Xeris Pharmaceuticals, Inc. Quality Assurance Auditor in Chicago, Illinois
The Quality Assurance Auditor position’s primary responsibility is to support the Supplier Quality Management function by liaising with suppliers to plan, coordinate and schedule audits of Xeris’ contract manufacturing partners and suppliers domestically and internationally. This position manages and executes the internal audits of Xeris’ Quality Systems and supplier audits, as needed. Previous experience with supplier quality management, change controls, investigations, CAPA, Quality metrics, Batch Record reviews is a plus.
Supports Supplier Quality Audit activities, including:
Planning, scheduling, and coordinating supplier audits to ensure compliance with applicable US FDA cGMP regulations and industry standards.
Reporting audit findings to supplier and Xeris management.
Evaluating audit finding responses from suppliers for adequacy, including root cause determination and CAPA and tracking through to closure.
Managing and overseeing approved supplier list.
Managing and overseeing internal and external audit scheduled.
Collecting, trending, and reporting supplier quality metrics.
Reviewing product specific documentation (process validation reports, equipment validation, media fill reports, product specifications etc.) to include additional products to an already approved supplier.
Supporting on site Quality inspections of Xeris’ suppliers against audit standards (21 CFR 210, 21 CFR 211, relevant USP, Combination Product and ISO standards). This includes audits of contract manufacturers of sterile drug product and active pharmaceutical ingredients, contract test laboratories, pharmaceutical distributors, and manufacturers of primary packaging components and device constituents.
Support the Internal Audit program including writing audit plans, conducting internal audits, writing audit reports, evaluating audit finding responses and tracking through to closure.
Works in collaboration with contract manufacturing partners to obtain necessary Quality documents, complete compliance reviews and facilitate timely product release activities, as needed.
Prepares and publishes Annual Product Quality review reports.
Generates Annual Product Quality review reports for Xeris products Review product specific quality documents for new product launch assessments.
Prepares trend charts and graphs for Quality management review presentation.
Supports management during external inspections.
Provides support to other areas in quality department, including but not limited to, quality and compliance review of manufacturing batch records, change control, standard operating procedures, product complaint, CAPA, and investigations.
Remains current in regulatory trends and requirements.
Bachelor’s in science or equivalent degree.
5-7 years’ experience as an Auditor in Quality and/or Manufacturing with Pharmaceutical company or similarly regulated industry.
Background in aseptic processing and experience working in a cGMP production environment, preferably with injectables and combination products.
Previous auditing experience preferred, and ASQ and/or other accreditation is highly desirable.
In depth knowledge of cGMP.
Experience interfacing with FDA during regulatory inspections is a plus.
Microsoft Word, PowerPoint, Excel
Veeva experience preferred
Competencies: Code of Federal Regulations and cGMPs, Combination Product Regulations, Strong Written and Oral communications skills, Planning and Organizing, Teamwork, Problem Solving, Quality Management, Interpersonal skills, Attention to detail, Adaptability
Position may require periodic evening and weekend work, as necessary to fulfill obligations.
Willingness to travel domestically and internationally.
Travel up to 50%.
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
Job ID: 2021-1280
Street: 180 N LaSalle St.