Senior QA Auditor

CareAbout; Everett (WA); On-site; USD 80,000 - 87,000; Full time

Benefits offered by this job

Health insurance

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Job summary

Altasciences is seeking a Senior QA Auditor to conduct systematic audits of study-related activities and documents to ensure GLP compliance per 21 CFR Part 58/11 and applicable regulations. The role includes reporting findings to study leadership and mentoring junior staff.

You will lead audits across nonclinical and lab studies, perform in-life and facility audits, and maintain QA records while guiding process improvements and regulatory training. Strong QA background required.

Qualifications

• Bachelor degree or higher in a scientific discipline or equivalent combination of education and experience.
• 2-3 years of related technical experience and/or training. A minimum of two years auditing in a GLP-regulated environment.
• Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or other certification is recommended.
• Well versed with Microsoft Office Suite.
• Training needs for this position include on-the-job training in performing audits and inspections.

Responsibilities

• Audits phases of nonclinical and laboratory studies, reports, and performs related duties to ensure regulatory compliance.
• Audits all disciplines (e.g., Method Validations, Non-Clinical GLP Studies).
• Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
• Performs facility audits to ensure compliance with regulations.
• Acts as lead auditor on studies and projects.
• Maintains computerized files to support audit activities.
• Supports project planning and implementation.
• Provides risk-based compliance opinions and guidance.
• Writes and issues inspection reports and communicates findings clearly.

Skills

Auditing

Regulatory knowledge

Quality Assurance

GLP

Data analysis

Education

Bachelor's degree in scientific discipline

QA certification (RQAP-GLP or ASQ-CQA) recommended

Tools

Microsoft Office Suite

Job description

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role

As a Senior QA Auditor you will be carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements. The Senior QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management. Also responsible for building and maintaining effective working relationships throughout the organization and is responsible for mentoring/coaching lower-level staff.

What You’ll Do Here

• Audits phases of nonclinical and laboratory studies, reports, and performs related duties (e.g., issues audits and QA statements) to ensure regulatory compliance.
• Audits all disciplines (examples of disciplines include Method Validations, Non- Clinical GLP Studies).
• Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
• Performs facility audits to ensure that the facility is in compliance with regulations.
• Acts as lead auditor on studies and projects.
• Maintains computerized files to support audit activities.
• Supports project planning and implementation.
• Provides risk-based compliance opinions and guidance.
• Writes and issues inspection reports. Works with internal clients to ensure that inspection findings are clearly communicated and understood. Evaluates inspection finding responses to ensure they are written to address the findings appropriately.
• Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced.
• Identifies and communicates opportunities for process improvements based on audit and inspection observations. Participates in and guides process improvement activities in both small intradepartmental groups as well as complex and possible multi-departmental interactions.
• Maintains necessary documentation of QA records and study files.
• Notifies management of observed quality and compliance trends in the areas inspected.
• Autonomously performs SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications.
• Under supervision of a mentor/coach, performs the following tasks: interpretation of FDA, regulations; project management; regulatory guidance review; quality issue investigations; and QA data collection, trending and analysis.
• Recommends modifications in procedures to fit special needs or problems and involves manager when assistance in process improvement/resolution is necessary.
• Interprets and can train on GLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
• Carries out appropriate self-development efforts as directed.
• Assists with regulatory training of staff.

What You’ll Need to Succeed

• Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience.
• 2-3 years of related technical experience and/or training. A minimum of two years auditing in a GLP-regulated environment.
• Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality- Certified Quality Auditor) or other certification is recommended.
• Well versed with Microsoft Office Suite
• Training needs for this position include on-the-job training in performing audits and inspections, and independent reading of professional articles, journals and internal SOPs. Attendance at training seminars, regional and national meetings in Quality Assurance, regulatory affairs and validation, along with continual GLP training.

Work Authorization & Sponsorship:

Applicants must be legally authorized to work in the United States. Altasciences is unable to provide sponsorship, sponsorship transfers, or visa maintenance for this position. All applicants must possess valid work authorization that does not require employer sponsorship now or in the future.

What We Offer

The pay range estimated for this position is $80,000 - $87,000 annually. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.

Benefits

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Telework when applicable.

Altasciences' Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!