Quality Assurance Specialist

4 weeks ago


Maryland Heights, Missouri, United States Kindeva Drug Delivery Full time
Job Summary

This entry-level QA position involves performing tasks to written specifications, SOPs, cGMPs, and FDA regulations. The individual will undergo training to gain a working understanding of quality concepts and the inspection process. After training, they will be able to perform sampling and inspections without supervision, making quick calls during inspections and recognizing situations that may halt production. The role requires strong attention to detail, organizational skills, and effective communication and interpersonal skills.

Key Responsibilities

Perform sampling processes as per procedures to fulfill product specifications and requirements.
Review batch records and GMP documentation.
Observe processes, troubleshoot issues, and escalate to management as needed.
Perform line clearances and provide shift information to the lead before the next shift arrives.
Follow GMP documentation practices in manufacturing and packaging batch records.
Assist the lead as necessary and understand product status, Good Manufacturing Practice regulations, and ANSI sampling plans.

Requirements

High school diploma or equivalent required; BS in a scientific field preferred.
Less than one year of related QA or pharmaceutical industry experience.
Strong attention to detail and organizational skills.
Effective interpersonal and communication skills.
Ability to follow instructions, policies, and procedures.

Work Environment

The position requires regular onsite attendance and the ability to work effectively under strict production, time, and performance deadlines. The individual must be willing and able to work beyond regular hours, including weekends and holidays. Safety for employees and communities is a key priority for Kindeva Drug Delivery, and the company encourages vaccination. Kindeva is an Equal Opportunity/Affirmative Action Employer and does not discriminate based on protected characteristics.

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