Job Summary
Responsible for maintaining and overseeing the revision control of corporate documents. This role will also be responsible for coordinating the daily/weekly/monthly workflow and reviewing documentation for the department.
Job Description
MAJOR RESPONSIBILITIES:
- Ensure that corporate documents are properly maintained, updated, and filed correctly (DMR, ECNS, reports, artwork/print plates as applicable).
- Initiate and circulate document changes for review and update.
- Assist in ensuring that all three-year reviews are completed for all procedures.
- Generate COC/COA/COT certificates when requested.
- Maintain and update monthly training reports and update training groups as needed.
- Coordinate and ensure training is completed on new/revised documents.
- Log training in Reliance for non-email training groups. -
- Distribute monthly report pertaining to deviation activity and CAPA activity. -
- Act as a Reliance Administrator for site as applicable.
- Assist with customer labeling creation and oversee artwork review and release process as it pertains to print plate and custom insert labeling as applicable.
- Assist with additional projects and department duties assigned as necessary.
ADDITIONAL RESPONSIBILITIES:
- Perform 3-year document/procedure reviews for Namic Glens Falls
- Own training groups and training assignment for Namic Glens Falls employees
- Send notifications and follow up on overdue training assignments, overdue 3-year reviews, and other document-related activities.
- Support DHR collection, retrieval, filing, scanning, archiving. Attach deviations to DHRs when applicable.
- Serve as document reviewer prior to approval process
- Process documents through ETQ/Reliance (procedure updates, Qual records, etc.)
- Review and process routine environmental reports
- Serve as backup for sterilization load release in SAP
- Coordinate document collection and organization for reviews requested by Namic Glens Falls Sister sites (i.e. P090, HNL)
- Serve as a primary coordinator and reviewer in the backroom during internal and external audits, ensuring that all documentation is organized and accurate, reviewed prior to sharing with the front room.
- Maintain and update Quality Metrics trackers, including but not limited to AAs, QDAs, and other metrics reviewed during the monthly Quality Meeting (as needed).
- Serve as backup testing coordinator for environmental monitoring (as needed).
Education:
- High School Diploma or equivalent
Work Experience:
- At least 1 years of experience in Quality or Regulatory Affairs.
Knowledge / Skills / Abilities:
- Intermediate skill level with SAP.
- Intermediate skill level in Microsoft Excel and Microsoft Office.
- Working knowledge of regulations regarding document control and GDP.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$21.25 - $30.75 Hourly
The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
