QA Associate - Customer Complaints

Cipla; Hauppauge, Northern (NY, KY); Hybrid; USD 66,000 - 86,000; Full time

Benefits offered by this job

401(k) matching

Health insurance

HSA

FSA

PTO - vacation/sick/flex time

Paid holidays

STD

LTD

Parental leave

Family leave

Employee discounts

Job summary

Cipla is seeking a QA Associate Product & Complaint Specialist in Hauppauge, NY, to investigate and document customer complaints for drug-device products, ensuring compliance with global regulations. The role covers evaluation of drug and delivery device for failures, ADRs, or user errors.

Responsibilities include sample coordination, logistics, documentation, and QMS support, with emphasis on cGMP adherence and continuous process improvement.

Qualifications

• Strong technical writing skills essential.
• High attention to visual detail required.
• Proficiency with Excel and Word.
• Willingness to learn complex regulatory frameworks.

Responsibilities

• Coordinate sample receipt with pharmacy personnel and field reps.
• Manage shipping/logistics of samples to labs or vendors.
• Label, log, and track physical complaint samples on arrival.
• Perform visual inspection of returned samples for damage and device function.
• Document investigation details in complaint forms.
• Support QMS elements: CAPAs, deviations, OOS, market complaints.
• Draft/revise SOPs related to Quality Assurance.
• Support FMECA and QMR data preparation.
• Generate data trends for market complaints and environmental monitoring.

Skills

Technical writing

Attention to detail

Excel

Word

Regulatory frameworks

Education

Bachelor’s degree in science/technical discipline

Job description

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: QA Associate Product &Complaint Specialist

Shift: GeneralShift: 9:00AM- 5:30PM

Employment Type: Full Time

Salary Range: $66,300 - $86,000

Benefits:

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.

• 401(k) savings plan and matching
• health insurance - medical/dental/vision
• health savings account (HSA)
• flexible spending account (FSA)
• paid time off (PTO) - vacation/sick/flex time
• paid holidays
• short-term disability (STD)
• long-term disability (LTD)
• parental leave
• paid and unpaid family leave
• employee discounts
• other benefits

Job Overview:

The Combination Product Complaint Specialist investigates, processes, and documents customer complaints for integrated drug-device products. This role ensures compliance with global regulations by evaluating both the drug component and the delivery device for technical failures, adverse drug reactions, or user errors

Responsibilities:

• Sample Coordination: Communicate directly with pharmacy personnel and field representatives to coordinate the receipt of returned complaint samples.
• Logistics & Tracking: Manage the shipping and logistics of sending complaint samples to external laboratories or international component vendors when required.
• Sample Preparation: Execute the secure labeling, logging, and tracking of physical complaint samples upon arrival.
• Technical Evaluation: Perform visual inspections of returned samples to check for physical damage, defects, and overall device functionality.

Documentation & QMS Operations

• Investigation Documentation: Thoroughly document inspection details and technical findings in complaint investigation forms.
• QMS Management: Assist in handling various Quality Management System (QMS) elements, including change controls, CAPAs, deviations, Out-of-Specification (OOS) results, and market complaints.
• SOP Maintenance: Draft, review, and revise Standard Operating Procedures (SOPs) related to Quality Assurance.
• Risk & Metrics Support: Participate in Failure Modes, Effects, and Criticality Analysis (FMECA) and assist in preparing Quality Management Review (QMR) data.
• Data Trending: Generate data trends for market complaints, deviations, CAPAs, purified water systems, and environmental monitoring (EM).

Compliance & Process Improvement

• cGMP Compliance: Maintain strict compliance with current Good Manufacturing Practices (cGMP) across all procedures.
• Continuous Improvement: Identify and help implement business process solutions to improve compliance system operations, efficiencies, and the user experience.
• Audit Readiness: Actively participate in internal audits, regulatory inspections, and compliance-related activities.
• Training Support: Collaborate with team members to identify training needs, assist with new hire orientations, and help deliver improved training programs.

Qualifications & Requirements:

• Educational Qualification: Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Biomedical Engineering, Nursing, or Pharmacy).
• Work Experience: minimum 2 years of experience. Prior internships or co-ops within a regulated life sciences environment (biotech, pharma, or medical devices) are highly preferred.
• Basic Knowledge: Familiarity with basic quality concepts (e.g., ISO 13485, FDA cGMPs, or general laboratory safety) gained through coursework or internships.
• Core Skills: Strong technical writing skills, high attention to visual detail, proficiency with standard office software (Excel, Word), and a strong willingness to learn complex regulatory frameworks.

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 economies of the emerging world. Driven by the purpose 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast‑growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.

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

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to 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.