GMP Technical Document Editor

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Diagnostic Solutions Inc is seeking a Technical Document Editor to help support our Labeling Team in San Diego, CA. This position will provide formatting and maintenance of technical documentation in support of instrument and software operator manuals, package inserts, SOPs, specifications and training materials.

Primary responsibilities for role :

• Manages labeling change requests, creates and implements templates, style guides, and documentation standards to ensure consistency and quality across all technical documentation, submits finalized documentation for review and approval from internal departments
• Execute on project management tracking and priorities by keeping internal trackers and databases up to date, partnering with stakeholders to provide and maintain accurate data, ensuring deadlines and deliverables are met on time
• Identify and inform areas for improvement to Labeling processes, styles, formats, and participate / support in execution of continuous improvement initiatives as appropriate
• Liaise with external vendors for submission of translation projects and perform translation reviews of received documentation for consistency in format and layout
• Edit and maintain technical documentation including operator manuals, package inserts, and regulatory submission documents in compliance with regulatory requirements and company standards
• Edit documents to support Labeling Development in compliance with ISO, cGMP, EU MDR and FDA guidelines, working within established formats and templates
• Represent Labeling Development on Core Teams and collaborate closely with cross-functional teams including Regulatory Affairs, Marketing, Research & Development Instruments, Product Support and Quality Assurance to understand project requirements and ensure alignment on editing timelines
• Revise documentation as requested by stakeholders
• Manage documentation, including version control, review and approvals process, generating clean and redlined drafts in accordance with established procedures
• Manage the creation, review, approval, distribution, and archival of all controlled documents within Labeling Development, including label and packaging artwork and drawings, package inserts, operator's manuals, work instructions, SOPs, forms, and quality records
• Maintain document repositories and electronic document management systems (eDMS), ensuring accurate document metadata, version control, and document history
• Collaborate in-person with cross-functional departments to mitigate operational constraints (batch record discrepancies, GDP errors
• Assist in-person demonstrations related to content of technical documents, especially for instrument and software documentation
• Commercial printing of labels and IFUs as required
• Organize and maintain department files, databases and spreadsheets
• Support and execute on Change Control processes in a timely manner
• Support on-site audits and inspections by providing documentation as required
• Stay informed about industry trends, best practices and regulatory updates related to technical editing and apply knowledge to continuous improvement initiatives

Knowledge, Skills, and Abilities

Education

Bachelors degree in a relevant field or equivalency is required

Experience

Minimum of 2 years experience in editing technical documentation

Equivalency

6+ years of direct experience in lieu of education and experience, preferably in the medical device or pharmaceutical industry

Occupational Demands

Work is performed in an office and / or a laboratory / manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

Pay Scale

The estimated pay scale for a Technical Document Editor role based in San Diego, CA, is $73,424.05 to $91,780.35. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to : Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Third Party Agency and Recruiter Notice :

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse / family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Location :  NORTH AMERICA : USA : CA-San Diego : [[cust_building]]