Sr. Quality Specialist

Fagron•Canton, MA

10h

About The Position

The Quality Assurance Senior Specialist is an experienced professional responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition. The role ensures proper controls are followed and maintained during manufacturing, processing, packaging, and warehousing of compounded products. The specialist develops proficiency across three levels of QA tasks, demonstrates subject matter expertise in at least two QA functions, and takes on low- to moderate-complexity QA projects. The role supports batch record execution and the manufacturing and quality systems used in compounding, while ensuring day-to-day compliance with applicable requirements. It also assists with quality issue resolution, inspections and audits, and monitoring the effectiveness of local quality systems. cGMP documentation must meet ALCOA standards, and assigned training standard operating procedures must be maintained. Fagron describes its workplace as dynamic, open, and informal, with opportunities to develop and grow within an expanding international pharmaceutical company. The role offers a competitive salary, comprehensive benefits, and a performance package.

Requirements

College degree and at least eight to ten years of cGMP experience in a pharmaceutical manufacturing company, or an equivalent combination of education and cGMP experience.
Proficiency in MS Office programs, including Word and Excel.
Ability to process information rapidly from multiple sources and communication channels.
Ability to handle a high volume of work and adapt rapidly to a changing environment.
Strong motivation and ability to work independently.

Nice To Haves

Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control, and MasterControl.

Responsibilities

Execute and develop proficiency in Level 1, Level 2, and Level 3 Quality Assurance tasks.
Perform Level 1 tasks, including manufacturing and packaging line clearances, product label review and approval, product label reconciliation, EMS data review, and logbook review and reconciliation.
Perform Level 2 tasks, including batch record issuance, batch record review and approval, incoming material review and approval, form and logbook issuance, testing data review and approval, and event report and associated corrective action review and approval.
Perform Level 3 tasks, including disposition and release of incoming materials and finished products, document control activities, change control and controlled document change review and approval, and moderate-risk deviation review and approval.
Demonstrate subject matter expertise in at least two QA functions and take on assigned QA projects of low to moderate complexity.
Support execution of product batch records and related manufacturing and quality systems for compounding processes.
Ensure day-to-day compliance with requirements for compounded products and the systems supporting compounding.
Assist with identification and resolution of quality issues associated with compounding operations.
Assist with internal, corporate, third-party, and federal and state inspections and audits.
Provide information on measures of local quality system effectiveness, such as right the first time and documentation errors, as assigned.
Ensure cGMP documentation for work activities meets ALCOA standards.
Maintain assigned training standard operating procedures.
Perform other related duties as assigned.