Auditor II, Global GMP/GDP Audits & Compliance (Candidates local to RTP or Silver Spring ONLY)

Unither Pharmaceuticals•Silver Spring, MD

1d•$88,000 - $135,000•Hybrid

About The Position

The Auditor II is responsible for ensuring that appropriate quality systems are in place at UT sites and at approved GMP/GDP suppliers/service providers through internal auditing, qualification (auditing) and surveillance (auditing) of GMP/GDP vendors, assisting with implementation of Quality Agreements, providing support during regulatory inspections, and participating in assigned quality improvement initiatives. The role will also be responsible for communicating with other UT departments regarding vendor change notifications and/or quality events to ensure vendor manufacturing processes, vendor materials, and services continue to comply with UT and regulatory standards.

Requirements

Bachelor’s Degree in a science or engineering related field
5+ years of experience auditing and/or managing suppliers in an FDA medical device/pharmaceutical regulated industry is required
Strong working knowledge of cGMP pharmaceutical and medical device regulations and guidelines, both US (21 CFR Parts 4, 11, 210 211 and QMSR) and familiarity with appropriate ISO and ICH standards.
Must have a valid passport or the ability to obtain a passport
Strong attention to detail and commitment to seeing tasks through to completion
Experience and comfort in working both independently and as part of a multifunctional team
Proven organizational skills and strong ability to prioritize workload
Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, including upper management
Ability to effectively interact and communicate with external vendors, government personnel and internal customers
Requires strong computer skills, Microsoft Office Applications (Word, Excel, Power Point)

Nice To Haves

Master’s Degree degree in a science or engineering related field or Doctor of Philosophy (PhD) degree in a science or engineering related field
Certified Quality Auditor ASQ or ISO lead auditor certification is desirable
Regulatory Affairs Certifications (RAC)-RAPS
Experience auditing sterile manufacturing, solid dose manufacturing and biologic manufacturing operations.
Experience reviewing medical device development documents and Design History Files
Commitment and ability to handle changing priorities, stressful situations and deadlines
Working knowledge of electronic QMS systems such as SAP, Trackwise Digital, and MasterControl
Ability to interpret multi compendia

Responsibilities

Conduct initial and routine audits of quality management system elements including but not limited to manufacturing and packaging processes, facilities, distribution practices, analytical processes, technical reports and design history files.
Perform mock pre-approval inspections as needed.
Follow good auditing practices by assisting with the development of a risk-based audit schedule, creating clear and focused audit plans, preparing detailed audit reports with well-supported findings, evaluating audit responses and corrective action plans, following up on outstanding quality issues and tracking on-going compliance with cGMPs
Conduct internal audits of UT facilities and processes from the development stage through commercialization
Conduct assessments and audits of current and potential GMP/GDP CMOs and vendors to assure compliance with UT standards and current GMP and/or GDP regulations
Prepare vendor risk assessments and, where applicable, risk control plans to ensure ongoing regulatory compliance and maintenance of product and process quality. Includes review of internal and external data (e.g. supplier quality events and change notifications) to compile product and vendor quality history
Contribute to the management and oversight of the GxP Vendor List through review and approval of new material part numbers and new vendor requests
Deal effectively and diplomatically with CMOs, suppliers, service providers, and other UT departments.
Coordinate audit activities with other team members.
Participate in the investigation of quality issues related to product failures, contractor complaints, customer complaints as needed or as directed by QA Management.
Support UT development projects and facilities to ensure full cGMP compliance at product launch. Duties include participation in development teams, training UT personnel on vendor management procedures and prioritizing new vendor qualifications
Receive, assess and when appropriate disseminate Vendor Change Notifications to qualified UT personnel
Monitor and prepare reports on quality management system performance including vendor performance and internal quality system goals
Review and evaluate UT procedures and policies to assure consistency with pertinent government regulations and guidelines
Assist in the development and review of initial Agreements with GMP/GDP suppliers/service providers when required