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Company | PL Developments |
Address | , Miami, 33172, Fl |
Employment type | FULL_TIME |
Salary | |
Expires | 2023-07-26 |
Posted at | 11 months ago |
Job Details
Description
*Please note that this position is subject to PL Development's mandatory COVID-19 vaccine policy.*
JOB QUALIFICATIONS:
- Planning and organization skills; and ability to manage multiple projects in parallel
- Excellent written and verbal communication skills, and interpersonal skills.
- Associate Degree in writing or a technical field with minimum of two (2) years of experience on similar job or Bachelor’s Degree in science from an accredited college or university
- Experience working in a Pharmaceutical, Medical Devices or regulated industry
- Demonstrated ability to work well in a fast-paced setting with excellent organizational skills.
- Computer proficiency: Word, Excel and Power Point
- Strong attention to detail
- Experience with or able to quickly learn document management software
- Able to read and understand technical and regulatory literature
- Knowledgeable in cGMP’s and FDA regulations
POSITION RESPONSIBILITIES:
- Other duties may be assigned as deemed appropriate by management.
- Organizes data and drafts protocols, methods and reports
- Prepares and optimizes templates to improve efficiency and ensure continuity of style and content for documents
- Track overdue documents, and support document owners on creating the CRNs and facilitate their approval
- Draft minor deviations and investigations as required
- Obtains necessary approvals for all types of documents
- Converts vendor and customer documents (specifications, methods, etc.) into company format
- Executes method transfer, verification and validation protocols
- Works with document owner to make appropriate revisions
PHYSICAL REQUIREMENTS:
- Complies with all Company policies and procedures, including safety rules and regulations
- Work is performed in a standard office environment
- Employees are required to wear eye protection and lab coats while in the lab
- Subject to standing, walking, bending, reaching, stooping, and lifting of objects up to 25 pounds
Qualifications
Education
Required
Associates or better in Professional Writing or related field.
Experience
Required
8 years: Experience working in a Pharmaceutical, Medical Devices or regulated industry
2 years: Associate Degree in Writing or a Technical Field
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