Quality Assurance Specialist III (2025-004-420) Position Available In Madison, Alabama

Quality Assurance Specialist III (2025-004-420)

Gannet BioChem Huntsville, AL Job Details Full-time Estimated:

$59.5K – $87.3K a year 21 hours ago Qualifications CGMP Writing skills GMP Mid-level 3 years Bachelor’s degree Manufacturing Document management systems Communication skills Editing Full Job Description Essential Duties and Responsibilities The Quality Assurance Specialist III performs a wide variety of activities to ensure compliance with applicable GMP requirements, including: Participate and provide support in the release of raw materials, intermediates and final products. Perform manufacturing and packaging batch record and analytical data pack reviews. Assure all operations are performed in compliance with company procedures and Quality Standards. Monitor designated phases of the manufacturing operations. Works to resolve production discrepancies. Write, revise and review standard operation procedures and related manufacturing documents. Generates reports. May conduct investigations related to manufactured products. Provide support in quality investigations utilizing QA tools and follows up on corrective actions to closeout. Support various project development teams by providing quality over sight of development activities. Apply knowledge of good manufacturing practices on a daily basis. Participate in the disposition of batches, including resolution of investigations and deviations to meet lot release timelines. Conduct manufacturing and packaging batch record review. Perform line clearance and checks for product and packaging activities. Support and perform Document Control activities in order to ensure compliance within the controlled document management system both electronically and manually. Maintain batch related documentation including but not limited to issuance and maintenance of batch records, labels, logbooks, spreadsheet tracking logs. Perform Document Control Functions (i.e. scan, photocopy, distribute, file, and archive, etc. Compile Product Quality Reports (i.e. annual product reports, batch review summary report). Contribute to quality improvement initiatives. Gather and collate quality metric data. Support partner audits. Performs data audits and report review as required. Participate in regulatory inspections by assisting in the coordination of readiness activities and inspection logistics. Minimum Qualification Requirements Bachelor’s degree or related experience 3 or more years’ experience in the quality function in the pharmaceutical industry working in a GMP environment is required. The ability to apply regulatory requirements and provide basic information regarding the requirements. Awareness of inspection processes and willingness to support inspections. Excellent writing and editing skills. Ability to work independently, manage multiple priorities, and execute on goals. Excellent interpersonal communication skills. Ability to manage multiple tasks with adherence to strict timelines. Strong understanding of GMP requirements. Strong attention to detail. Experience with documentation systems is a plus (i.e., MasterControl, Veeva eQMS, etc.). Physical Requirements Must be able to pass drug screening and background check for employment consideration.