Adare Pharma Solutions is Hiring a QC Auditor II Near Vandalia, OH
Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery! Join our mission at Adare ! What can Adare offer you?
We are seeking to hire a Quality Control Auditor II to join our Quality Control team... If any of the below describes you, we would love to meet you! Job Summary The QC Auditor II is responsible for ensuring QC compliance to GMPs by auditing laboratory documentation regarding physical and chemical testing for intermediates and finished products for commercial release and stability testing. They perform more complex method changes and be the owner for certain project related functions. Responsibilities And Learning Opportunities
Be able to perform responsibilities of the QC Auditor I position
Audit Quality Control (QC) laboratory data for correctness, completeness, and compliance with cGMPs and the company's internal quality standards
Follow-up with Quality Assurance and QC staff to facilitate any corrections to data as required
As part of the QC stability program, audit laboratory stability data and coordinate with the Stability Coordinator to manage the QC stability testing schedule
Review and recommend changes to methods under review for approval and also process validation protocols and reports
Revise QC documents as required to maintain cGMP compliance (i.e: SOPs, Test Methods/Test Sheets, CoAs) and coordinate approval through the document management system
Participate in Regulatory and Customer audits and complete follow-up actions as required
Develop and implement Corrective and Preventative Actions (CAPA) steps based on OOS/NCIR/Complaint investigation outcomes
Release quality orders in the ERP system in compliance with all approved specifications
Compile data and tabulate Product Quality Report (PQR) information for management decision making
Provide chemistry and QC system expertise to support investigations regarding customer complaints
Author Lab Investigations as SME with the support of management
Manage the QC Reserve Sample system including inventory of controlled substances
Recognize Out of Specification results, Out of Trend results and deviations to approved internal quality standards. Partner with QA to develop new acceptance criteria as required
Evaluate results of HPLC, GC, UV, IR, IC and wet chemistry techniques as applicable to a pharmaceutical laboratory environment
Uphold all Company policies, including but not limited to, the Adare Code of Conduct and the Professional Conduct Policy, Data Integrity Policy, and Anti-Harassment Policy
Attend work on a regular and predictable basis
Complete assigned tasks in a safe manner and in a constant state of alertness
Work cooperatively with managers, supervisors, coworkers, customers and the public
Requirements
BS/BA degree in Chemistry or related field
3-5 years of experience in QC, Auditor experience preferred
Familiar with Quality Management Systems, Veeva a plus
Shows advanced knowledge and the ability to evaluate results of HPLC, GC, UV, IR and wet chemistry techniques as applicable to a pharmaceutical laboratory environment
Has a thorough understanding of cGMP documentation requirements
Excellent interpersonal written and oral communication skills
Proficient in Microsoft Office including advanced skills in Excel and Word.
Ability to thrive in a dynamic and fast-paced environment
Able to prioritize duties and manage multiple projects with minimal supervision
Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision
Exceptional attention to detail and excellent organizational skills
Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. PRINCIPALS ONLY NO AGENCIES OR THIRD PARTIES Benefits