Hiring: QA Specialist II Company: Evonik Location: Birmingham, AL Job Posted Time: 2026-09-10 17:57:02 Employment Type: Full-time Target Skills & Keywords: cGMP, Quality Assurance, Pharmaceutical Manufacturing, Medical Device Manufacturing, Quality System Regulations (QSR), FDA Compliance, Process Validation, Environmental Monitoring, Change Control, Data-Driven Analysis, Applied Statistics, Quality Investigations, Cleanroom Compliance, WFI, Batch Records, Microsoft Office Experience: - 2–5 years of experience in pharmaceutical or medical device manufacturing - At least 1 year in a Quality Assurance role Required Skills: - Perform room clearance activities before and during manufacturing campaigns to ensure cGMP compliance - Review manufacturing documentation and perform final disposition of raw materials, fill/finish components, and batch records - Review room cleaning logs and supporting documentation for GMP compliance - Review analytical data supporting site utilities, including WFI, clean steam, nitrogen, and other critical systems - Review environmental monitoring data to ensure cleanroom compliance and product quality - Review and approve change control documentation in accordance with quality system requirements - Provide on-the-floor QA support during manufacturing campaigns for PDS Products, PDS Services, and MDS operations - Provide on-call quality support to address manufacturing issues and maintain production continuity - Lead product quality and quality system improvement initiatives using data-driven analysis - Analyze quality metrics, identify improvement opportunities, and support continuous improvement projects - Working knowledge of FDA cGMP and/or Quality System Regulations (QSR) - Experience supporting validation activities, including process validation - Strong technical, analytical, and problem-solving skills, including experience with applied statistics and quality investigations - Proficient in Microsoft Office (Word, Excel, Access) - Excellent attention to detail, organizational, communication, and interpersonal skills Qualifications: - Bachelor's degree in Chemistry, Biology, Engineering, or another STEM field preferred; equivalent relevant experience may be substituted Compensation: - Not specified Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don’t miss this opportunity to join a forward-thinking team!