Senior QA Auditor

Altasciences; Columbia Township (MO); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance

401(k) with Employer Match

Paid Vacation & Holidays

Telehealth Programs

Telework when applicable

Job summary

Altasciences is seeking a Senior QA Auditor to perform systematic audits of study-related activities ensuring data integrity and regulatory compliance under GLP, 21 CFR Part 58 and Part 11. The role includes leading audits, mentoring staff, and reporting findings to management.

Qualifications include a science degree, 2-3 years of related experience, GLP auditing, and preferred certifications (RQAP-GLP or ASQ-CQA). Strong MS Office skills and training in audits are required.

Qualifications

• Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience.
• 2-3 years related technical experience and/or training.
• Minimum of two years auditing in a GLP-regulated environment.
• Professional certification such as RQAP-GLP or ASQ-CQA recommended.
• Proficient with Microsoft Office Suite; on-the-job QA/audit training provided.

Responsibilities

• Audit phases of nonclinical and laboratory studies, reports and QA statements to ensure regulatory compliance.
• Act as lead auditor on studies and projects, maintain audit files and support planning/implementation.
• Provide risk-based compliance opinions and guidance; write inspection reports and communicate findings clearly.
• Identify opportunities for process improvements and support cross-departmental QA activities.
• Assist with regulatory training and QA data collection, trending and analysis.

Skills

Auditing

GLP Compliance

Quality Assurance

Regulatory Knowledge

Project Management

Education

Bachelor degree in a scientific discipline

Tools

Microsoft Office

Job description

About The Role The Senior QA Auditor is responsible for 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. The Senior QA Auditor is 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 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. Proficient 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

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’ 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
• #LI-ES1

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.

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!