QA QMS Associate

Job Title

QA QMS Associate

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

927 Currant Rd,

Fall River, MA

Shift

General (8:30AM - 5:00PM)

Employment Type

Full Time

Salary Range

(Base/salary)

$74,600 - $95,000

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid family leave, employee discounts, and other benefits.

Purpose

The QA QMS Associate position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. This role ensures compliance with both internal and external quality standards at Invagen Pharmaceuticals Inc. Fall River Facility.

Responsibilities/ Accountabilities

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.

* Other duties as reasonably aligned with this role.

Education Qualifications

The ideal candidate's minimum qualifications will include:

* Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is required.

* A bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy) or a related field preferred.

* A master's degree in a field to study relevant to the position is preferred.

Experience

Minimum of 3 years of experience in MDI or combination products is preferred.

Skills/ Competencies

* 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.

Physical Requirements

* This role works in a current Good Manufacturing Practice (cGMP) office, laboratory and manufacturing environment, where personal protective equipment (PPE) may be required, which may include uniforms, lab coats, safety glasses, respiratory PPE, hearing protection, etc.

* Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility may be required.

* Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period may be required.

* Relocation negotiable.

* Must be willing to work long hours and some weekends based on a relevant business need, if required.