Quality Assurance Generalist (Mon-Fri 10a-6:30p)

Fagron•Canton, MA

About The Position

The Quality Assurance Generalist is an entry-level position responsible for quality assurance activities associated with cGMP manufacturing and documentation. The role ensures that proper controls are followed and maintained during the manufacturing, processing, packaging, and warehousing of compounded products. The position supports compounding operations and related quality systems, documentation, audits, and quality improvement activities.

Requirements

A college degree, or a high school diploma or equivalent with cGMP experience in a pharmaceutical manufacturing company or similar, is required.
Proficiency in Microsoft Office programs, including Word and Excel.
Ability to work in a fast-paced environment.
Ability to handle a high volume of work and rapidly adapt to a changing environment.
Ability to work positively and professionally with others and develop and maintain strong working relationships with coworkers and management.
Ability to take initiative, ask for and offer help when needed, and work independently without prompting.
Strong attention to detail and focus on quality, accuracy, and accountability.

Nice To Haves

Experience with aseptic technique.
Experience with cGMP document review.
Experience with MasterControl.

Responsibilities

Support execution of product batch records and associated manufacturing and quality systems for compounding processes.
Ensure day-to-day compliance with requirements established for compounded products and the systems supporting compounding.
Assist with identifying and resolving quality-related issues associated with compounding operations.
Review and approve manufacturing batch records, labels, and other batch-related documentation.
Assist with internal, corporate, third-party, and federal or state inspections and audits.
Provide information on local quality-system effectiveness measures, such as right the first time and documentation errors, as assigned.
Participate in quality assurance meetings for product manufacturing and media fill execution.
Ensure cGMP documentation associated with work activities is complete.
Maintain assigned standard operating procedures.
Perform other related duties as assigned.