Qualification Management Specialist — GMP & CQV

Skan Ag; Raleigh (NC); Hybrid; 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. 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.