Moderador / Inspector Modalidad TEeletrabajo

privada; Bogotá ciudad; Presencial; COP 60.000.000 - 95.000.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Quality Assurance Auditor II to enhance clinical auditing processes and ensure regulatory compliance across GCP audits and inspections. The role emphasizes leading audits, supporting project teams, and acting as a QA expert within cross-functional groups.

Qualifications include a bachelor’s degree or higher and 2+ years of QA experience, with strong English communication and knowledge of GCP regulations.

Formación

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 2+ years QA experience in related field or equivalent.
• English level equivalent to FSI Level R/2; Spanish level R/3 is required; strong written English preferred.

Responsabilidades

• Conduct and/or lead client, internal or GCP audits and regulatory inspections as requested by senior management
• Perform directed site audits, facility, vendor and/or sub-contractor audits
• Provide GCP consultation and support to project teams and external clients
• Lead process audits and may participate as a co-auditor in more complex system audits
• Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, process improvement)
• Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter
• Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings

Conocimientos

GCP knowledge

Audit leadership

Regulatory compliance

Communication skills

Root cause analysis

Problem solving

Multi-tasking

Negotiation

Attention to detail

Educación

Bachelor's degree or equivalent

Herramientas

Microsoft Office

Maintenance management system

Army Maintenance Management System

Descripción del empleo

THIS POSITION ONLY APPLIES FOR COLOMBIAN NATIONALS

• Technical degree in aviation maintenance from an accredited civilian or military institution.
• Minimum of 10 years related aviation line-maintenance experience in the military or commercial aviation field.
• Minimum of 5 years' experience as a licensed aviation quality control inspector.
• Possess a FAA Inspection Authorization license or Colombian Aeronautica Civil equivalent.
• Must have experience as a quality control inspector in corresponding aircraft or specialty (UH-60) 5 YEARS.
• Minimum of 5 years' experience in management of aviation technical manuals and publications.

Amentum is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, religion, color, sex, gender, national origin, age, United States military veteran's status, ancestry, sexual orientation, gender identity, marital status, family structure, medical condition including genetic characteristics or information, veteran status, or mental or physical disability so long as the essential functions of the job can be performed with or without reasonable accommodation, or any other protected category under federal, state, or local law. Learn more about your rights under Federal EEO laws and supplemental language at EEO including Disability/Protected Veterans ( and Labor Laws Posters ( .

THIS POSITION ONLY APPLIES TO COLOMBIAN NATIONALS

• Technical degree in aviation maintenance from an accredited civilian or military institution.
• Minimum of 8 years related aviation line-maintenance experience in the military or commercial aviation field.
• Minimum of 4 years' experience as a licensed aviation quality control inspector.
• Possess a FAA Inspection Authorization license or Colombian Aeronautica Civil equivalent.
• Must have experience as a quality control inspector in corresponding aircraft or specialty.
• Minimum of 4 years' experience in management of aviation technical manuals and publications.
• Experience with maintenance and logistics management of AT-802, aircraft (as applicable to specific job duties) is preferred.
• Knowledge of Microsoft Office and an automated maintenance management system is required. Experience with the Army Maintenance Management System is preferred.
• English language ability equivalent to the Foreign Service Institute Level R/2. Spanish language ability equivalent to the Foreign Service Institute Level R/3, S/3 is required. Strong written English skills are preferred.
• Knowledge of Colombian Aeronautica Civil, U.S. FAA, and U.S. military maintenance regulations is required.
• Knowledge of Colombian safety standards and procedures is required.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as Quality Assurance Auditor II - And enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.

What You'll Do:

• Conduct and/or lead a variety of client, internal or GCP audits and regulatory inspections as requested by senior management
• Perform directed site audits, facility, vendor and/or sub-contractor audits
• Provide GCP consultation and support to project teams and external clients
• Lead process audits and may participate as a co-auditor in more complex system audits
• Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
• Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter
• Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years').

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Thorough knowledge of GCP and appropriate regional research regulations and guidelines
• Demonstrated proficiency and led a range of project based or internal GCP audits and vendor audits to high standards required by management
• Excellent oral and written communication skills
• Strong problem solving, risk assessment and impact analysis abilities
• Solid experience in root cause analysis
• Above average negotiation and conflict management skills
• Flexible and able to multi-task and prioritize competing demands/work load
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Working Conditions and Environment:

• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience - and where your contributions truly make a difference.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.