Lubrizol Document Control Administrator in Franklin, Wisconsin
Location: Franklin, Wisconsin, US, 53132
Company: Lubrizol Corporation
Vesta is located in Franklin WI, a growing community of 35,000 people that is located in the Southeastern portion of Wisconsin, approximately 15 miles south of Milwaukee, WI and about 60 miles north of Chicago, Il. The Southeastern portion of Wisconsin is bordered on the east by Lake Michigan, a Great Lake that has fantastic fishing and boating opportunities. The City of Milwaukee is a diverse community with many ethnic festivals that occur almost every weekend from June until September. Starting with the last week in June until the second weekend in July, the Henry Maier Festival Park, hosts Summerfest, one of the largest outdoor music festivals, highlighted by the Marcus Amphitheater, which hosts Main Stage concerts every evening. Milwaukee is also the home to Harley Davidson, the Harley Museum and Harley Davidson Bike fest every 5 years. If you are into professional sports, Milwaukee is home to the Milwaukee Brewers, who play at Miller Park, the Milwaukee Bucks who are building a new area and the Green Bay Packers are within 2 hours driving distance from Milwaukee.
Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.
The Document Control Administrator is primarily responsible for control of Quality System documentation (initiation, change, implementation and management), product release and control of process change orders (initiation, change, implementation and management).
DESCRIPTION OF ESSENTIAL DUTIES:
- Responsible for processing, tracking and implementing Process Change Orders (PCOs).
- Responsible for processing, tracking and implementing changes to Quality Systems Documentation (Quality Manual, Standard Operating Procedures, Work Instructions, Process Guides, Forms, Formulations, Test Methods, DMRs, etc).
- Responsible for the distribution and communication of the status of all controlled documents.
- Performs final review and disposition for all controlled documents after required approvals have been received.
- 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.
- Generates certificate of compliance and analysis as required.
- Responsible for Barcode Labels management.
- Supports Customer Complaints and audits by gathering the required information.
- Other duties as assigned.
DESCRIPTION OF MARGINAL DUTIES:
- Performs documentation filing as needed.
- Observe and promote Company standards and policies on safety, quality and productivity.
HIRING GUIDELINES: (To perform job successfully, and individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required/preferred).
- Successful completion of four-years of high school, or equivalent.
- Completion of two years of college with an associate’s degree (preferred).
- Over three months up to and including twelve months of experience, or any combination of education and experience that provides equivalent knowledge, skills and abilities.
- General understanding of ISO 13485:2016
- General understanding of FDA 21 CFR Part 820.
- Ability to review Customer Drawings on Specificat
- Six Sigma Green Belt (preferred).
- Previous experience in an FDA regulated business function-Quality function is highly desired.
- Quality function experience in any industry preferred.
- Experience with common data systems (Microsoft products, QCBD and ERP).
- Excellent (written and verbal) communication and effective human interaction skills.
- Flexible to change, and possess a high degree level of integrity and “can do attitude”.
- Willing to work in a team environment and contribute to group goals
- Able to convert units of measurement and perform basic math with some light algebra.
- Ability to receive and provide instructions in a positive manner.
PHYSICAL DEMANDS: (The 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 ).
This physical demand level for this job is considered light with occasionally lifting anywhere between 10-50 pounds. Exposure to lifting more than 50 pounds is rare (if ever).
The employee may constantly be subject to static standing/walking with occasional exposure to dynamic standing/walking, floor to knuckle lift/lower, knuckle to shoulder lift/lower, shoulder to overhead lift/lower, climb or balance and reaching above shoulder. The employee will rarely (if ever) be subject to pushing/pulling, sustained bending, use foot/feet to operate machine, stop, kneel, crouch or crawl or repetitive bending or squatting.
The following vision requirements apply: close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
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).
The employee may occasionally be exposed to working near moving mechanical parts with rare (if ever) exposure to wet humid conditions, working in high precarious places, fumes or airborne particles, toxic or caustic chemicals, outdoor weather conditions, extreme cold or heat, risk of electrical shock or travel on company business. The noise level is considered moderate (business office with computer printers, light traffic).
The employee will be required to wear appropriate Personal Protective Equipment such as: safety glasses in the designated areas, hairnet/beardnet and jumpsuit when on the production floor.
The employee will constantly use a PC with Microsoft Office products, ERP system and frequently use an EQMS system.
The above statements reflect the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.
Vesta, part of Lubrizol LifeSciences, offers custom medical manufacturing services, including precision thermoplastic and silicone extrusion as well as comprehensive silicone fabrication from its ISO 13485 certified facilities. Vesta capitalizes on more than 40 years’ experience, leveraging expertise in design assistance, material selection and quality compliance to enable our customer’s success.
Vesta has served as a trusted medical device outsourcing partner for four decades, delivering innovative solutions in molding, extrusion and assembly. Our Franklin, Wisconsin location includes ISO 7 certified clean room, ISO 8 controlled environment, 116,000 ft2 (10,700 m2), 17 extruders with 12 lines, 75 molding presses and a dedicated R&D laboratory. Every one of our medical device manufacturing, assembly and support services has quality at its core. Our highly collaborative, end-to-end, medical device process validation ensures quality without sacrificing product performance</span> <p class="job-location"> <span class="jobmarkets"> <br /><strong>Nearest Major Market: </strong>Milwaukee </span> <span class="jobsegments"> <br /><strong>Job Segment: </strong> <span itemprop="industry">Document Control, Electrical, ERP, Administrative, Engineering, Quality, Customer Service, Technology </span> </span> </p> </div> <div aria-hidden="true" tabindex="-1"> <div class="applylink pull-right"> <a xml:lang="en-US" lang="en-US" class="btn btn-primary btn-large btn-lg apply dialogApplyBtn " href="/talentcommunity/apply/570977900/?locale=en_US" tabindex="-1">Apply now »</a> </div> </div> <div class="clear clearfix"></div> </div> </div>