GMP Production Project Lead

Fagron Nederland BV; Canton, Northern (MA, KY); Híbrido; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Fagron US in Canton, MA seeks a dedicated professional to support production projects and change controls, coordinating with multiple departments to meet completion dates. The role requires familiarity with GMP, GxP, and documentation, plus strong writing and cross-functional communication skills.

You will lead meetings, maintain planning tools, update batch records, and ensure compliance with SOPs while driving projects from initiation to completion in a fast-paced production environment.

Formación

• BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience.
• At least one year of experience in an FDA regulated, GMP manufacturing environment.
• Good organizational skills and deductive critical thinking skills required.
• Advanced writing skills required.
• Proficient in MS Office programs, including Word and Excel.
• Strong interpersonal, written, and verbal communication skills. Able to interface positively with team members, company departments, and vendors.
• Proficient with software programs AX and MasterControl

Responsabilidades

• 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, considering impact to validated systems, current drug products, and patient health and safety.
• Work cross-functionally with other teams within the site, as needed, to complete projects, ensuring deadlines are maintained and closely monitors the need for extensions.
• Organize, schedule and facilitate cross-functional team meetings.
• Support production transactions and trouble shooting in ERP systems.
• Update, review and approve production documents, such as batch records, SOPs and forms.
• Gather and analyze data to support investigations and metrics.
• Maintain compliance by performing all training requirements on time for assigned curriculum.
• Follow all applicable Standard Operating Procedures.
• Perform any other tasks/duties as assigned by Management.

Conocimientos

MS Office

Word & Excel

GxP knowledge

Change control

Documentation writing

Communication skills

AX

MasterControl

QA/QC liaison

Educación

BA/BS in science

Herramientas

AX

MasterControl

Descripción del empleo

Fagron US in Canton, MA seeks a dedicated professional to support production projects and change controls, coordinating with multiple departments to meet completion dates. The role requires familiarity with GMP, GxP, and documentation, plus strong writing and cross-functional communication skills.

You will lead meetings, maintain planning tools, update batch records, and ensure compliance with SOPs while driving projects from initiation to completion in a fast-paced production environment.