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Quality Assurance Associate III (DPI)

Salary

$0.062k - $0.07540000000000001k

Min Experience

3 years

Location

Hauppauge, NY

JobType

full-time

About the job

Info This job is sourced from a job board

About the role

The purpose of the QA Associate position is to monitor and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs). The essential and typically expected job duties for this position include but are not limited to the following: Perform in-process testing (e.g. weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Conduct room and equipment checks (where applicable) prior to each stage of manufacturing by following detailed written procedures. Execute acceptable quality limit (AQL) sampling and inspections as required. Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab and following detailed documentation procedures to deliver the results to the QC Lab. Maintain records of standard weights and perform daily verification of balances. Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions. Review of 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 all the equipment and associated controls during the batch run. Perform applicable testing and prepare reports for customer complaints. Identify and report any non-conformances and/or discrepancies to management if applicable. Complete other duties or participate in project work as assigned by management.

About the company

Cipla 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 India's 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. Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.) About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is 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. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

Skills

quality assurance
gmp
testing
batch records
equipment monitoring
customer complaints