Job Description
Job Summary
Medline is looking for a subject matter expert in medical device Endotoxin testing for our medical device quality control testing lab. Under general supervision, provides technical scientific skills and leadership for assigned QC microbiology functions including validation, testing, reviewing, dispositioning, analytical investigation, change management, CAPA, troubleshooting and identifying new technology to ensure departmental deliverable, goals and metrics are met.
Responsibilities: - Validate and develop microbiological methods for testing of raw materials, finished goods, and R&D samples with moderate to minimum supervision.
- Follow all procedures related to data documentation, laboratory safety, and good laboratory practices.
- Review test data, calculations, and results for accuracy and completeness.
- Use laboratory instrumentation and computer systems to collect and record data, identify malfunctions in laboratory equipment and advise supervisor or perform simple repairs.
- Initiate OOS, OOCAL and Deviation investigations under supervision.
- Continues to build knowledge of the organization, products, processes and customers.
- Uses prescribed guidelines or policies to analyze and resolve problems.
Qualifications:
- Bachelor's degree in Microbiology or related science.
- At least 2 years of experience in QC and/or R&D microbiology laboratory. Proficient in Microsoft Office and LIMS.
Preferred Qualifications
- At least 5 years of experience in a regulated medical device, pharmaceutical or biotech QC lab
- Experience in endotoxin medical device testing
- - specifically using chromogenic method
- Familiarity with bioburden testing, environmental monitoring, and sterility assurance is a plus.
- Familiarity with USP 60,61,62
- Experience with regulatory audits/inspections and documentation best practices.
- Ability to serve as a technical lead and mentor to junior staff and cross-functional teams.
- Excellent problem-solving and communication skills-both written and verbal.
- Experience writing and reviewing SOPs, protocols, deviation reports, and risk assessments.
- Comfortable interacting with regulatory agencies and representing the microbiology function during audits.
- Knowledge of R&D and/or QC Microbiology compendial test methods.
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:
$68,640.00 - $99,320.00 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 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.
Job Tags
Minimum wage, Full time, Work at office, Local area, Worldwide,