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About the Role
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
- Communicate directly with pharmacy personnel and field representatives to coordinate the receipt of returned complaint samples.
- Manage the shipping and logistics of sending complaint samples to external laboratories or international component vendors when required.
- Execute the secure labeling, logging, and tracking of physical complaint samples upon arrival.
- Perform visual inspections of returned samples to check for physical damage, defects, and overall device functionality.
- Thoroughly document inspection details and technical findings in complaint investigation forms.
- Assist in handling various Quality Management System (QMS) elements, including change controls, CAPAs, deviations, Out-of-Specification (OOS) results, and market complaints.
- Draft, review, and revise Standard Operating Procedures (SOPs) related to Quality Assurance.
- Participate in Failure Modes, Effects, and Criticality Analysis (FMECA) and assist in preparing Quality Management Review (QMR) data.
- Generate data trends for market complaints, deviations, CAPAs, purified water systems, and environmental monitoring (EM).
- Maintain strict compliance with current Good Manufacturing Practices (cGMP) across all procedures.
- Identify and help implement business process solutions to improve compliance system operations, efficiencies, and the user experience.
- Actively participate in internal audits, regulatory inspections, and compliance-related activities.
- Collaborate with team members to identify training needs, assist with new hire orientations, and help deliver improved training programs.
Requirements
- Minimum 2 years of experience.
- Prior internships or co-ops within a regulated life sciences environment (biotech, pharma, or medical devices) are highly preferred.
- Familiarity with basic quality concepts (e.g., ISO 13485, FDA cGMPs, or general laboratory safety) gained through coursework or internships.
- Strong technical writing skills.
- High attention to visual detail.
- Proficiency with standard office software (Excel, Word).
- Strong willingness to learn complex regulatory frameworks.
Skills
- Technical writing
- Attention to visual detail
- Proficiency with standard office software (Excel, Word)
- Quality Management System (QMS) operations
- cGMP compliance
- Data trending
- Risk analysis (FMECA)
- Audit participation
Location
- 7 Oser Avenue, Hauppauge, NY
Work Type
- Onsite
- Full Time
Experience Level
- Minimum 2 years
Education Level
- Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Biomedical Engineering, Nursing, or Pharmacy)
Salary/Compensations
- $66,300 - $86,000
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
About the Company
- Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines.
- 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
- 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.