Entry-Level Pharma QA Generalist: cGMP & Aseptic

Fagron; Canton (MA); Sur place; USD 55 000 - 70 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Comprehensive benefits

Performance package

International opportunities

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Attention to detail

Quality assurance mindset

Fast-paced environment adaptability

Independent work initiative

Formation

College Degree or High School Diploma with cGMP experience

Outils

MS Office (Word, Excel)

Description du poste

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.