QA Operations Specialist

Job Title : Quality Assurance Operation Specialist

FLSA Classification : Professional, Exempt

Work Location : Fall River, MA

Work Hours : General : 8 : 30AM - 5 : 00PM (may vary based on business needs)

Reports To : Quality Assurance Manager

Salary Range : $72,800 - $93,600

Purpose :

The QA operation specialist (MDI) position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team.

The QA operation specialist (MDI) monitors and ensures validation and qualification of facility, utilities, equipment's, processes and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs) and provide guidance to QA associates.

Duties and Responsibilities :

The job duties for this position include but are not limited to the following :

• Review of batch manufacturing / packaging record.
• Review of engineering records such as temperature and humidity data calibration and PM records, pest control records and contractor related functions.
• Review and approval of manufacturing / engineering non-conformances.
• Review and approval of manufacturing / engineering change control, deviation investigation and CAPAs.
• Review and approval of manufacturing / engineering validation and qualification documents.
• Provide daily / weekly updates to shop floor and management regarding the quality highlights / concerns.
• Create lessons learned for training as communication mechanism to shop floor personnel.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report any non-conformances and / or discrepancies to management if applicable.
• Verify functionality of all the equipment and associated controls during the batch run.
• Act as quality lead for all shop floor questions / concerns.
• Backup for shop floor QA Associates.
• Complete other duties or participate in project work as assigned by management.

Education and Experience

Technical Knowledge and Computer Systems Skills

Professional and Behavioral Competencies

Work Schedule and Other Position Information :

GLOBAL 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.

EEO Statement

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.