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Gannet BioChem · 15 hours ago

Quality Assurance Specialist II (Operations) - (2026-009-104)

Huntsville, AL

Full-time

Onsite

Mid Level

3+ years exp

Gannet BioChem is seeking a Quality Assurance Specialist II to join their team in Huntsville, AL. The role involves ensuring compliance with quality standards and conducting reviews of manufacturing and packaging processes, while also participating in regulatory inspections and quality improvement initiatives.

BiopharmaChemicalManufacturing

Responsibilities

Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors

Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions

Normally receives no instructions on routine work, general instructions on new assignments

Participates in the disposition of batches, including resolution of investigations and deviations to meet lot release time lines

Conduct manufacturing and packaging batch record review for accuracy and data integrity (ALCOA+) compliance

Performs line clearance and checks for product and packaging activities

Author, review and approve Documents in EDMS system to ensure compliance

Participate and provide analytical documentation review to support in the release of raw materials

Review CofA’s, stability data and release testing documentation in support of final product release

Compile Product Quality Reports (i.e. annual product reports, batch review summary report)

Contribute to quality improvement initiatives

Gathers and collates quality metric data

Participates in regulatory inspections by assisting in the coordination of readiness activities and inspection logistics

May participate as person-in-the-plant

Performs data audits and report review as required

Supports in quality investigations utilizing QA tools and follows up on corrective actions to closeout

Performs other duties as assigned

Qualification

GMP experienceFDA regulations knowledgeLaboratory instrumentationAnalytical documentation reviewQuality improvement initiativesOral communication skillsWritten communication skillsAttention to detailOrganizational skillsWork independently