Production Specialist (9am-5:30pm)

Fagron Sterile Services US (FSS); Canton (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Fagron Sterile Services US (FSS) in Canton, MA, seeks a Production Projects Coordinator to support production projects, change controls, and driving completion dates. You will work with Warehouse, Customer Service, Materials Planning, QA and QC, communicating across levels and leading meetings to resolve issues.

The role requires strong writing, proficiency with MS Office, Excel, and ERP knowledge. You will update documents, review batch records, and ensure compliance with GMP and FDA

Qualifications

• BA/BS Degree in science field (e.g., Biology, Microbiology, Chemistry, Pharmacy) or equivalent.
• At least 1 year experience in an FDA-regulated, GMP manufacturing environment.
• Advanced writing skills and strong organizational abilities.
• Proficiency with MS Office (Word, Excel) and ERP systems.
• Strong interpersonal, written and verbal communication skills.

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.
• Cross-functionally collaborate to complete projects while maintaining deadlines.

Skills

Project management

Cross-functional leadership

Written communication

Data analysis

MS Office (Excel/Word)

GxP compliance

Education

BA/BS in science

Tools

AX

MasterControl

Job description

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