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.