Senior Quality Auditor

Precision For Medicine; United States; On-site; USD 80,000 - 120,000; Full time

Job summary

Join a forward-thinking company as a Senior Quality Auditor, where you'll ensure compliance with regulations and support clinical projects. This role involves oversight of quality systems, conducting audits, and providing expertise to project teams. You'll have the opportunity to influence quality standards and work in a collaborative environment that values your contributions. If you're passionate about quality assurance and looking for a dynamic role in the healthcare field, this position offers a chance to make a significant impact while enjoying a comprehensive benefits package.

Benefits

Health Insurance

Retirement Savings Benefits

Life Insurance

Disability Benefits

Parental Leave

Paid Time Off

Discretionary Annual Bonus

Qualifications

• 4 years of industry experience in quality assurance or clinical research.
• Strong knowledge of GCP, ICH guidelines, and FDA regulations.

Responsibilities

• Support the Quality Management System and maintain documentation.
• Coordinate and conduct internal and external audits for compliance.

Skills

Interpersonal Skills

Problem-Solving Skills

GCP/ICH Guidelines Knowledge

FDA Regulations Knowledge

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Customer Service Skills

Collaboration Skills

Attention to Detail

Education

Bachelor’s Degree in Science or Healthcare

Tools

Electronic Clinical Trial Systems

Job description

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The Senior Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures. Responsible for providing oversight and subject matter expertise to quality and compliance activities, supporting project teams during all stages of a clinical study.

Essential functions of the job include but are not limited to:

• Support the Quality Management System including SOPs, training and CAPA
• Process and maintain documentation for controlled documents, as required
• Develop and administer training for employees and/or consultants
• Host client/sponsor audits and support regulatory inspections
• Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
• Coordinate and conduct internal audits of quality systems
• Coordinate and conduct investigator site audits
• Coordinate and conduct trial master file audits
• Participate on computer systems validation projects and systems change control process
• Provide QA consultation and support to assigned project teams internally and externally
• Support and manage reported quality issues and any associated corrective and preventive actions
• Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
• Maintains Q&C trackers, databases, metrics, and files
• Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures
• Additional tasks as required

Qualifications:

• 4 years industry experience
• Clinical research experience in non-QA role considered (e.g., clinical research associate experience)
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards

Other Required:

• Bachelor’s degree in a science, healthcare, or related field of study; c ombination of qualifications and equivalent relevant experience may be accepted as an alternative
• Availability to travel up to 25% domestically and/or internationally

Preferred:

• CRO, Pharmaceutical and/or Medical device experience
• Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)

Skills:

• Excellent interpersonal and problem-solving skills, effective verbal and written communication, compute r skills
• Strong knowledge of GCP/ICH guidelines and FDA regulations and industry standards
• Intermediate proficiency in Microsoft Word, Excel, and PowerPoint
• Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and a keen attention to detail
• Ability to work independently and in a team environment
• Ability to work with cross functional groups and management under challenging situations
• Ability to prioritize work and handle multiple and/or competing assignments
• Results oriented, accountable, motivated and flexible
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles.
• Excellent verbal and written communications skills
• Fluent in English language and for non English speaking countries, the local language of country where position is based

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range: $80,000 USD - $120,000 USD

Any data provided as a part of this application will be stored in accordance with ourPrivacy Policy.For CA applicants, please also refer to ourCA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Technology, Information and Internet

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