Quality Assurance Specialist Position Available In St. Louis, Missouri

Job Title:

Quality Assurance Specialist Job Description The Quality Assurance Specialist plays a critical role in supporting externally manufactured pharmaceutical and biopharmaceutical products. This position involves reviewing and writing quality systems documentation while collaborating with internal and external counterparts at the Contract Manufacturing Organization (CMO) and cross-functional team members. The role also requires appropriate escalation of issues to senior management. Responsibilities Review stability reports, evaluate data, and manage records. Approve CMO documentation for batch production and review batch records, addressing discrepancies and escalating issues to management. Input and route quality agreements. Manage quality records, including deviations, change controls, and CAPAs. Monitor cold-chain transportation for both qualification and routine purposes. Conduct annual product quality review assessments and author certain sections. Write quality systems documents and work within Master Control for authoring, reviewing, routing, and approving. Maintain regular communication with internal partners to ensure timely manufacture and resolution of quality issues. Support continuous improvement projects related to quality and Quality Management Systems (QMS). Essential Skills Experience in quality assurance and knowledge of FDA regulations. Proficiency in CAPA, change control, and QMS, including deviations and change controls. Training in supplier qualification and document management systems. Preferred experience in cGMP and pharmaceutical industry practices. Ability to conduct audits and manage batch records and document control. Additional Skills & Qualifications Bachelor’s degree in a scientific discipline. Preferred 2-5 years’ experience in quality roles with increasing responsibility. Direct experience working with quality systems, including deviations, change controls, training, supplier qualification, and document management systems. Understanding of cGMP requirements for pharmaceutical manufacturing, specifically

CFR 210/211.

Experience with sterile injectable pharmaceuticals is preferred. Work Environment The position offers a hybrid work environment, requiring attendance at the Hazelwood, MO office 1 or 2 days per week as needed. The work schedule is Monday through Friday, with flexible start times between 7:00-9:00 AM and 8-hour shifts. No overtime is required.