by Position: Quality Assurance Supervisor
Company: Cipla USA (InvaGen Pharmaceuticals subsidiary)
Location: Hauppauge, New York, USA
Type: Full-time | Onsite | Mid-senior Level
Job Overview
Cipla USA is looking for an experienced Quality Assurance Supervisor to join its growing operations in Hauppauge, New York. This role involves managing QA activities across laboratory and manufacturing functions to ensure strict compliance with cGMP, GLP, and regulatory requirements. The ideal candidate will bring strong technical expertise, leadership skills, and hands-on experience in analytical quality assurance.
Key Responsibilities
As a Quality Assurance Supervisor, you will be responsible for:
- Reviewing and confirming compliance of protocols, method validation/verification, and comparison reports.
- Ensuring laboratory teams follow current Good Laboratory Practices (cGLP) during routine operations.
- Verifying Standard Operating Procedures (SOPs), test procedures, and process validation documents.
- Coordinating with Regulatory Affairs and Analytical Laboratory teams to prepare documents for ANDA submissions.
- Maintaining proper documentation systems including tracking, storage, and archival.
- Reviewing laboratory raw data, including audit trails, for accuracy and compliance.
- Identifying process gaps during audits and recommending improvements.
- Participating in investigations, incident reviews, and ensuring corrective actions.
- Evaluating compliance for raw materials, in-process, and finished product analytical records.
- Conducting periodic internal audits within the analytical laboratory.
- Implementing changes from updated Pharmacopoeia editions, supplements, and amendments.
- Supporting cross-functional projects as assigned by the manager.
Education & Experience
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field (Master’s preferred).
- 8–15 years of pharmaceutical QA/Quality Control experience.
- Minimum 5 years in a cGMP pharmaceutical manufacturing environment.
- Proven knowledge of Analytical Quality Assurance (AQA).
- Strong experience with APIs, formulations, QC, GLP/GMP/GDP compliance, USP monographs, FDA & ICH guidelines.
- Proficiency in Microsoft Office and QA software applications.
Technical Expertise
- Skilled in operating and reviewing audit trails for laboratory equipment: HPLC, UV-Vis Spectrophotometer, GC, Potentiometer, pH meter, Stability Chambers, etc.
- Strong understanding of regulatory standards (FDA, ICH, USP).
- Capable of troubleshooting, conducting investigations, and identifying root causes.
- Experience in inhalation dosage forms (DPI) is an added advantage.
- Ability to support internal and external audits at local and federal levels.
- Strong technical writing and documentation skills.
Professional Competencies
- Strong verbal and written communication skills in English.
- Ability to manage multiple tasks in a fast-paced environment.
- Self-starter with excellent organizational and time-management skills.
- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Collaborative team player with strong decision-making and leadership abilities.
Work Schedule & Environment
- Standard weekday schedule; flexibility required for occasional weekends or shifts as per business needs.
- No remote option: this role is fully on-site in a cGMP laboratory/manufacturing setting.
- Use of PPE (lab coats, safety glasses, respirators, etc.) is required.
- Relocation support may be offered for the right candidate.
About Cipla USA
Cipla USA, through its subsidiary InvaGen Pharmaceuticals, is a part of Cipla’s global mission to provide high-quality, affordable medicines across the U.S. market. With a strong portfolio of generics and specialty products, Cipla is known for its uncompromising standards of quality, compliance, and patient safety.
How to Apply
If you meet the above qualifications and are ready to take on a challenging yet rewarding role, apply directly via Cipla USA’s careers page or the official LinkedIn listing.
Click Now: https://careers.cipla.com/search
