Qa Inspector Ii - Dpi

Cipla

3+ years

Not Disclosed

Hauppauge

10 Feb. 7, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

QA Inspector II – Hauppauge, NY

Location: Hauppauge, NY | Employment Type: Full-Time (Hourly/Non-Exempt) | Division: Quality Assurance
Salary Range: $20 - $29 per hour

Job Purpose

The QA Inspector II will ensure product quality compliance throughout all phases of manufacturing and packaging at InvaGen Pharmaceuticals, Inc. This role is essential for maintaining cGMP standards, performing in-process inspections, and supporting quality control in a pharmaceutical manufacturing environment.

Key Responsibilities

✅ Manufacturing & Packaging Oversight: Ensure compliance with batch records and specifications.
✅ In-Process Testing: Conduct weight, thickness, hardness, disintegration, and friability tests.
✅ Facility & Equipment Checks: Inspect rooms and equipment prior to manufacturing stages.
✅ Sampling & Inspection: Perform AQL, blend sampling, in-process sampling, and inspections.
✅ Quality Control Support: Prepare and deliver samples to the QC lab for testing.
✅ Equipment Calibration: Maintain standard weights and verify balances (ability to lift up to 100 kg required).
✅ Batch Record Review: Ensure signatures, reconciliations, and data accuracy before moving to the next process step.
✅ Environmental Monitoring: Track and document facility conditions (temperature, humidity, etc.).
✅ Non-Conformance Reporting: Identify and escalate quality deviations to management.
✅ Regulatory Compliance: Adhere to cGMP, safety protocols, and documentation standards.
✅ Customer Complaint Support: Conduct testing and create reports for product complaints.
✅ Other Duties: Perform additional tasks as assigned by management.

Qualifications & Experience

📌 Education: High school diploma (required); equivalent credentials (e.g., GED) accepted.
📌 Experience: Minimum 3 years in pharmaceutical quality assurance.
📌 Technical Skills: Knowledge of cGMP, batch records, and regulatory requirements.
📌 Software Proficiency: Microsoft Office and scientific-based software.
📌 Communication: Must be fluent in English (speaking, reading, and writing).
📌 Organizational Skills: Strong ability to multi-task, problem-solve, and maintain accuracy.

Key Competencies

🔹 Attention to Detail – Ensures precision in testing and documentation.
🔹 Team Collaboration – Works efficiently with QA, QC, and manufacturing teams.
🔹 Problem-Solving – Identifies and addresses quality issues.
🔹 Adaptability – Handles multiple priorities in a fast-paced environment.
🔹 Health & Safety Compliance – Follows OSHA and company safety protocols.

Physical Requirements & Work Environment

✔ Standing/Walking – 75% or more of an 8-hour shift.
✔ Lifting – Ability to lift up to 35 lbs. unassisted.
✔ PPE Usage – Must wear lab coats, safety glasses, respirators, and other protective equipment.
✔ Work Conditions – Exposure to solvents, powders, and pharmaceutical materials.
✔ Shift Hours: General (8:30 AM – 5:00 PM); may require weekend/holiday shifts.
✔ No Remote Work / No Relocation Assistance.

Benefits Package

📌 401(k) Savings Plan + Matching
📌 Medical, Dental, & Vision Insurance
📌 HSA & FSA Options
📌 Paid Time Off (PTO) – Vacation, Sick, & Flex Days
📌 Paid Holidays
📌 Short-Term & Long-Term Disability (STD/LTD)
📌 Parental Leave & Family Leave (Paid & Unpaid)
📌 Employee Discounts & Other Perks

About InvaGen Pharmaceuticals, Inc.

InvaGen Pharmaceuticals, a Cipla subsidiary, develops, manufactures, and markets generic prescription medicines across various therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and antidepressants. With headquarters in Hauppauge, NY, InvaGen continues to expand its presence in the U.S. pharmaceutical market.

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Qa Inspector Ii - Dpi

Job Description

QA Inspector II – Hauppauge, NY

Job Purpose

Key Responsibilities

Qualifications & Experience

Key Competencies

Physical Requirements & Work Environment

Benefits Package

About InvaGen Pharmaceuticals, Inc.

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