QA Complaint Co-ordinator

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.

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

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