QA QMS Associate

Job Title: QA QMS Associate

Organization: Inva Gen Pharmaceuticals, Inc.

Location: 927 Currant Rd, Fall River, MA

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

Employment Type: Full Time

Salary Range: $74,600 - $95,000

Benefits: In addition to a fulfilling career and competitive salary, the company offers a comprehensive benefits package including 401(k) savings plan with matching, health insurance (medical/dental/vision), HSA, FSA, paid time off (vacation/sick/flex time), paid holidays, short‑term disability, long‑term disability, parental leave, paid family leave, employee discounts and other benefits.

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

• 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 Track Wise 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.

• 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.

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

• 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.

• This role works in a current Good Manufacturing…