QA Specialist II

Evonik Group.; Birmingham, Northern (AL, KY); Hybrid; USD 75,000 - 105,000; Full time

Job summary

Evonik Group is seeking a QA professional to provide on-the-floor support during manufacturing campaigns for PDS Products, PDS Services, and MDS operations, ensuring cGMP compliance and proper disposition of materials.

You will review manufacturing documentation, change controls, environmental monitoring data, and room cleaning logs, and lead quality improvement initiatives using data-driven analysis to support production continuity.

Qualifications

• Bachelor's degree in Chemistry, Biology, Engineering, or a STEM field preferred; equivalent relevant experience may be substituted.
• 2–5 years of experience in pharmaceutical or medical device manufacturing, including at least 1 year in a Quality Assurance role.
• Working knowledge of FDA cGMP and/or QSR with experience supporting validation activities, including process validation.
• Strong technical, analytical, and problem-solving skills with applied statistics and quality investigations.
• Proficient in Microsoft Office with excellent attention to detail, organizational, communication, and interpersonal skills.

Responsibilities

• 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 and critical systems.
• Review environmental monitoring data to ensure cleanroom compliance and product quality.
• Review and approve change control documentation in line 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.

Skills

Statistical analysis

Problem solving

Attention to detail

Communication

Organizational skills

Education

Bachelor's degree in Chemistry, Biology, Engineering, or STEM

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

Job description

Job Descrip**RESPONSIBILITIES*** 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 while assisting with additional business-critical activities as needed.**REQUIREMENTS*** Bachelor's degree in Chemistry, Biology, Engineering, or another STEM field preferred; equivalent relevant experience may be substituted.* 2–5 years of experience in pharmaceutical or medical device manufacturing, including at least 1 year in a Quality Assurance role.* Working knowledge of FDA cGMP and/or Quality System Regulations (QSR), with 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) with excellent attention to detail, organizational, communication, and interpersonal skills.The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.