Sterling Engineering, Inc.
https://cdn.haleymarketing.com/templates/63335/logos/square_logo.png
https://www.sterling-engineering.com
https://www.sterling-engineering.com
USD
40
48
HOUR
true
Herman Davis
Quality Documentation Coordinator
2024-12-16
2025-02-14
Employment Type:
Contract
Job Category: Technical Writer
Job Number: 40141923
Compensation: $40-48 / hour
Job Description
Title: Quality Documentation Coordinator
Location: Round Lake, IL
Location: Round Lake, IL
Hire Type: Oniste, Long-term Contract
Target Pay Rate: $45.00/hour (W2, with full employee benefits)
Overview:
Sterling has helped build careers for thousands of professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S.
As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.
Job Summary:
Seeking an experienced Quality Documentation Coordinator to work cross-functionally with multiple teams (Quality, Validation, etc.) in a highly regulated manufacturing environment to manage strict documentation processes and activities.
Job Duties:
• Collaborate with Quality, Validation, and Compliance teams to manage quality documentation processes.
• Drive the execution and documentation of Corrective and Preventive Actions (CAPAs).
• Ensure compliance with regulatory standards, including FDA, GMP, and Health Canada requirements.
• Work in a matrix-driven environment to coordinate quality initiatives across departments.
• Support the development and maintenance of documentation for manufacturing processes.
• Facilitate cross-functional communication to ensure alignment on regulatory and quality objectives.
• Collaborate with Quality, Validation, and Compliance teams to manage quality documentation processes.
• Drive the execution and documentation of Corrective and Preventive Actions (CAPAs).
• Ensure compliance with regulatory standards, including FDA, GMP, and Health Canada requirements.
• Work in a matrix-driven environment to coordinate quality initiatives across departments.
• Support the development and maintenance of documentation for manufacturing processes.
• Facilitate cross-functional communication to ensure alignment on regulatory and quality objectives.
Qualifications:
• 5+ years of experience in a highly regulated industry.
• In-depth knowledge of FDA, GMP, and international regulatory standards.
• Experience in quality documentation and CAPA processes.
• Familiarity with beta lactam antibiotics manufacturing is a plus.
• Strong interpersonal skills to collaborate with diverse teams and stakeholders.
• Proficiency in managing multiple priorities in a deadline-driven environment.
• 5+ years of experience in a highly regulated industry.
• In-depth knowledge of FDA, GMP, and international regulatory standards.
• Experience in quality documentation and CAPA processes.
• Familiarity with beta lactam antibiotics manufacturing is a plus.
• Strong interpersonal skills to collaborate with diverse teams and stakeholders.
• Proficiency in managing multiple priorities in a deadline-driven environment.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identify, national origin, disability, protected veteran status, or genetic information.
Meet Your Recruiter
Herman Davis
Technical Recruiter
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Ready to kickstart your career in the vibrant Round Lake, Illinois area? Our job listings are brimming with enticing opportunities waiting to be explored! Nestled in Lake County, Illinois, Round Lake boasts a perfect blend of small-town charm and big-city amenities. With proximity to iconic landmarks like the Chain O'Lakes State Park and the renowned Genesee Theatre, there's no shortage of recreational activities and cultural experiences here. Indulge in the local cuisine at Round Lake's charming eateries, catch a show at the state-of-the-art Round Lake Area Park District's Cultural & Civic Center, or cheer for the Chicago Bears at the nearby Soldier Field. Discover why Round Lake, IL is not just a place to work, but a place to thrive and find fulfillment in your career journey.