Qualification Management Specialist

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

Benefits offered by this job

Major medical, dental and vision for员工

401K with company match up to 6%

Paid parental leave

Vacation and holidays with rollover

Disability insurance

Job summary

SKAN US, Inc. in Raleigh, NC seeks a Qualification Management Specialist to lead testing plans, requalification protocols, and documentation for SKAN equipment. You will support field service, maintain QM trackers, and ensure regulatory compliance in a GMP environment.

The role requires attention to detail, ability to manage multiple priorities, and completion of SKAN Academy within 6 months of hire. Salary range reflects market norms for this function in the US.

Qualifications

• Excellent written and oral communication with customers and technicians.
• Self-motivated with the ability to work independently and prioritize tasks.
• Technical degree or equivalent 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, and project-specific documentation to ensure compliance and quality.
• Review and release maintenance binders with alignment to quality standards and regulations.
• Provide ongoing support to field service by answering inquiries on ReQ processes and documentation.
• Manage multiple priorities with attention to detail and meeting deadlines.
• Maintain and update QM trackers and documentation.
• Perform onsite qualification management activities as required.
• Serve as contact for ReQ topics and deviations with customers.
• Initiate and process deviation reports independently.
• Support additional projects as assigned by the manager.
• Recommend efficiency improvements and stay updated with Consense trainings.

Skills

Excellent communication

Self-motivated

GMP experience

Reading technical documents

Education

Technical degree or equivalent in mechanical/electrical field

Tools

Microsoft Office

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
• Recommend efficiency improvements
• 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

Whether you have a question about our products, need technical support or would like to find out more about our solutions.