Auditor, GMP Programs - West Coast - Intertek Testing Services NA Inc

Interested in future career opportunities in the Quality Assurance audit and support services industry? We're looking for GMP Auditors that want to build something great with an incredible group of people. By joining Intertek, your contributions will be valued as we continue to help the world Build Back Ever Better.

Our Value Proposition - We offer:

• A flexible Work Schedule, and the ability to work from home.
• Competitive salary and benefits package including paid time off, medical, dental, vision, life, disability, and 401(k) with company match.
• A flexible work schedule & the ability to work from home.
• Opportunities for growth through training and experience.
• Employee referral bonuses.
• Tuition reimbursement is available in an applicable field.

What will you be doing?

The Auditor, GMP Programs will support the Business Assurance business by leading and/or participating as an assessor during all phases of a client's management system audit, in accordance with the company's accredited certification program. The Auditor is the primary interface with the client before and during the process of all auditing activities. Additionally, the Auditor will help train other team Auditors through witness audits, and provide technical support, and education of both client and sales force as needed.

This will be a travel-based position, with extensive travel to client sites required. Candidate must be comfortable traveling 3 to 5 nights per week. Primarily based on the West Coast, with potential travel to other US regions based upon company needs.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform Second- or Third-Party Assessments of client management systems for compliance to International Standards, client, and/or industry requirements, Government Regulations, and other relevant standards; specifically, ISO 22716 Cosmetic Good Manufacturing Practice, 21 CFR 210/211 Pharmaceutical, 21 CFR 111 Dietary Supplement and/or GMP regulatory requirements that are related to the cosmetic, pharmaceutical, and/or dietary supplement industries.
• Assist clients with questions relevant to the audit and/or certification process.
• Act as Lead Auditor or team member.
• Travel will include overnight 3 to 5 days per week, to various worksites and client locations, primarily based in the Midwest or West Coast.
• Coordinate audit activities with team members.
• Liaison with client regarding audit activity.
• Review client's quality management system documentation.
• Verify and document evidence of compliance and non-compliance.
• Prepare audit reports.
• Review audit results with coordinator and other assessment team members. Make presentations to clients and/or certification board concerning audit results, when required.
• Assist with corrective action requirements resulting from assessments.
• Participate in audit meetings.
• Review audit reports and provide technical assistance to the medical team.
• Support management in areas of continuous improvement.
• Provide management with updates on status of work, initiatives, and projects, as required.
• Travel will include overnight/multiple days, to various worksites and client locations.

What qualifications do you need?

• 4-year college/university degree in a science or technical field (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical, or bioengineering; human physiology; medicine; pharmacy; physics or biophysics) or equivalent combination of relevant education and work experience (H.S plus 6 years' experience).
• A minimum of 4+ years of full-time work experience in a GMP-based or regulated environment (cosmetic, pharmaceutical, dietary supplement, or related industry)
• A minimum of 2+ years in a quality management systems environment (CAPA, internal auditing, supplier complaints, management reviews)
• A recognized auditor qualification from an organization such as ASQ, IRCA, BSI or similar is preferred
• In-depth knowledge of auditing management systems in the relevant cosmetic, pharmaceutical, or dietary supplement industry sector(s)
• Training in quality management systems and/or relevant regulatory requirements.
• Strong communication and interpersonal skills.
• Sound judgment, organizational, and analytical skills.
• Excellent computer and writing skills.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to exercise effective time management skills in the completion of assignments.
• Must be willing and able to travel extensively. Primarily domestic travel, some international travel may be needed.
• Possess a valid unrestricted driver's license and the ability to operate a motor vehicle in the performance of the official duties of the position.

PREFERRED:

• Completed Certified Lead Auditor training for any standard (preferably ISO 9001, but other recognized management system standards are acceptable).
• Related experience or involvement with or performing management systems audits.
• Working knowledge of relevant regulatory requirements for cosmetics and pharmaceuticals in the United States, Canada and/or Asia (China, Taiwan, Korea).
• Experience implementing or auditing ISO 22716 cosmetic, pharmaceutical, dietary supplement, US-FDA and/or Health Canada regulatory requirements.
• Working experience, in a GMP manufacturing environment including hands-on practical experience or training in processes used in the relevant industry's manufacturing processes (e.g.: Cosmetic liquid, creme or stick manufacturing, OTC pharmaceutical, or dietary supplement liquid or solid dose manufacturing, etc.).
• Training or experience in quality tools (Kaizen, lean manufacturing, etc.).
• Located on the West Coast

PHYSICAL REQUIREMENTS:

This role requires the ability to:

• Ascend or descend ladders, stairs, ramps, and the like, using feet and legs and/or hands and arms. Body agility is emphasized.
• Stand, for sustained periods of time.
• Walk, moving on foot to accomplish tasks and to move from one work location to another.
• Communicate well, thru spoken word, conveying detailed accurate information & instructions to others.
• Hear well, perceiving sounds with or without correction, including the ability to receive information thru oral communications.
• Exert up to 10 pounds of force occasionally and/or negligible amounts of force frequently to lift, carry, push, pull or otherwise move objects.
• Have close visual acuity to perform an activity such as preparing & analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devices.

Why work at Intertek?

Intertek is a world leader in the $250 billion Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. At Intertek, we exercise our spirit of innovation, the passion of our people and our unmatched customer commitment to realize our purpose of making the world an ever better, safer, and more sustainable place for all. Learn more about Our History and What We Do .

What we have to offer:
When Working with Intertek , you can expect salary and benefit package competitively placed within the local market, including medical, dental, vision, life, disability, 401(k) with company match, tuition reimbursement and more.

Intertek is a drug-free workplace. As a condition of employment, all hires are required to pass a pre-employment drug test.

Intertek believes that Our People are our strongest tool for success. We are an Equal Opportunity Employer and do not discriminate against applicants due to veteran status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, or gender identity.

For individuals with disabilities who would like to request an accommodation, or who need assistance applying, please email hr.eeo@intertek.com or call 1-877-694-8543 (option #5) to speak with a member of the HR Department.

The base wage or salary range for this position is $90,000 to $110,000. Individual compensation packages are based on a variety of factors unique to each candidate including skill set, experience, qualifications and other job-related reasons. In addition to competitive compensation packages, Intertek employees are eligible for a variety of benefits including paid time off, paid holidays, paid parental leave, medical plan options, dental, vision, life and disability insurance, a 401(k) plan with company matching, tuition reimbursement, and more.

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#LI-JC1Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.