QA & Testing (1)

Job Description

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.

Qualifications

Education and Experience

Required:

Bachelor’s degree in a related field.
Minimum 5 years of experience in a Quality Assurance role.

Preferred:

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

Knowledge/ Skills/ Abilities

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

Our Benefits

We care about your total well-being and will support you with the following, subject to your location and role.

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

Physical Demands of the Job

Stand Frequent (34% - 66%)
Move or traverse Frequent (34% - 66%)
Sit Frequent (34% - 66%)
Use hands Constant (67% - 100%)
Reach with hands and arms Occasional (5% - 33%)
Climb or balance Occasional (5% - 33%)
Stoop, kneel, crouch or crawl Seldom (1% - 5%)
Talk/hear Constant (67% - 100%)
Taste/Smell Never (0%)
Lift/carry/push or pull Occasional (5% - 33%)

Environmental and Work Conditions

Fumes or airborne particles Occasional (5% - 33%)
Toxic or caustic chemicals Occasional (5% - 33%)
Work with explosives Occasional (5% - 33%)
Bio-hazard Seldom (1% - 5%)

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

Quality Assurance Manager

Société Générale de Surveillance (SGS)

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