Quality Assurance Specialist III

QA Specialist III                                                                                                                                  

With over 30 years of expertise, Gannet BioChem is a leading specialty CDMO specializing in the development, scaling, and manufacturing of polyethylene glycol (PEG) reagents—essential components in advanced biopharmaceutical and therapeutic products. Operating from a state-of-the-art 124,000 sq. ft. FDA-inspected facility in Huntsville, Alabama, Gannet BioChem delivers end-to-end GMP production, supporting clinical and commercial therapeutics. With a highly experienced team, flexible production capabilities, and a commitment to quality, Gannet BioChem provides reliable, innovative solutions to meet the evolving needs of the global biopharmaceutical industry. For additional information and to submit a resume, please visit GannetBioChem.com or follow us on LinkedIn.

Summary:

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. 

Qualifications:

·        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.).