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Open nowPosted 4320 days ago

QA Complaint Co-ordinator

Integrated Resources INC628 open roles

Where
Edison, NJ, United States
Work mode
On site
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Your applicationOpen nowQA Complaint Co-ordinatorIntegrated Resources INC · Edison, NJ, United States

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The clock on this job

Early applications get read.

8.0% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 8.0%7 days
  4. 15.0%14 days
  5. 34.2%30 days
This job: posted 4320 days ago

The posting

Company Description

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

DUTIES & ESSENTIAL JOB FUNCTIONS

• Handling product complaints:initiating/receiving, processing and closing as per applicable standard operating procedures ·

• Interacting with the customer/reporter on a daily basis to acquire information that may be required to effectively investigate a product complaint

o Analyzing the final investigations received from the manufacturing units to ensure accuracy

o Initiating/following up with Vice President Notifications to ensure technical issues are being address

• Following up with Corrective Action/Preventative Action plans to ensure technical issues are being address

• Accurately maintain product complaint logs (softcopy and hardcopy), and complete all filing and closing procedures

• Scanning completed product complaint files and sending to respective departments as needed

• To initiate the revision of standard operating procedures and/or working instructions relating to product complaints

• To initiate and handle deviations related to product complaints, and inquiries, adverse drug events as deemed necessary

• To assist in generating monthly, quarterly and annual metric reports

• To assist in handling medicalinquiries, completing appropriate forms and providing answers when applicable

• To assist in appropriately handling initial receipt of Adverse Drug Events {ADE) and processing it as per applicable

SOPs

• As deemed necessary, to assist in the handling and processing of field alert reports to the FDA

• Other projects, as deemed appropriate

Qualifications

REQUIRED

• B.S. in a science related field an 2-3 year pharmaceutical experience in a quality/technical role

• Strong communication, customer service, and organizationa ski! s

• Must exhibit technical writing ability

• Must be a "go-getter" and exhibit a "can do" personality, and not afraid to bring on challenges

• Able to be efficient, multitask and work independently

• Skill to record the information received promptly and correctly on the appropriate documentation form is a must

• Should be proficient in using Microsoft Office (Excel, Word, Powerpoint, Outlook, etc)

PREFERRED

• Prior Pharmacovigilance/ADE/product complaint handling experience

Additional Information

All your information will be kept confidential according to EEO guidelines.

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