Quality Assurance Specialist, SF 150798

Evonik•Birmingham, AL

4d•Hybrid

About The Position

This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality management System documentation. This position will be required to review manufacturing batch production records and supporting QC data. This position may be required to review and approve validation documentation, prior to and after execution.

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.

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.