Quality Assurance Manager

SGS•Christiansburg, VA

21h•Onsite

About The Position

The Quality Assurance Manager will be responsible for administrating and developing the quality system based on ISO/IEC 17025, and 21 CFR, Parts 11, 210, 211, 610 and 820. This role ensures IT, Facilities, and the labs are 21 CFR Part 11 Compliant during equipment qualification and through data integrity audits, and that all lab registrations and certifications remain current. The manager will promote continuous improvement of laboratory and business systems with respect to quality and will serve as the primary quality contact for customers, vendors, and accrediting bodies. The position involves leading the quality system, overseeing documentation, internal and external audits, non-conformances, customer interactions, and the Quality Control System, while also managing Proficiency Testing and conducting Management Reviews.

Requirements

Bachelor’s degree in a related field.
Minimum 5 years of experience in a Quality Assurance role.
Excellent verbal and written communication, and interpersonal skills.
Advanced chemical laboratory techniques.
MS Office, Quality System software.
English language skills.
Intermediate mathematical skills.
Advanced reasoning skills/abilities.

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.
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.
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)