Kelly Science & Clinical is seeking a Quality Assurance Associate in Lee's Summit, MO.

Direct Hire

Shift: Monday - Friday 8am-5pm

Compensation: based on experience

Primary Responsibilities:

• Documentation & Compliance: Initiate and review GMP documentation, maintain compliance systems, and perform inspections of GMP facilities. Ensure adherence to CFR and FDA guidelines.
• Organizational Integrity: Keep information well-organized and inspection-ready. Maintain the integrity and security of records, and audit on-site documentation.
• Regulatory Support: Assist in FDA inspections and internal audit procedures. Support the preparation, reporting, and follow-up of internal and external audits.
• Team Collaboration: Support senior staff members, assist in month-end reports, tracking, and trending. Revise existing SOPs for the QA department as needed.
• Regulatory Knowledge: Stay current with CFR and FDA guidance documents.

Responsibilities:

• Review GMP documentation, perform line clearances, and control the status of raw materials and finished products.
• Participate in internal audits, maintain inspectional readiness, and audit on-site records.
• Maintain Quality Assurance compliance systems in accordance with U.S. regulations and internal standards.
• Review documents related to GMP, GLP, and GCP activities.
• Assist in FDA inspections and internal audit procedures as appropriate.
• Prepare reports and follow up on internal and external audits.
• Support senior staff with various tasks and reports, including tracking and trending data.
• Revise SOPs for the QA department as needed.
• Stay updated with CFR and FDA guidance documents.

Background & Qualifications:

• Bachelor's degree in Chemistry or equivalent experience preferred.
• 3 years of experience in a GMP environment.
• Strong interpersonal, communication, and negotiation skills.
• Thorough understanding of scientific instrumentation and manufacturing techniques.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and other office applications.

Skills:

• Deep knowledge of cGMPs, GCPs, and GLPs and their application to various situations.
• Excellent communication and technical writing skills in English.
• Ability to work independently and as part of a team.
• Personal accountability for job performance, with a proactive approach to improving customer service.
• Ability to work efficiently and accurately to meet goals and timelines.
• Attention to detail in a fast-paced and flexible work environment.
• Familiarity with pharmaceutical equipment, utilities, and validation concepts.
• Computer literate with proficiency in Microsoft Office, including Word, Outlook, Excel, and Nitro.

Interested? Apply now!