Quality Assurance and Quality Control Roles (Multiple Positions, NY)

Cipla • Central Islip, NY

397d

About The Position

The Quality Assurance Inspector position at InvaGen Pharmaceuticals involves ensuring compliance with Good Manufacturing Practices (cGMP) and maintaining the quality of pharmaceutical products through rigorous testing and inspection processes. The role is critical in supporting the manufacturing operations at the company's facilities in Central Islip, Hauppauge, and Fall River, focusing on both quality assurance and quality control responsibilities.

Requirements

• Minimum high school diploma or equivalent education credential (ex. GED) required.
• Minimum of three (3) years' experience in quality assurance in a GMP pharmaceutical manufacturing operation.
• Two (2) years of work experience in a laboratory setting.
• Proficient user of Microsoft Office Programs to include Word, Excel, Outlook, PowerPoint, SAP and other business-related systems.
• Must have current Good Manufacturing Practices (cGMP) knowledge.

Nice To Haves

• Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.
• Associates degree or higher in Chemistry, Laboratory Science, or related fields of study from an accredited institution is preferred.

Responsibilities

• Perform in-process testing as per manufacturing batch record instructions.
• Conduct room and equipment checks prior to each stage of manufacturing.
• Execute acceptable quality limit (AQL) sampling and inspect in-process and finished product samples for the Quality Control Lab and ensure isolation of rejected material.
• Maintain records of standard weights and perform daily verification of balances.
• Review engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor related functions.
• Assess online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
• Verify functionality of equipment, perform applicable testing and prepare reports for customer complaints.
• Monitor facility and product environmental operating conditions and identify and report any non-conformances and/or discrepancies to management if applicable.
• Perform sample management for all incoming raw materials, in-process, finished products and stability samples including but not limited to receipt, logging distribution and destruction.
• Coordinate chemical and reference standard inventory in the lab, verifying the expired chemicals and standards and discarding as per company procedures.
• Complete data entry and update all sample information in SAP as per company procedures.
• Maintain lab consumables supply and placing orders as per requirement.
• Oversee temperature and humidity monitoring for stability chambers.
• Conduct sample loading in stability chambers and submitting stability samples as per schedule.
• Assist in the shipment of the samples to contract labs as required.
• Provide general housekeeping in the QC lab and any other functional activity as assigned by management.

Benefits

• Paid time-off
• Health insurance
• Retirement savings plan
• Flexible scheduling options

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: High school or GED
• Number of Employees: 501-1,000 employees