Job Title: Quality Assurance (QMS) 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: QA 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

• Bachelors degree Advanced vocational training or education in pharmaceutical manufacturing industrial management or related field of study from an accredited college/university.
• Masters DegreeAdvanced 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.
• 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 Indias 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 Ciplas 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.

Equal Opportunity Employer

Cipla USA & its U.S. Affiliates are committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard towithout regard to race national origin religion age color sex sexual orientation gender identity disability or protected veteran status or any other characteristic protected bylocal state or federal laws rules or regulations.

At Cipla we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one please contact

Pre-employment Process

Applicants who receive a conditional offer must satisfactory complete pre-employment drug testing.

Disclaimer on Pay Ranges

About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience skills education and budget. Salary range may vary based on geographic addition to base salary this position may be eligible for benefits and participation in a bonus program based on performance and company results.