Production & Change Control Specialist

Fagron; Town of Canton (NY); Vor Ort; USD 70.000 - 110.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Comprehensive benefits

Performance package

Global leader in expanding industry

Zusammenfassung

Fagron US is seeking a detail-oriented professional to support production projects, manage change controls, and coordinate tasks across multiple departments. The role requires strong writing, communication, and organizational skills to drive projects from initiation to completion.

You will work with QA/QC, Materials, Warehouse, and Customer Service, ensuring compliance with GMP and GxP standards and updating documents and records accordingly.

Qualifikationen

• BA/BS in science or equivalent combination of education and experience.
• At least one year of experience in an FDA-regulated GMP manufacturing environment.
• Excellent organizational and deductive thinking skills.
• Advanced writing and strong communication skills.
• Proficiency with Word and Excel in MS Office.
• Strong interpersonal, written, and verbal communication; ability to interface with multiple departments and vendors.
• Familiar with AX and MasterControl software.

Aufgaben

• Be the primary contact for projects or activities that occur in support of production.
• Maintain offline planning tools and analysis.
• Support the manufacturing production team and leadership in driving projects to completion.
• Assess processes for change management and generate change controls with appropriate actions.
• Work cross-functionally with site teams to meet deadlines and monitor extensions.
• Organize, schedule and facilitate cross-functional team meetings.
• Support production transactions and troubleshooting in ERP systems.
• Update, review and approve production documents like batch records, SOPs and forms.
• Gather and analyze data to support investigations and metrics.
• Maintain compliance by completing training on time for assigned curriculum.
• Follow all applicable Standard Operating Procedures.
• Perform any other tasks/duties as assigned by Management.

Kenntnisse

Organizational skills

Critical thinking

Advanced writing

Interpersonal communication

Verbal communication

MS Office proficiency

Ausbildung

Bachelor's degree in science

Tools

Microsoft Word

Microsoft Excel

AX

MasterControl

Jobbeschreibung

Fagron US is seeking a detail-oriented professional to support production projects, manage change controls, and coordinate tasks across multiple departments. The role requires strong writing, communication, and organizational skills to drive projects from initiation to completion.

You will work with QA/QC, Materials, Warehouse, and Customer Service, ensuring compliance with GMP and GxP standards and updating documents and records accordingly.