Qualification Management Specialist

SKAN; Raleigh (NC); On-site; USD 65,000 - 75,000; Full time

Benefits offered by this job

Major medical

Dental insurance

Vision insurance

401K with company match

Paid parental leave

Vacation days

Company holidays

Job summary

SKAN US, Inc. in Raleigh, NC is seeking a Qualification Management Specialist to join our QA/QC team and support regulatory compliant qualification activities for SKAN equipment.

You will develop and review test plans, requalification protocols, maintain QM trackers, perform onsite activities, and serve as a primary contact for ReQ topics with customers. Travel 15-20% and growth opportunities through SKAN Academy.

Qualifications

• Excellent written and oral communication skills for effective customer and technician interaction.
• Self-motivated with the ability to work independently and prioritize tasks.
• Technical degree or equivalent work experience in Mechanical, Electrical, or related technical trade.
• Proficient in Microsoft Office Suite.
• Successfully complete SKAN Academy within 6 months of hire date.
• Knowledgeable in reading technical documents such as Alarm Matrix, Functional Matrix, Functional Specifications, etc.
• Familiar with CQV activities.
• Work experience in a GMP environment.

Responsibilities

• Develop, review, and evaluate test plans, requalification protocols, templates, and project-specific documentation to ensure regulatory compliance, technical accuracy, and high execution quality across all SKAN equipment activities.
• Review and release maintenance binders, ensuring complete and accurate documentation in alignment with internal quality standards and regulatory standards.
• Provide ongoing support to field service representatives by responding to inquiries and offering guidance on ReQ processes and documentation
• Manage multiple priorities effectively while maintaining a strong attention to detail and meeting deadlines.
• Maintain and update QM trackers
• Competently perform onsite activities as required in the qualification management process.
• Serve as a knowledgeable point of contact to discuss ReQ topics and deviations with customers.
• Initiate and process deviation reports independently.
• Support additional projects as assigned by the manager
• Travel requirement: 15-20%
• Recommend efficiency improvements
• Maintain departmental procedures
• Stay compliant with Consense trainings and updates
• Create and review AT and PURE ReQ documentation

Skills

Communication skills

Self-motivation

GMP experience

Reading technical docs

Education

Technical degree or equivalent

Tools

Microsoft Office Suite

Job description

SKAN US, Inc., a world leader in pharmaceutical isolators, based in Raleigh, NC is accepting applications for the position of Qualification Management Specialist. This position is based out of our SKAN US facility in Raleigh, NC. The position reports to the Qualification Manager at SKAN US.

SKAN, headquartered in Switzerland with a strong US presence, is a global leader in the pharmaceutical industry for its cleanroom equipment. This equipment is routinely used in vaccine development, production of pharmaceutical products, and other critical operations to ensure the safety and quality of pharmaceutical drugs.

Our US base is comprised of a parts business, a field service/assembly team, a microbiology team, a documentation qualification department, and a field qualification team, among other administrative functions.

SKAN is experiencing rapid growth and is looking forward to welcoming several members to the SKAN family!

Function Specific Tasks

• Develop, review, and evaluate test plans, requalification protocols, templates, and project-specific documentation to ensure regulatory compliance, technical accuracy, and high execution quality across all SKAN equipment activities.


• Review and release maintenance binders, ensuring complete and accurate documentation in alignment with internal quality standards and regulatory standards.


• Provide ongoing support to field service representatives by responding to inquiries and offering guidance on ReQ processes and documentation


• Manage multiple priorities effectively while maintaining a strong attention to detail and meeting deadlines.


• Maintain and update QM trackers


• Competently perform onsite activities as required in the qualification management process.


• Serve as a knowledgeable point of contact to discuss ReQ topics and deviations with customers.


• Initiate and process deviation reports independently.


• Support additional projects as assigned by the manager


• Travel requirement: 15-20%


• Recommend efficiency improvements


• Maintain departmental procedures


• Stay compliant with Consense trainings and updates


• Create and review AT and PURE ReQ documentation


• Salary Range: $65,000 - $75,000

Qualifications Needed

• Excellent written and oral communication skills for effective customer and technician interaction.


• Self-motivated with the ability to work independently and prioritize tasks.


• Technical degree or equivalent work experience in Mechanical, Electrical, or related technical trade.


• Proficient in Microsoft Office Suite.


• Successfully complete SKAN Academy within 6 months of hire date.


• Knowledgeable in reading technical documents such as: Alarm Matrix, Functional Matrix, Functional Specifications, etc.


• Familiar with CQV activities.


• Work experience in a GMP environment.

What can we offer you?

• An open corporate culture and teamwork


• Short decision-making paths and flat hierarchies


• Intensive orientation and training programs through our SKAN Academy


• Excellent base salary with potential annual bonus opportunity


• Major medical, dental and vision for employee and family


• Short-term and long-term disability for employees


• Paid parental leave


• 401K with 100% company match up to 6% immediately vested


• 15 paid vacation days (minimum) and nine observed company holidays per year, generous rollover policy