Quality Systems Analyst

Kaztronix Piscataway , NJ 08854

Posted 2 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.


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Quality Systems Analyst

Kaztronix