QA Release Technician

Responsibilities

• Samples raw materials and assigns tests in LIMS according to approved SOPs
• Coordinates disposition of the raw material prior to release for manufacturing use
• Ensures that batches are manufactured according to approved SOP’s
• Confirms batch, creates batch file, and logs the batch record
• Manages batch records that are on an investigational, at risk, or hold status
• Answers production questions and concerns regarding batch records

• High School Diploma or GED
• Minimum of two years' experience working in an FDA regulated industry
• Excellent oral and written communication skills
• Strong interpersonal skills
• Thorough understanding of equipment operation and manufacturing processes
• Demonstrated strong analytical skills
• Ability to work independently against multiple deadlines
• Thorough knowledge of SOPs
• Ability to provide clear direction and interpretation to staff
• Demonstrated understanding of and ability to apply cGMPs

Demonstrates expertise in managing batch records and ensuring compliance with approved SOPs and cGMPs in an FDA regulated environment. Possesses strong analytical and communication skills to effectively coordinate production processes and address concerns.