QA Audit & Compliance Associate

Job Title

QA Audit & Compliance 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 Audit and Compliance Associate is responsible for overseeing, coordinating, and ensuring adherence to regulatory standards, policies, and procedures related to pharmaceutical operations. This role ensures compliance with both internal and external quality standards, including regulatory requirements, industry best practices, and corporate policies at Invagen Pharmaceuticals Inc. Fall River Facility.

Responsibilities/ Accountabilities

The QA Audit and Compliance 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:

* Coordinate during internal and external audits of processes, systems, and procedures to verify compliance with Good Manufacturing Practices (GMP), and other relevant regulations.

* Support and participate in internal audits conducted by Corporate Quality Assurance, Third Paty and Unit Level.

* Support and participate in external audits conducted by regulatory agencies (e.g., FDA) or clients.

* Following up on audit findings, compliance to ensure corrective and preventive actions (CAPA) are implemented effectively.

* Interpreting and applying relevant regulatory requirements (e.g., 21 CFR Part 11,).

* Follow up with cross functional department for timely compliance of audit observations.

* Ensuring data integrity in all quality-related activities.

* Providing training to employees on GMP, compliance requirements, and quality procedures.

* Familiar with pharmaceuticals operation (preferably MDI) to ensure required compliance.

* Participate in continuous improvement initiatives to ensure quality and regulatory compliance throughout the organization.

* Contribute to the implementation of quality systems that improve operational efficiency while maintaining compliance with regulatory standards.

* Prepare and submit regulatory reports as needed, including investigation summaries, audit reports, and any necessary documentation for corrective actions.

* Identify trends or recurring issues during audits and inspections, proposing solutions to management.

* Develop and maintain training materials to ensure that staff is well-versed in compliance expectations and audit readiness.

* Provide training to internal teams on QA compliance, audit processes, and regulatory requirements.

* Track and report on CAPA effectiveness and closure to ensure compliance and continuous improvement.

* Work with departments to develop preventive actions that reduce the risk of recurrence.

* Ensure proper documentation of training, investigations, audit findings, CAPAs, and other quality-related activities.

* Assist in preparing for regulatory inspections (FDA,, etc.), ensuring all necessary documentation is complete and up-to-date.

* Review and maintain compliance documentation, including SOPs (Standard Operating Procedures), batch records, and other regulatory filings.

* Monitor and evaluate compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP).

* Collaborate with cross-functional teams to ensure compliance with regulatory requirements and quality standards.

* 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.