Quality Systems Analyst

Kaztronix Piscataway , NJ 08854

Posted 4 months ago

Position Summary:.

Position includes providing Quality Assurance support for Complaints, Deviations, CAPAS, metrics.

Essential Duties & Responsibilities Percentage of Time


Assist with complaint investigations by writing/sending closing letters, organizing complaint samples, retain samples, retrieving associated production records, etc.

25


Review and provide initial approval of minor investigation reports submitted for completeness, errors, accuracy, offer solutions and implement preventative actions to avoid future occurrences of the problem.

25


Process files within TrackWise as appropriate (due dates, assignees, EC s, etc). Provide APR sub-reports for complaints, investigations, FARs, recalls, etc.

15


Provide metrics and KPI s associated with deviations, CAPA, etc.

10


Organize Quality Review Board on weekly basis and Material Review Board as needed including preparing meeting materials.

10


Engage and maintain in a safe and clean work environment by following current good manufacturing practices (cGMP), housekeeping and safety audits (ie. 6S program), and standard operating procedures.

5


Exhibit the company' s Core Values of Ethics, Unity, Humility, Gratitude, Service, Integrity, Fortitude, Respect, Faith, and Growth through all aspects of our performance and leadership while conducting any activities associated with the entity of the company.

5


Additional responsibilities as assigned by manager

5

Position Requirements

Education Required:

Four-year degree in a technical field, preferably in Life Sciences or Engineering

Education Preferred

Masters in a technical field, preferably in Life Sciences or Engineering

Experience Required:

0-2 years of experience in the medical device or pharmaceutical industry

Experience Preferred:

Thorough working knowledge of GMP s and regulatory requirements.

Specialized or Technical Knowledge Licenses, Certifications needed:

Strong computer skills, Microsoft Office Applications (Access, Excel and Word).

Functional Knowledge:

Root Cause Techniques

CAPA System


Company/Industry Related

Knowledge:

Pharmaceutical/regulated products

Solids/Semi-solids manufacturing

Job-specific Competencies

In-depth understanding of Quality control/assurance

Understanding, knowledge, and experience with FDA requirements drugs and regulated products.

Experience with document control/management in a regulated environment

Experience with application and use of Word, Excel, Visio and Project

Knowledge of quality systems in regulated environments.

Skilled at organizing information into a clear concise written form.

Strong working knowledge of editing, proofreading, English spelling, grammar and punctuation.

In-depth understanding of good documentation practices in a GMP environment.

Engage and maintain in a safe and clean work environment by following current good manufacturing practices (cGMP), housekeeping and safety audits (ie. 6S program), and standard operating procedures.


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Lead Systems Consultant IT Quality Assurance

Verizon Communications

Posted 2 months ago

VIEW JOBS 12/4/2018 12:00:00 AM 2019-03-04T00:00 What you'll be doing... In this role, you will manage the customer experience onsite using various Tealeaf modules, Tealeaf UI capture, server installation, and installing/configuring new CX modules. You will also be responsible for: * Create custom events and alerts * Conduct exploratory eventing for ad-hoc requests * Perform analysis consisting of reporting on customer journey/experience for multiple digital platforms * Conduct impact analysis of various issues * Proactively review planned web changes with web teams to identify impact to Tealeaf events, dashboard, reports and alerts What we're looking for... You must have: * Bachelor's Degree or four or more years of work experience * Four or more years of relevant work experience * Digital and mobile app experience. Even better if you have: * Background in telecom * Prior analytical skills or a development background * QA Certifications * Proficient with Excel for data analysis, ex. pivot tables * Familiarity (at the user level) with analytics tools such as Tealeaf CX, Adobe Analytics (a/k/a SiteCatalyst), Google Analytics When you join Verizon... You'll be doing work that matters alongside other talented people, transforming the way people, businesses and things connect with each other. Beyond powering America's fastest and most reliable network, we're leading the way in broadband, cloud and security solutions, Internet of Things and innovating in areas such as, video entertainment. Of course, we will offer you great pay and benefits, but we're about more than that. Verizon is a place where you can craft your own path to greatness. Whether you think in code, words, pictures or numbers, find your future at Verizon. Equal Employment Opportunity We're proud to be an equal opportunity employer- and celebrate our employees' differences,including race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, and Veteran status. Different makes us better. Verizon Communications Piscataway NJ

Quality Systems Analyst

Kaztronix