Quality Auditor - Pharmaceutical

Quality Auditor - Pharmaceutical SQA Services - 3.8 Avon, NY Job Details Contract $1,300 a day 3 days ago Qualifications Audit report preparation Audit engagement planning 5 years Writing skills ICH Q7 Supplier audits Quality assurance audits ICH guidelines Conflict management Senior level Leadership Communication skills FDA regulations Full Job Description For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We deliver these services by deploying a network of highly skilled associates based throughout the United States and in over 90 countries worldwide, ensuring rapid on-site support at your supplier locations. Our associates are expert quality assurance professionals with extensive experience and local expertise, enabling us to represent our clients on-demand and with greater speed and efficiency than our competitors. We're hiring a Pharma Quality Auditor. This is a contract opportunity in which you will perform supplier quality audits at various suppliers in the Northeast. These audits are 1-2 days long. You are given the flexibility to accept or reject these assignments according to your own availability. Key Responsibilities Perform supplier audits at various sites within your region of residence Assure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc… Respond to the Content team in a timely manner regarding edits/questions to your audit report Write audit reports in accordance with client specifications Required Qualifications 5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries Has been the lead auditor in at least 10 audits Direct audit experience to 21 CFR part 210/211 and

ISO 9001

Strong communication and writing skills Proven ability to deescalate workplace conflicts effectively Ability to adapt to new technology and software. Willingness to travel regionally Preferred Qualifications Direct audit experience to

ISO 17025, 21 CFR

part 58, IPEC, ICH Q7 and/or

ISO 13485 ISO

certifications are a plus but not mandatory

Pay Rate:

$1300 for a 2-day audit.

Includes:

Time spent preparing for the audit, traveling, performing the audit, writing the report, and responding to questions from our Content team of editors and the client until the report is finalized.

Does not include:

Following up on CAPA for any findings or reimbursement for travel expenses - expenses are reimbursed at cost with receipts per SQA travel policy. Note that SQA helps with the preparation of the audit and proofreads all audit reports.

Note:

SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status. #ZR We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.