Job Summary
Job Description
The Quality Specialist – Environmental Monitoring is responsible for supporting and executing the site environmental monitoring program to ensure compliance with current Good Manufacturing Practices (cGMP). This is a 3rd shift position.
MAJOR RESPONSIBILITIES:
- Assist in the development and implementation of process, reports, data analysis, trending, and procedures within the defined area of specialization
- Collaborate with multiple groups (both internal and external) to solve complex problems and continue to ensure compliance is maintained with FDA, ISO, and internal requirements.
- Review all documentation and analysis for completeness, accuracy, and assure the product and reports meet all specifications.
- Make recommendations and decisions based off the documentation and analysis that leads to better quality standards and customer experience.
- Perform environmental monitoring of cleanrooms and controlled areas (viable air, non-viable particles, critical surface, personnel monitoring)
Education:
Work Experience:
Knowledge / Skills / Abilities:
- Experience developing ways of accomplishing goals, with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
- Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
- Experience using MS Office Suite Products (Word, Excel, PowerPoint, Outlook), with an intermediate skill in Excel.
- Experience processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise conclusions.
- Working knowledge of government and industry quality assurance standards (e.g. 21 CFR 820, ISO 13485)
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:
$67,000.00 - $101,000.00 Annual
The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. 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 a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions 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 pagehere.
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.
