Production Specialist (9am-5:30pm)

Fagron Nederland BV; Canton, Northern (MA, KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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

Responsibilities

• 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.

Skills

MS Office

Word & Excel

GxP knowledge

Change control

Documentation writing

Communication skills

AX

MasterControl

QA/QC liaison

Education

BA/BS in science

Tools

AX

MasterControl

Job description

About the job

Responsible for supporting production projects, change controls, overseeing, and organizing production projects to drive to completion dates, other production tasks as assigned.

Must possess the ability to communicate with multiple levels of the organization and make confident decisions regarding product requirements. This position is highly visible and interfaces daily with multiple departments including but not limited to; Warehouse, Customer service, Materials planning/buying, QA and QC. The position requires: working both in a team and as an individual contributor with minimal supervision to manage assigned projects from initiation to completion, familiarity with change controls, documentation updating, excel, word and technical writing. Must be proficient at GxP and possess the ability to effectively communicate and lead meetings independently to drive projects to completion.

Key Responsibilities

• 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.

Set yourself apart

Requirements:

• 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

What's on offer?

• competitive salary
• comprehensive benefits
• performance package
• ability to be part of an international leader in an expanding industry.

Ready for the challenge?

Fagron US 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. Fagron US is proud to be an affirmative action and equal opportunity employer.