Quality Assurance Manager

SGS • Christiansburg, VA

2d

About The Position

The Quality Assurance Manager will administrate and develop the quality system based on ISO/IEC 17025, and 21 CFR, Parts 11, 210, 211, 610 and 820. The QAM will be responsible for ensuring IT, Facilities, and the labs are 21 CFR Part 11 Complaint during equipment qualification process and through regular data integrity audits. Additionally, they will ensure that all registrations and certifications for the lab remain current. They will promote continuous improvement of laboratory and business systems with respect to quality. This role will be the face of quality for the entire lab and will interact with customers, vendors and accrediting bodies. Lead the ISO/IEC 17025 and 21 CFR, Parts 11, 210, 211, 610 and 820 Quality System at SGS North America Inc. as a system of continuous improvement. Responsible for ensuring IT, Facilities, and the Labs are 21 CFR Part 11 Complaint during equipment qualification process and through regular data integrity audits. Ensure that all registrations and certifications for the lab remain current. Give leadership and develop the quality system with the Qualtrax Document Management System as a tool for achieving ISO/IEC 17025 requirements and the cGMP compliance in Christiansburg. Provide quality approval for all documentation related to work instructions. Provide one of two approvals for all approvals related to Quality Procedures or major system changes. Lead and administer the Qualtrax Document Management system. Oversee the schedule, training, execution and, closing of the Internal Audits each year. Oversee all non-conformances resulting from Internal and External Audits, Complaints, OOS’s and any other investigations ensuring that the system is suitable for compliance and business practice. Execute all quality agreements or quality surveys sent by the customer. Lead all customer audits, or regulatory body audits representing SGS North America Inc. and providing the required documentation, interaction, and completion of any resulting actions. Interact with all lab staff as necessary to ensure that all quality requirements are understood and executed through effective communication and training. Oversee the Quality Control System including leadership of any changes or improvements. Lead Root Cause Analysis to identify and eliminate sources of non-conformances / lab errors. Manage all Proficiency Testing to help support ISO/IEC 17025 accreditation. Conduct Management Reviews for local lab leadership to promote continuous improvement and adherence to Quality System.

Requirements

• Bachelor’s degree in a related field.
• Minimum 5 years of experience in a Quality Assurance role.
• Language Skills: English
• Mathematical Skills: Intermediate required
• Reasoning Skills/Abilities: Advanced level required
• Excellent verbal and written communication, and interpersonal skills
• Advanced chemical laboratory techniques
• Computer Skills: MS Office, Quality System software

Nice To Haves

• Bachelor’s degree in chemistry or related field
• 4 years of experience in Chemistry or related field
• Experience working in an ISO/IEC 17025 and/or cGMP environment
• Experience working in an FDA regulated environment
• Experience with pharmaceutical and medical device manufacture or testing

Responsibilities

• Administrate and develop the quality system based on ISO/IEC 17025, and 21 CFR, Parts 11, 210, 211, 610 and 820.
• Ensure IT, Facilities, and the labs are 21 CFR Part 11 Complaint during equipment qualification process and through regular data integrity audits.
• Ensure that all registrations and certifications for the lab remain current.
• Promote continuous improvement of laboratory and business systems with respect to quality.
• Lead the ISO/IEC 17025 and 21 CFR, Parts 11, 210, 211, 610 and 820 Quality System at SGS North America Inc. as a system of continuous improvement.
• Give leadership and develop the quality system with the Qualtrax Document Management System as a tool for achieving ISO/IEC 17025 requirements and the cGMP compliance in Christiansburg.
• Provide quality approval for all documentation related to work instructions.
• Provide one of two approvals for all approvals related to Quality Procedures or major system changes.
• Lead and administer the Qualtrax Document Management system.
• Oversee the schedule, training, execution and, closing of the Internal Audits each year.
• Oversee all non-conformances resulting from Internal and External Audits, Complaints, OOS’s and any other investigations ensuring that the system is suitable for compliance and business practice.
• Execute all quality agreements or quality surveys sent by the customer.
• Lead all customer audits, or regulatory body audits representing SGS North America Inc. and providing the required documentation, interaction, and completion of any resulting actions.
• Interact with all lab staff as necessary to ensure that all quality requirements are understood and executed through effective communication and training.
• Oversee the Quality Control System including leadership of any changes or improvements.
• Lead Root Cause Analysis to identify and eliminate sources of non-conformances / lab errors.
• Manage all Proficiency Testing to help support ISO/IEC 17025 accreditation.
• Conduct Management Reviews for local lab leadership to promote continuous improvement and adherence to Quality System.

Benefits

• Medical, dental and vision insurance, life insurance, employee wellness programs
• Competitive pay, 401(k) with company match (immediate vesting upon enrollment), employee referral program
• Online training courses, virtual and classroom development experiences, tuition reimbursement program
• Paid-time off (vacation, sick, company holidays, floating holidays, volunteer time)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees