QA QMS Associate

Job Title

QA QMS Associate

FLSA Classification

Full Time, Exempt Professional

Work Location

Fall River, MA

Work Hours/Shift

General Shift: 8:30AM - 5:00PM (May vary based on business needs)

Reports To

QMS Lead

Salary Range

$62,400 - $75,400

Job Purpose

The QA QMS Associate is responsible for ensuring that the company’s products and processes comply with regulatory standards and internal policies. They work to maintain and improve the Quality Management System (QMS) to ensure the quality, safety, and efficacy of pharmaceutical products. at InvaGen Pharmaceuticals Inc. Fall River Facility.

Duties And Responsibilities

The QA QMS Associate position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The essential and typically expected job duties for this position include but are not limited to the following:

• Assist in the development, implementation, and maintenance of the QMS in line with GMP (Good Manufacturing Practice) and regulatory requirements (e.g., FDA,).
• Maintain and ensure the proper documentation of all quality systems and records.
• Oversee document control processes, ensuring that SOPs (Standard Operating Procedures), work instructions, and other quality documents are up to date and correctly implemented.
• Assist in the collection, analysis, and reporting of quality data (e.g., quality metrics, CAPA (Corrective and Preventive Action) reports, audit findings).
• Support investigations of deviations, non-conformances, and customer complaints, ensuring appropriate follow-up and resolution.
• Provide training and guidance to employees on QMS-related processes and regulatory requirements.
• Ensure that the company remains compliant with all regulatory requirements (e.g., FDA, ICH, EMA).
• Support risk assessments and help mitigate any potential quality risks to product safety and compliance.
• Familiar with pharmaceuticals operation (preferably MDI) to ensure required compliance.
• Familiar with TrackWise applications for handling Deviation and CAPA.
• Prepare and review the investigation related to deviation, OOS, market complaints and microbiological failure.
• Prepare and review the trend related to various QMS elements like Deviations, CAPA, Change Request and Environmental monitoring etc.
• Preparation and review of the Annual Product Quality Review.
• Fulfil the requirement of regulatory submission while closely working with regulatory teams.
• Prepare and review risk assessment (FMECA) for various facility, equipment, process and particular event etc.
• Prepare and review elemental impurities risk assessment and nitrosamine related risk assessment.
• Prepare audit reports, documenting findings, and provide actionable recommendations for improvement.
  
  

Education

• A bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy) or a related field
• Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.
• Experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment is preferred.
• Minimum 3 year of experience in MDI or combination products is preferred.
  
  

Experience

• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
• Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Proficiency in the English language to include usage, spelling, grammar, and punctuation.
• Must have current Good Manufacturing Practices (cGMP) knowledge.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and leadership skills (written, verbal, and presentation).
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.
  
  

Professional and Behavioral Competencies

• Must be willing to work in pharmaceutical manufacturing and packaging quality assurance.
• Work schedule may be Monday to Friday.
• Must be willing to work some weekends based on business needs as required by management.
• No remote work available.
  
  

Physical Requirements

• Work standing or walking unassisted for 75% or greater of an 8-hour period. Unassisted lifting up-to 10 kg, may be required.
• Able to always wear appropriate personal protective equipment, when required.
• Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.
  
  

Working conditions

This role works in a cGMP manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. Work with or around solvents, powders, or other materials commonly found in a pharmaceutical manufacturing facility is required.

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

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.