QA Associate Customer Complaints

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

Job Title: QA AssociateProduct &Complaint Specialist

Location: 7 Oser Avenue Hauppauge NY (Onsite)

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

Employment Type: Full Time

Salary Range: $66300 - $86000

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.

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:

Complaint Handling & Sample Logistics:

• 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: Bachelors 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 CiplaCipla 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 Indias 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 Ciplas focus has always been on making affordable world-class medicines with a reputation for uncompromising quality standards across the 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 October 2020 InvaGen established its project site in Fall River Massachusetts to support the launch of Ciplas respiratory business in the United States.

Equal Opportunity EmployerCipla 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 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 addition to base salary this position may be eligible for benefits and participation in a bonus program based on performance and company results.