200+ applicants

Company

Original Job Post

PharPoint Research, Inc. · 3 days ago

Quality Assurance Auditor

North Carolina, United States

Full-time

Onsite

Entry Level

1+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BiotechnologyHealth Care

Growth Opportunities

Hiring Manager

Cameron Bullman

Insider Connection @PharPoint Research, Inc.

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Assist with maintaining the Quality Management System (QMS) in line with regulatory requirements.

Generate and review SOPs, guidance, forms, and templates.

Conduct vendor audits and internal audits.

Assist in external audits and regulatory inspections.

Manage quality events, CAPAs, and deviations.

Participate in computer system validation and change control activities.

Interface with clients, stakeholders, and vendors.

Adhere to the company's Quality Management System and data integrity requirements.

Perform other related duties as assigned.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Quality assuranceQuality controlValidationIch guidelines clinical practiceCode of federal regulationsIndustry practicesEnglish proficiencyProblem-solvingCommunicationComputer System ValidationAdvanced DegreeTechnical Certifications

Required

Bachelor’s degree (B.A./B.S.) or equivalent in a scientific, computer, or related discipline

Minimum 1-2 years’ experience in quality assurance, quality control, and/or validation

Knowledge and understanding of ICH Guidelines for Good Clinical Practice, Title 21 of the Code of Federal Regulations, and good industry practices involving Quality

Ability to read, write, speak and understand English

Preferred

Advanced degree or technical certification(s)

Computer system validation experience

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above