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Technical Writer I in San Diego, CA at APEX Systems

Date Posted: 1/11/2019

Job Snapshot

Job Description

Job #:  929149

Apex Systems has an opening for Technical Writer I to work onsite in the Sorrento Valley area of San Diego CA. If you are a qualified candidate for this position, please send your resume and writing samples to atbrown@apexsystems.com 

The Technical Writer I will support the Quality Assurance and Regulatory Compliance Department with Technical Writing and Document Control activities to ensure compliance to Quality System Regulations and standards such as; FDA regulations and ISO standards. 
Responsibilities:
Work in compliance with Quality Management System and Quality Policy Requirements. 
Write, rewrite, edit, proofread and format Quality System documents in accordance with established guidelines for consistency. 
Support the department in implementing and maintaining a compliant Quality System per FDA and ISO requirements.
Process document change requests and coordinating the approval of SOPs, Work Instructions and Forms. 
Provide Coordinator level support for the Agile PLM and Ensur DCS. Tasks include, but not limited to, progressing documents through the Agile PLM and Ensur workflow and provide support to workflow disturbances. 
Provide support for the transition to new QMS / implementation of the Agile PLM system.
Perform Document Control activities such as, but not limited to, document review and approval, data entry, filing, maintaining logs, processing documents, scanning documents, checking out and checking in documents and generating process trends. 
Assign document identifiers to Quality and Manufacturing document types (e.g; SOP, WI, Validation studies) and provide assistance in creating such documents in ensur. 
Assist Management with supporting functions relating to the training program (data entry, filing training forms, creation of training files). 
Minimum Qualifications: 
Must have strong organizational, interpersonal, written and verbal communication skills. 
Must be self-directed, adept at juggling multiple projects and comfortable in a fast-paced and ever-changing work environment. 
Must have an eye for detail and an aptitude for learning new systems. 
Solutions oriented with experience in improving low to moderate complexity level processes and documentation. 
Must be proficient in MS Outlook, Word, and Excel, data reporting, trending and analysis. 
Must have experience as a project coordinator or support.
Proficiency in PLM systems such as Agile PLM is a plus.
Knowledge of Medical Device regulations and associated standards, e.g. QSR’s, ISO 9001, ISO 13485 is a plus. 
Education and experience:
BA / BS (preferred) or High school diploma (required).

Evidence of the pursuit of continued education in a field involving technical writing, technical communications, or strong documentation skills, including military experience, preferred.

1-3 years of Technical Writing/Editing experience in a manufacturing or logistics environment, preferred. 
Experience with an electronic document or information management systems.
Experience with Agile PLM system, preferred. 
Experience in a production / distribution, cGMP, type environment preferred. 

 

 

 

 

 

 

 

 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178