Job Title: Quality Document Supervisor
Job Location: Franklin, Wisconsin
Job Type: Full-Time
Type of Role: On-site
About Lubrizol
The Lubrizol Corporation, a Berkshire Hathaway company, is a specialty chemical company whose science delivers sustainable solutions to advance mobility, improve wellbeing and enhance modern life. Founded in 1928, Lubrizol owns and operates more than 100 manufacturing facilities, sales, and technical offices around the world and has about 8,000 employees. For more information, visit www.Lubrizol.com.
We value diversity in professional backgrounds and life experiences. By enabling a consistent, unbiased, and transparent recruitment process, Lubrizol seeks to create a positive experience for candidates so we can get to know them at their best. We recognize unique work and life situations and offer flexibility, ensuring our employees feel engaged and fulfilled in every aspect of life.
Join Our Thriving Team at Lubrizol as Quality Document Supervisor
Unleash Your Potential. At Lubrizol we're transforming the Medical Device industry. We're looking for exceptional talent to join us on this journey. If you are ready to join an international company with talent around the world, and want to make a real impact, we want you on our team.
What You'll Do:
As a Quality Document Supervisor, you'll be at the forefront of our innovation by managing the document control (initiation, change, approval, implementation, distribution, retention, and retrieval), product release, Process Change Orders (initiation, change, approval, and implementation), and customer complaints. The Quality Document Supervisor will lead Document Control Administrators.
What We're Looking For:
- Directs the activities of site Document Control personnel.
- Participating in internal and external audits and perform internal audits as assigned.
- Responsible for managing Process Change Orders (PCOs).
- Responsible for managing Quality Systems Documentation and records.
- Manages current and archived (internal and external) documents (electronic, hard copy, etc.) per Vesta’s record retention policies and procedures.
- Reviews final production documentation (paper and electronic DHRs ‐ routers, shippers, labels, etc.) as part of final product acceptance and release process.
- Responsible for Barcode Labels management.
- Responsible for Customer Complaints and ensures the complaints are addressed and closed out to meet internal and regulations requirements. Includes initiation, investigation support, validation, response to customers and providing defined metrics to management.
- Other duties as assigned.
Skills That Make a Difference:
- Successful completion of four‐years of high school diploma. Completion of two years of college with an Associate degree (preferred).
- General understanding of ISO 13485:2016.
- General understanding of FDA 21 CFR Part 820. Six Sigma Green Belt (preferred).
- 5+ years experience in an FDA regulated business function‐Quality function is highly desired.
- Quality function experience in medical device, pharmaceutical, cosmetic, or food/beverage industry preferred.
- Experience with common data systems (Microsoft products, QCBD and ERP).
- 3 yeas of prior supervisory experience (preferred).
Perks and Rewards That Inspire:
- Competitive salary with performance-based bonus plans
- 401K Match plus Age Weighted Defined Contribution
- Competitive medical, dental & vision offerings
- Health Savings Account
- Paid Holidays, Vacation, Parental Leave
- Flexible work environment
- Learn more at benefits.lubrizol.com
If you’re interested in the position, we encourage you to apply. Lubrizol is always looking for candidates who embody our cultural beliefs in everything they do. If you’re All In, Lead Decisively, Take Action, Think External, and can Be Courageous, Lubrizol could be the place for you.
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