About Lubrizol
The Lubrizol Corporation, a Berkshire Hathaway company, is committed to enabling a sustainable future. Our unmatched science unlocks immense possibilities at the molecular level, driving sustainable and measurable results to help the world Move Cleaner, Create Smarter and Live Better. Our solutions are used by people every day, improving billions of lives around the world.
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
Job Location: Victor, MT
Job Type: Full-time
Type of Role: Onsite
Join Our Thriving Team at Lubrizol as Quality Assurance Document Control
Unleash Your Potential. At Lubrizol we're transforming the medical devices industry, and 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 tea
What You'll Do:
As a Quality Assurance Document Control, you'll be at the forefront of our innovation by owning all Documentation, Training and Metric requirements within the Quality Management System. Specifically, the Quality Assurance Document Control is responsible for all documentation generated and all documentation changes and records generated as part of the Quality System and is responsible for coordinating and maintaining all employee Training Files/Records. Additional core responsibilities include, working with Executive Management to identify, create and maintain key metric data to be utilized throughout the organization for monitoring and improving quality and process operations as well as overseeing the Environmental Monitoring program.
What We're Looking For:
Issue Document Change Notification (DACN) numbers Review, Process and File all DACN files Maintain/Create (distribute and expire/obsolete documents) Quality controlled Documentation Binders Maintain Product and Customer Files Issue Part Numbers and Document Numbers Maintain Master documentation indexes and Device Master Records (DMR) Manage all Approved Documents electronic copies Archive old records (electronic and paper) Update Quality System Records Create and Manage Training Files/Records for all employees Provide training as required Create and Maintain Certification Books Create and Maintain key metrics on quality and process performance Back up for Quality Technicians Oversee Environmental Monitoring including quarterly testing, annual certification, bioburden and dose audits Other duties as assigned
Description of Marginal Duties:
Observe and promote Company standards and policies on safety, quality and productivity Understand current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in medical device and clean room environment Follow company rules as set forth in the Employee Policy handbook Demonstrate flexibility and cooperative behavior with colleagues and supervisors at all times
Skills That Make a Difference:
Successful completion of four-years of high school, or equivalent. 1+ year(s) of experience in FDA Regulated industry experience, or any combination of education and experience that provides equivalent knowledge, skills and abilities. Proficient computer knowledge, including Office products. Demonstrated excellent (written and verbal) communication and effective human interaction skills. Is flexible to change, possess a high degree of integrity, and operates with a “can do attitude”. Willing to work in a team environment and contribute to group goals. Has the ability to receive and provide instructions with a positive manner. Ability to perform basic math calculations (add, subtract, multiply, divide).
Physical Demands:
They physical demands described here are representatives of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function. The phrases “occasionally”, “frequently” and “constantly” correspond to the following definitions: “occasionally” means up to 33% of working time, “frequently” means between 34%-66% of working time, and “constantly” means 67% and more of working time. Additionally vision requirement definitions are as follows: close vision-clear vision at 20 inches or less, distance vision—clear vision at 20 feet or more, color vision-ability to identify and distinguish colors, peripheral vision-ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point, depth perception-three-dimensional vision-ability to judge distances and spatial relationships and ability to focus—ability to adjust the eye to bring an object into sharp focus. The physical demands for this job are considered light with occasional lifting between 10-25 pounds. Exposure to lifting more than 50 pounds is rare (if ever). The employee may frequently be subject to dynamic standing/walking with constant exposure to use of hands to finger/handle/touch and static standing/sitting. The employee will rarely (if ever) be subject to sustained bending, pushing/pulling, floor to knuckle lift/lower, knuckle to shoulder lift/lower, shoulder to overhead lift/lower, stoop, kneel, crouch or crawl, reach above shoulders, repetitive bending or squatting, use foot/feet to operate machine and climb/balance.
Work Environment:
The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities. An office setting is the primary environment for the Quality Assurance Document Control. The Quality Assurance Document Control may occasionally be exposed to travel, between facilities, on company business. Risk of shock, working near moving mechanical parts, wet humid conditions, working in high precarious places, fumes or airborne particles, extreme cold or heat, outdoor weather conditions, toxic or caustic chemicals is extremely rare (if ever). The noise level is considered quiet (library, private office). The Quality Assurance Document Control will be required to wear appropriate Personal Protective Equipment such as: safety glasses in the designated areas, hairnet/beard net, gloves when handling hot objects or solvents, jumpsuit, earplugs (when needed) on production floor.
Tools/Equipment/Computer Software:
The employee will constantly use PC with Microsoft Office products with occasional use of QAD (or similar ERP system), Bartender and various internet based websites
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
Ready for your next career step? Apply today and let's shape the future together!
It’s an exciting time to be part of Lubrizol. Lubrizol is not staying put. We are continually learning and evolving. Our passion delivers our success — not only for Lubrizol but for those who count on us every day: our employees, customers and communities.
We work with a relentless commitment to operate safely and responsibly, keeping safety, sustainability, ethics, and compliance at the forefront of everything we do. The well-being of our employees, customers and communities is paramount to our culture and in the way we approach our work.
As a diverse, global team, we work together to solve some of the world’s most pressing challenges. We impact everyday lives through science only Lubrizol can deliver, and we never stop pushing to do it better.
One of the founding principles of The Lubrizol Corporation more than 90 years ago was treating every employee with dignity and respect. That same commitment is only stronger today.
More than that, we are committed to providing an environment where every employee can be the best they can be, no matter their race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status or any other characteristic.