Job Summary
Write Standard Operating Procedures (SOPs), change controls, deviations, out of calibration (OOCAL) investigations, and training materials based on validated processes. Responsible for determining root cause, authoring and corrective actions associated with deviations and OOCALs. Design, develop, and implement customized technical documents for use across a variety of teams. Gather information about needs, objectives, functions, features, and requirements. Transform technical and scientific concepts into simple language so that average readers can easily understand. Responsible for the review of equipment calibration data.Job Description
MAJOR RESPONSIBILITIES:
-Responsible for the creation, writing and/or editing of procedures, SOPs, deviations, out of calibration (OOCAL) investigations, and change control documents.
-Responsible for coordinating deviation and OOCAL investigations. Work with subject matter experts to assign root cause and corrective actions for deviations and non-conforming material reports.
-Responsible for identifying documentation needs across maintenance, production, quality, and engineering teams. Design and manage independent projects, communicating project updates to key team members on a regular basis.
-Responsible for the review of equipment calibration data and reports.
-Responsible for overseeing documents through the quality review process, ensuring reports are approved by key subject matter experts and regulatory personnel prior to final submission.
- Organize material and complete writing assignments according to set standards regarding clarity, conciseness, style, and terminology. Edit, standardize, or make changes to material prepared by others.
MINIMUM JOB REQUIREMENTS :
Education - Bachelor’s degree
Work Experience - At least four years’ experience in Medical, Pharmaceutical, Manufacturing, or other field under regulatory compliance. Or - At least one year experience in Technical/Scientific Communication, Technical Writing, Regulatory Writing, or Medical Writing.
Knowledge / Skills / Abilities - Experience with Microsoft Excel and Microsoft Word. - Experience with Smartsheet.
PREFERRED JOB REQUIREMENTS:
Knowledge / Skills / Abilities - Knowledge of FDA GMP or GLP compliant manufacturing is a plus. - Experience with Smartsheet is a plus. - Experience with Microsoft Visio is a plus. - Experience in training, teaching, or general instructional design is a plus.
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 AnnualThe 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.
Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
