Quality Assurance Associate

About the role

This position is responsible for performing quality control duties such as quality inspections, reviewing batch documentation, sampling finished product and approving or rejecting batch records in accordance with company procedures, current Good Manufacturing Practices (cGMP) and applicable regulatory requirements.

Responsibilities

• Perform quality control inspections for relabeling and kitting batches.
• Verify accuracy of information listed in batch records.
• Sample finished Relabeled/Repackaged products.
• Approve/reject batch records.
• Verify package inserts during the receiving process for readability.
• Ensure Standard Operating Procedures are adhered to by all TSMs in the Relabeling/Repackaging operation.
• Alert management of any potential quality issues; recommend to management enhancements to the process.
• Work closely with Operations to ensure compliance with cGMPs.
• Issue inspection activity reports to management and others as required.
• Assist in obtaining documentation that will be submitted to regulatory bodies.
• Assist with regulatory audits and inspections.

Requirements

• Understand ISO and FDA reporting requirements and follow instruction with some guidance.
• Knowledge of Microsoft Word, Excel and Access required.
• Typically 1 or more years of related experience.
• General education, vocational training and/or on-the-job training; Bachelor’s degree preferred.

Skills

• Excellent time management skills and the ability to prioritize work
• Attention to detail and accuracy
• Customer service oriented
• Interpersonal communication skills
• Plan and arranges activities
• Good written and verbal communication skills
• Ability to maintain confidential information
• Ability to work in a team environment
• Ability to multi-task
• Capacity to work under pressure
• Proficient in MS Office

Physical demands

Typically less than 10% travel, restricted only for the purpose of continuing education. Physical demands include lifting up to 25 lbs.