Quality Assurance Specialist,

Evonik•Birmingham, AL

23d

About The Position

This position provides quality and technical support to production, overseeing manufacturing rooms and laboratories through review and approval of data and Quality Management System documentation. The role reviews manufacturing batch production records and supporting analytical data, as required, and may review and approve engineering, manufacturing, and validation documentation before and after execution. All company safety, health, and environmental policies, procedures, and directives must be followed while performing assigned tasks.

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.
Proficiency in Microsoft Office (Word, Excel, Access).
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.