Maintain control of critical records to support two facilities. Support document change control by updating documents (red lines) to new revisions. Issue batch records for production. Maintain critical company documents; SOP’s, Training Records, Design Files, Validations, Device History Files, etc.
Essential Job Functions:
Education, Knowledge, Skills, and Abilities:
- Build effective processes to ensure Document Control activities are conducted in a timely manner and are accurately recorded.
- Build effective system to support Document Control processes, including validation as necessary and system administration.
- Manage distribution and access to approved documents and maintain controlled documentation in multiple sites.
- Distribute electronic templates to document originators in order for proposed documents to be drafted in the correct format.
- Follow Good Documentation Practices
- Coordination of review and approval of new and revised documents in a specified timeframe.
- Ensure the Document Control rules regarding document content and formatting are enforced.
- Issue batch/lot records to production.
- Provide training to personnel to ensure effective and compliant execution of document change control.
- Organize training documentation for presentation to regulatory organizations.
- Oversees work performed by documentation clerk.
- Manages the integrity, quality, availability, revision and control of documents.
- Other duties as assigned.
- 3-5 years of relevant medical device/pharmaceutical experience.
- Experience as a system owner and / or system administrator is preferred.
- Previous work in a cGMP industry is desired.
- Computer proficiency: Lotus Notes, Microsoft Word, Excel, and Office.
- Understanding “SharePoint” is strongly preferred.
- Excellent typing skills.
- Effective oral and written communication.
- Ability to communicate, interact and work effectively with people from diverse ethnic and educational background, as well as across all levels of the organization.
We partner with Chicago's top employers and match them with top talent. We represent many of Chicago's most desirable employers in their hiring efforts. They turn to Momentum for our industry specific expertise and ability to match them with the industries best candidates. Our boutique approach has made us the fastest growing scientific staffing company in Chicago.
At Momentum, we work with you to develop a job search strategy that suits your unique aspirations and skills. Our recruiting approach sets us apart from other staffing agencies by gaining a greater degree of partnership with you - the candidate. We attribute our success as a company to the relationships we’ve fostered with our candidates and contractors.
Ready to be a part of the Momentum revolution? Good idea. Here are some of the top reasons to work with Momentum:
- Full Time Healthcare - When you work with Momentum you're eligible for the same healthcare packages we have. All of our healthcare plans are Affordable Care Act compliant, don't have waiting periods and avoid federal tax penalties. You’ll be able to choose between Gold, Silver and Bronze plans. Better yet, we cover 50% of the monthly premium. Why should you be treated like a second class employee just because you are a contractor? Crazy.
- Industry Expertise - All we do is science. Period. Our industry focus gives us a greater degree of insight into what you should expect your career decision. We're experts at getting your career to where you want it to go. We'll help you understand your career options and work with you to determine the path that suits you. Why would you want to work with an agency that only does science on the side?
- Permanent Results - Last year 94% of our contractors were converted to permanent employees. Pretty impressive huh? Getting you a permanent job is our priority as an agency. No other agency in the scientific space can boast such a high conversion rate.
- No Charge - With Momentum there are no hidden fees. We don't take any money out of your paycheck or charge a conversion fee. Our clients pay for what we do, not our employees.
- Consultative Approach - When you work with Momentum, we start by learning a lot about your career direction. Only then do we propose a path that will help you achieve your career goals. We share a lot of our industry expertise with you so that you are informed about your options.