Thermo Fisher Scientific

Compliance Auditor

Thermo Fisher Scientific$69K — $104K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor of Science (B.Sc.) in Chemistry, Biology, Pharmacy, or related field.
  • Minimum 3 years of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) auditing experience in pharma/medical devices.
  • Exceptional knowledge of GMP, GLP, and compliance with HPBI/FDA standards.
  • Proficient in quality investigation tools and familiar with SFLMS.
  • Strong written and oral communication skills, with proficiency in English.

Responsibilities

  • Conduct internal GMP audits for various departments and document findings.
  • Participate in site Fit and Finish Audit activities.
  • Facilitate site preparations and execute audits for clients and regulatory inspections.
  • Assist with ongoing guidance and training of auditors, if applicable.
  • Manage Audit Observations and Audit Corrective and Preventive Actions (CAPAs).
  • Provide administrative support for compliance projects and regulatory requests.
  • Maintain a safe working environment and report potential hazards.

Benefits

  • Medical, Dental, and Vision benefits-effective Day 1.
  • Paid Time Off and Designated Paid Holidays.
  • Retirement Savings Plan.
  • Tuition Reimbursement.
Full Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Site Specific Information

Our Whitby Site specializes in for a full range ofconventional dosage formswith specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility.

To conduct internal, external and client Good Manufacturing Practices (GMP) audits.

Day in the Life:

  • Performinternal Good Manufacturing Practices audits of all departments asrequiredand prepare writtenreportsto document the findings.

  • Participate in thesite Fit and Finish Audit.

  • Facilitate site preparations andexecuteauditsfor clients and regulatoryinspectionsincludingregulatory awareness programs for each agency.

  • Assistwith ongoing guidance and training of auditors(if applicable).

  • Assistwith regulatory requests.

  • Manage Audit Observations and AuditCAPAs

  • Provide administrative support for ongoing Compliance projects.

  • Maintain a safe working environment and report potential hazards.

Keys to Success:

Education:

Bachelor of Science (B.Sc.) in Chemistry, Biology, Pharmacy, orotherrelated field

Experience:

Minimum3yearsofGood Manufacturing Practices /Good LabPracticesauditing experience in pharma/medical devices.

Experience with SAP (an asset).


Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge,Skills,and Abilities:

Exceptional Good Manufacturing Practices, GLP, and HPBI/FDA compliance knowledge.Proficiencywith the use of quality investigation tools 6A, Fishbone, etc.FamiliaritywithSFLMS.Familiarity with managing GMP regulatory requests.Detail-orientedand organized, with a high degree of accuracy and thoroughness.Excellent organizational skills and ability to prioritize in afast-pacedenvironment.Strong written and oral communication skills.Works well and efficientlywith limited supervision.Demonstrated computerproficiencywith Microsoft Office programs.Proficiencywith the English Language.

Physical Requirements:

Light physical effort and fatigue. Walks,sitsor stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typicallylocatedin acomfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes orodours, temperature extremes, loud noise, strong drafts, or bright lights.Use of Personal Protective equipment may berequiredand may include any of the following: safety glasses, safety shoes, lab coat, gloves,hair net, beard cover,safety apron,andrespiratoronoccasionally.

Excellent Benefits

  • Benefits & Total Rewards | Thermo Fisher Scientific

  • Medical, Dental, & Vision benefits-effective Day 1

  • Paid Time Off & Designated Paid Holidays

  • Retirement Savings Plan

  • Tuition Reimbursement

OTHER

  • Relocation assistance is NOT provided.

  • Must be legally authorized to work in Canada now or in the future, without sponsorship.

  • Must be able to pass a comprehensive background check.

Compensation

The estimated annualized pay range for this position in Ontario is $69,400.00 $104,050.00.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ

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