pertains to or impacts Manufacturing
* Oversee and assist in segregation of non-conforming material physically and systematically as required per Procedures
* Oversee implementation of NC disposition actions in Manufacturing
* Provide work instructions for NC’s for Manufacturing when requested by any NC evaluator
* Responsible for maintaining and tracking manufacturing-owned NC’s in all phases of the process
* Chart the course of NC’s in Rework Schedule
* Ensure NC’s form and in eQMS meet Procedure standard
* Responsible for maintaining and tracking PDRs used in manufacturing
* Responsible to drive any concerns from Manufacturing with any signed of NC’s and PDR’s
* Prepare and present NC’s reports owned by Manufacturing
* Perform interview’s with Associates when an NC’s is initiated
* Evaluate any NC assigned to Manufacturing
* Work closely with Document Specialist to redline any necessary changes to SOPs as action items by NC’s
* Work with Master Planners to drive completion dates on NC’s reworks
* Support Manufacturing Consumables on any NC request
* Support Manufacturing ROBAL Fill/Pack with OC daily report and Inventory report
* Attend and Drive meetings with NC’s
* Train new and regular Associates on eQMS
* Work closely with Quality Department in eQMS
* Monitor and upload PDRs and NC’s in CAMSTAR for Manufacturing
* Perform other duties that are delegated by Management
* Work on varies projects e.g. Kaizen’s, Shin Events, Just do it
* Audit Manufacturing area to ensure Associates following SOP’s
**MINIMUM REQUIREMENTS:**
**Education or Experience (in years): **

* Associates degree or education equivalency and 2-5 years of experience
**Knowledge and skills: **

* Broad technical knowledge of GMP systems and experience
* Understand manufacturing process and quality systems
* Proficient technical writing skills
* Ability to effectively and professionally communicate through verbal and written communication
* Computer skills, e.g., Microsoft Office,Microsoft Excel , electronic documentation system, ERP systems,eQMS
**Physical requirements/abilities: **

* Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions.
Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at [Register to View] />When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful *[Danaher Business [Register to View] tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available [Register to View] />
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [Register to View] [Register to View] to request accommodation.

If you’ve ever wondered what’s within you, there’s no better time to find out.