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Cipla USA

QA Specialist- Complaints

Cipla USA, Pearl River, New York, United States

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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.

Review the investigation reports submitted by other departments and third‑party and write the summary report to be included in the complaint file.

Work with manufacturing, packaging, Quality Control and other departments as necessary to investigate product quality complaints as well as lack of effect (LOEs). Engage 3rd parties for products manufactured and/or packaged outside of InvaGen.

Work with Corporate QA.

Work with Call Center (third‑party) to gather additional details as needed.

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

Consolidate report information into summary reports.

Follow good documentation practices while documenting information.

Receive the complaint sample and send the sample to third‑party.

Follow 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 U.S.

About Cipla Cipla is a leading global pharmaceutical company dedicated to high‑quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other emerging world economies.

InvaGen Pharmaceuticals, Inc. InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti‑infective, CNS, anti‑inflammatory, anti‑diabetic, and anti‑depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla’s respiratory business in the United States.

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.

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.

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