Logo
Cipla USA

QA Specialist- Complaints

Cipla USA, West Islip, New York, United States

Save Job

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.

Job Title:

Complaint Handling Specialist

Location:

Central Islip, NY

Shift:

General Shift 8:30a - 5:00p

Salary Range:

$72K - $93K

Job Responsibilities

Coordinate investigations for LOE and PQCs received regarding InvaGen manufactured products and Third party manufactured/Packaged.

Reviews the investigation reports submitted by other departments and third-party and writes the summary report to be included in the complaint file.

Works with manufacturing, packaging, Quality Control and other departments as necessary to investigate product quality complaints as well Lack of effect (LOEs). Also, engages 3rd parties for the products manufactured and or packaged outside of Invagen.

Works with Corporate QA.

Works with Call center (third-Party) to gather additional details as needed.

Ensure to capture all the information pertaining to complaints in record.

Responsible for consolidating report information into summary reports.

Responsible for following good documentation practices while documenting information.

Receiving the complaint sample and sending the sample to third-party.

Follow the SOP and Work Instructions.

Prepare trend reports.

Any additional responsibilities as required.

Educational & Experience Minimum HS or AS degree, 3+ years' experience in pharmaceutical complaint handling.

Skills & Competencies The ability to use MS Excel, MS Word, PowerPoint and MS Outlook.

Experience in TrackWise will be preferred.

Must be fluent in English since this role requires correspondence within the US.

About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.

Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.

#J-18808-Ljbffr