远程 GMP 审计员

GMP Auditor - Remote
Intertek, a leading provider of quality and safety solutions to many of the world’s top-recognized brands and companies, is actively seeking a Pharma, Dietary Supplement and Cosmetic GMP Auditor to join our Remote Business Assurance team. This is a fantastic opportunity to grow a versatile career in GMP Auditing
Intertek's Business Assurance team goes beyond testing, inspection and certification to look at the underlying elements that make a company and its products successful. Our assurance solutions provide confidence and total peace of mind that a client's operating procedures, systems and people are functioning properly to provide a competitive advantage in the marketplace. Intertek is continually innovating and evolving to reduce risk for consumers, brands and organizations in every sector and industry around the world. We go beyond Testing, Inspection and Certification of products: we are a Total Quality Assurance Provider to industries worldwide. Our Purpose: Bringing quality, safety, and sustainability to life.
What are we looking for?
This is a full-time position, with the person primarily responsible for performing GMP compliance supplier audits to assure that client’s products have been manufactured, tested, handled and stored in compliance with applicable FDA or other country specific regulations and client specific requirements. This position will travel at least 50% to 75% of the time.
Salary & Benefits Information
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, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more.
What you’ll do:

• Plan, prepare, and conduct of facility audits in support of GMP as directed.
• Create Audit Plans and Agendas, and send to site;

• Hold Opening and Closing Meetings;

• Interview and observe operations in situ.

• Assemble and coordinate the activities of the audit team.

• Interpret policies, standards, and regulations, and then evaluates potentially critical problems not covered by policies, standards, and regulations.

• Assess compliance with applicable FDA, or country specific regulations and guidelines, and/or the client’s requirements and specifications.

• Advise office immediately of any critical observations identified during audit.

• Ensure that written procedures are followed, and exercise judgment in evaluating quality systems, processes, procedures, and protocols for compliance.

• Review SOPs to ensure procedures and systems used in the regulated processes, such as manufacturing and testing, are in compliance with applicable regulations and guidelines, including documented procedures for OOS, recalls, deviations, complaints, CAPA, QA responsibilities, batch record review and batch disposition.

• Appropriately escalate any compliance issues.

• Communicate audit results to management and auditees through written audit reports.

• Draft and Submit Audit Report for internal review.

• Manage post-audit activities (e.g.: CAPA assessment and review) and follow up on any necessary corrective and preventive actions by resolving any conflicts.

• Manage and ensure all travel arrangements are in compliance with applicable travel policies.

• Maintain current knowledge of industry standards and expectations.

This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.
Minimum Requirements & Qualifications:

• Accredited Quality Auditor Certification through ASQ, ANAB, IRCA or other recognized auditor training body meeting ISO/IEC 17021 (for management system certification bodies) or ISO/IEC 17065 (for product/process certification bodies).

• A four-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.

• Minimum of two-years experience in GMP industry environment (Manufacturing, CAPA, Auditing, Complaint Review)

• Valid driver’s license and reliable driving record is required.

• Routine demands of an office-based environment.

• This is a remote position; however, applicants must reside in and be able to legally work in the United States.

Preferred Requirements & Qualifications:

• A minimum of 5 years actively participating in a GMP lead auditor role; supplier auditing experience

• Previous project management experience working in an ATIC environment is an advantage.

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 devises.

Intertek: Total Quality. Assured.
Intertek is a world leader in the Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. With passion, pace, and precision we work to exceed our customers’ expectations, while engaging with our employees to be 10X in their performance and professional growth.
Intertek is a drug-free workplace. As a condition of employment, certain positions may be required to pass a pre-employment drug test based on the type of work that will be performed.
We Value Diversity
Intertek’s network of phenomenal people are our greatest assets, and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.
For individuals with disabilities who would like to request accommodation, or who need assistance applying, please email or call 1-877-694-8543 (option #5) to speak with a member of the HR Department.
Originally posted on Himalayas