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

Fagron Nederland BV; Canton (MA); On-site; USD 55,000 - 70,000; Full time

Benefits offered by this job

Comprehensive benefits

Performance package

Job summary

Fagron North America is seeking an entry-level Quality Assurance Generalist to support cGMP manufacturing and documentation for compounded products. You will help ensure controls are followed during manufacturing, processing, packaging, and warehousing activities.

The role requires a college degree or equivalent with cGMP exposure, familiarity with MasterControl, and strong MS Office skills. A fast-paced environment and teamwork are essential as you contribute to compliant operations and quality

Qualifications

• College degree or high school diploma with cGMP experience in pharmaceutical manufacturing is required.
• Experience with aseptic technique and cGMP document review is preferred.
• Proficient in MS Office (Word, Excel) and able to work in a fast-paced environment.

Responsibilities

• Support execution of batch records and manufacturing QA systems for compounding processes.
• Ensure day-to-day compliance with all requirements for compounded products and supporting systems.
• Assist with problem identification and resolution for quality-related issues in compounding operations.
• Review and approve manufacturing batch records, labels and related documentation.
• Assist with internal and external inspections and audits.
• Provide input on quality system effectiveness metrics such as right-the-first-time and documentation accuracy.
• Participate in QA meetings for product manufacturing and media fill execution.
• Maintain cGMP documentation and standard operating procedures.

Skills

Attention to detail

MS Office proficiency

Quality mindset

Team collaboration

Education

College degree or high school diploma with cGMP experience

Tools

MasterControl

Job description

About the Job

The Quality Assurance Generalist is a entry level position responsible for quality assurance activities associated with cGMP manufacturing and documentation. Ensures that proper controls are followed and maintained during the manufacturing, processing, packaging, and warehousing of compounded products.

Pay: $55,000-$70,000 USD Annually

Key Responsibilities

• Support execution of product Batch Records and associated manufacturing and Quality related systems for the compounding processes.
• Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding.
• Assist with problem identification and resolution efforts for quality related issues associated with the compounding operations.
• Review and approve manufacturing batch records, labels and other batch related documentation.
• Assist with internal, corporate, 3rd party and federal/state inspections and audits.
• Provide contributing information on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned.
• Participate in QA 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.

Basic Qualifications

• College Degree or a High school diploma or equivalent with cGMP experience in a pharmaceutical manufacturing company (or similar) required.
• Experience with aseptic technique, cGMP document review and MasterControl preferred.
• Proficient in MS 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 changing environment.
• Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management.
• Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
• Strong attention to detail and focus on quality, accuracy, and accountability.

What's on Offer?

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Ready for the challenge?

Fagron North America is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.