Quality Assurance Specialist (QMS)

Job Title: Quality Assurance Production Lead

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

Purpose:

The purpose of the Quality Assurance Production Lead (QMS) 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) and to [provide guidance to Quality Assurance associates.

Scope:

The Quality Assurance Production Lead (QMS) is an individual contributor role and a member of the InvaGen Pharmaceuticals Quality team. The position reports to the Quality Assurance Manager.

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

• Review of batch manufacturing/packaging records.
• Release of raw materials, packaging materials and finished products through approval of respective COA.
• Review of engineering records such as temperature and humidity data calibrations, preventive maintenance records, pest control records and contractor related functions.
• Review and approval of manufacturing/engineering non-conformance.
• Review and approval of manufacturing /engineering change controls, deviation investigations and CAPAs.
• Reviews and approves manufacturing/engineering qualification documents.
• Provides daily/weekly updates to the shop floor and management regarding quality highlights/concerns.
• Creates lessons learned for training as communication mechanism to shop floor personnel.
• Leads manufacturing quality associates on daily activities including the assignment of weekly work schedules.
• Performs training and onboarding of QA associates to ensure they are qualified prior to beginning their daily functions.
• Acts as quality lead for all shop floor questions/concerns.
• Acts as back up for shop floor QA associates.
• Other duties as assigned by department head.

Education and Experience

• High school diploma required.
• Bachelor's degree, Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university is preferred.
• Minimum of five (5) years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.

Technical Knowledge and Computer Systems Skills

• Understanding of machines used in pharmaceutical manufacturing.
• Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Capable of conducting troubleshooting, investigations and root cause identification and analysis.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• Must be proficient in computer skills and software applications such as Microsoft Office tools.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) is a plus.

Professional and Behavioral Competencies

• Proficiently speak English as a first or second language.
• Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.
• Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.
• Knowledge of good manufacturing practices and good documentation practices preferred.

• Ability to read, write and communicate effectively.
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organizational skills with the ability to focus on details.

Work Schedule and Other Position Information:

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
• Must be willing to work some weekends based on business needs as required by management.
• Relocation negotiable.
• No remote work available.

Working condition

This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.

The role may be assigned on a work-shift basis where required (Day, Evening, Night). Weekend or Holiday work may be requested or required based on business needs.

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.

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.