Senior Labeling Specialist

haemonetics; Kota Batu; On-site; IDR 120,000,000 - 180,000,000; Full time

Job summary

Haemonetics in Indonesia seeks an engineering professional to support labeling development across locations, ensuring compliance with global regulatory requirements for medical devices and pharma labeling.

The role provides technical guidance for labeling platforms and coordinates with SMEs to secure input, changes, and approvals.

Qualifications

• Degree in Engineering, Science, Quality, Manufacturing, or related field.
• CAD software experience is a must.
• Experience in labeling, documentation, quality, or manufacturing support is an added advantage.
• Expertise with Robar or other Enterprise Labeling System, preferred.
• Basic understanding of labeling processes and quality requirements.
• Familiar with artwork formatting and documentation control.
• Familiarity with manufacturing, production and quality assurance environments is required.
• Demonstrates a high commitment to quality.

Responsibilities

• Support the labeling development of all locations in Haemonetics, CMOs, and OEMs.
• Understand Global Regulatory requirements of Medical Devices or Pharma Labeling.
• Provide technical expertise for the Labeling Platform, where necessary.
• Provide follow-up with SMEs and stakeholders to ensure timely input, change management, and approvals.
• Control label documentation, markup, and proofread label text, for distribution to cross-functional partners and/or third-party vendors.
• Write clear manufacturing or process steps, and coordinate its verification and training.
• Create and maintain specifications of products and components by using CAD software (AutoCAD/SolidWorks).
• Submit labeling-related workflows in Agile PLM.
• Issue label part numbers and related items, and maintain accurate change control documentation.
• Lead and/or oversee label projects in compliance with regulatory, commercial, and R&D guidelines.
• Lead project implementations ensuring projects’ stakeholders and manufacuring expectations are aligned (i.e. cut in times, scrap, reworks, etc.).
• Meet with Manager to discuss plans of action and implement action items based on decisions made or written SOPs.
• Perform duties that are to support labeling project goals and/or assignments from Manager.
• Project planning – coordinate with Manager and cross-functional partners to ensure milestones are established, achievable, and completed at or ahead of communicated deadlines.
• Represent the department in meetings and interacts with various departments, to complete projects in a timely manner.
• Review and update Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Update labeling SOPs and WIs, as needed, and write label status reports.

Skills

Labeling

Documentation

Quality assurance

Manufacturing support

Education

Engineering degree

Tools

AutoCAD

SolidWorks

Robar labeling system

Agile PLM

Job description

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

Responsibilities/Essential Duties

• Support the labeling development of all locations in Haemonetics, CMOs, and OEMs.
• Understand Global Regulatory requirements of Medical Devices or Pharma Labeling.
• Provide technical expertise for the Labeling Platform, where necessary.
• Provide follow-up with SMEs and stakeholders to ensure timely input, change management, and approvals.
• Control label documentation, markup, and proofread label text, for distribution to cross-functional partners and/or third-party vendors.
• Write clear manufacturing or process steps, and coordinate its verification and training.
• Create and maintain specifications of products and components by using CAD software (AutoCAD/SolidWorks).
• Submit labeling-related workflows in Agile PLM.
• Issue label part numbers and related items, and maintain accurate change control documentation.
• Lead and/or oversee label projects in compliance with regulatory, commercial, and R&D guidelines.
• Lead project implementations ensuring projects’ stakeholders and manufacuring expectations are aligned (i.e. cut in times, scrap, reworks, & etc.).
• Meet with Manager to discuss plans of action and implement action items based on decisions made or written SOPs.
• Perform duties that are to support labeling project goals and/or assignments from Manager.
• Project planning – coordinate with Manager and cross-functional partners to ensure milestones are established, achievable, and completed at or ahead of communicated deadlines.
• Represent the department in meetings and interacts with various departments, to complete projects in a timely manner.
• Review and update Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Update labeling SOPs and WIs, as needed, and write label status reports.

Requirements: -

• Degree in Engineering, Science, Quality, Manufacturing, or related field.
• CAD software experience is a must.
• Experience in labeling, documentation, quality, or manufacturing support is an added advantage.
• Expertise with Robar or other Enterprise Labeling System, preferred.
• Basic understanding of labeling processes and quality requirements.
• Familiar with artwork formatting and documentation control.
• Familiarity with manufacturing, production and quality assurance environments is required.
• Demonstrates a high commitment to quality.

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