QA Compliance Specialist II

SHARP STERILE MANUFACTURING LLC•Lee, MA

17d

About The Position

The QA Compliance Specialist II is a quality professional who assists with compliance and quality activities at SSM. The QA Compliance Specialist assists with implementing cGMP and regulatory requirements at SSM. The QA Compliance Specialist is responsible for maintaining and improving the Quality Culture at SSM.

Requirements

Three (3) to five (5) years of experience working in a cGMP environment (preferably in a QA function)
Bachelor’s Degree (relevant experience may be substituted for degree)
Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat
Knowledge of an electronic Quality Management System
High attention to detail
Good writing, public speaking, and presentation skills
Ability to sit for prolonged periods of time
Ability to lift up to 25lbs
Ability to stand for prolonged periods of time

Responsibilities

Provide indirect oversight of cGMP operations at SSM, ensuring compliance with regulatory requirements.
Work collaboratively within SSM’s Quality Management System (QMS) to support quality initiatives and continuous improvement.
Author, review, and approve documentation in compliance with FDA, EU, and other applicable regulatory agency requirements.
Manage and process Change Controls, Deviations, CAPAs, Work Orders, and other GMP-related documents, ensuring timely resolution and compliance.
Conduct and support internal audits and routine walkthrough inspections of manufacturing areas, authoring and reviewing associated reports.
Collaborate cross-functionally with other departments to achieve on-time closure of Quality Events and maintain quality standards.
Assist in the execution and oversight of the Pest Control Program, ensuring compliance with facility and regulatory requirements.
Maintain strong organizational skills, with the ability to efficiently review, edit, and manage documentation.
Demonstrate a high level of attention to detail while managing multiple tasks and priorities.
Effectively manage timelines and deliverables to meet department and organizational goals.
Maintain control and confidentiality of all quality-related documents and sensitive information.
Perform other duties assigned by the Quality Manager, supporting the continuous improvement of SSM’s Quality Systems.
Other duties as assigned.
Exhibit a quality mindset
Conduct business in a responsible manner that complies with FDA, EU and other regulatory agency requirements