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

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

Benefits offered by this job

Competitive salary

Comprehensive benefits

Performance package

International opportunities

Job summary

Fagron is seeking an entry-level Quality Assurance Generalist to support cGMP manufacturing quality and documentation. You will ensure proper controls are followed during compounding processes and help maintain batch records, labels, and related documents.

The role requires a college degree or equivalent experience, familiarity with aseptic technique, and proficiency in MS Office. You will work in a fast-paced environment and contribute to internal and regulatory inspections.

Qualifications

• College Degree or High School Diploma with cGMP experience 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 adapt to change.
• Strong teamwork and communication skills.
• Attention to detail and accountability.

Responsibilities

• Support execution of product Batch Records and related manufacturing and Quality systems for compounding processes.
• Ensure day-to-day compliance to requirements for compounded products and supporting systems.
• Assist with problem identification and resolution for quality issues in compounding operations.
• Review and approve manufacturing batch records, labels and related documentation.
• Assist with inspections and audits by internal, corporate, third parties, and federal/state agencies.
• Contribute information on measures of quality system effectiveness.

Skills

Attention to detail

Quality assurance mindset

Fast-paced environment adaptability

Independent work initiative

Education

College Degree or High School Diploma with cGMP experience

Tools

MS Office (Word, Excel)

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.