Documentation Specialist/Technical Writer

MMR CONSULTING; Oceanside (CA); On-site; USD 75,000 - 105,000; Full time

Job summary

MMR Consulting, an engineering and consulting firm serving the pharmaceutical and biotechnology industries, seeks a technical writer for on-site Oceanside, CA. The candidate will work with engineers and SMEs to develop, edit and validate documents for operational readiness, ensuring GDP compliance and templated consistency.

Requirements include a BA/BS in a related field, 3+ years of regulatory/document experience within biotech/pharma, and proficiency in Veeva QualityDocs and Google tools.

Qualifications

• BA or BS in English, Biology, Chemistry, Pharmacy, Engineering or equivalent experience.
• 3+ years creating/updating documents in a technical or regulatory environment; biotech/pharma preferred.
• Advanced word processing proficiency and wide range of technical skills including Google software.
• Experience with Veeva QualityDocs, Veeva OneQMS and collaboration systems.

Responsibilities

• Work with subject matter experts to create/edit/maintain documents for Operational readiness activities.
• Create and edit content using Veeva QualityDocs and ensure GDP compliance.
• Review content for site standards in formatting, organization and terminology.
• Solve complex technical writing issues following cGMP regulations.
• Initiate and execute Veeva Planned Events and track changes.
• Navigate company documentation system across Manufacturing, Facilities/Utilities and other functions.
• Set up and maintain tracking tools and metrics; communicate status of changes.
• Facilitate cross-site discussions/ meetings/adjudications.
• Adapt documents from other sites to Oceanside OSUT templates; on-site work required.

Skills

Technical writing

Attention to detail

Strong communication

Education

BA/BS in English, Biology, Chemistry, Pharmacy, Engineering or equivalent

Tools

Veeva QualityDocs

Veeva OneQMS

Google Workspace

SmartSheets

Trello

Job description

Previous Pharmaceutical/Biotech experience is mandatory for this role

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.

MMR has offices in Canada, USA, and Asia

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in the engineering and project management of equipment, systems and facilities for life sciences facilities. This role is based in Oceanside, California. The ideal candidate must have previous Pharmaceutical experience.

Responsibilities:

• Work with subject matter experts within the company network to create/ edit/ maintain documents required for Operational readiness activities


• Create and edit content at all levels of complexity consistent with current formats and templates using the Veeva QualityDocs system.


• Ensure content follows all site standards such as formatting, organization, terminology, etc. Review content provided by others for compliance with GDP (Good Documentation Practices).


• Solve complex technical writing, editing, document issues following cGMP regulations.


• Initiate and execute Veeva Planned Events


• Navigation/utilization of company specific documentation system associated with Manufacturing, Facilities / Utilities and Other functions


• Setup Tracking Tool & Metrics.


• Update & Maintain Tracking tool & metrics.


• Manage, track and communicate status of changes


• Maintain a central tracking tool to reflect progress against plan and document metrics


• Facilitate discussions/ meetings/adjudications including cross-site representatives


• Work out of document templates available from other sites, as starting point to convert such documents into Oceanside site OSUT documents.


• The work shall be performed on-site.

Qualifications

• Education: BA or BS (or equivalent) in English, Biology, Chemistry, Pharmacy, Engineering or equivalent experience.


• 3+ years of previous experience with creating/ updating documents in a technical or regulatory environment is required and experience in the biotech or pharmaceutical manufacturing industry is preferred.


• Advanced word processing proficiency is required in a broad range of technical skills, including


• Advanced use of Google Software is required and knowledge of document management


• Systems (Veeva QualityDocs), quality systems (Veeva OneQMS), and collaboration systems

(SmartSheets, Trello) is beneficial.

• Ability to write technical documents and training, with attention to detail and consistency, especially with respect to style, format, and layout for visual design simplicity.


• Strong work ethic with drive to complete tasks on time while never compromising safety or quality.


• Dependable/ reliable with excellent communication skills.


• This is an on-site role with opportunity for some flexible working exceptions.

As part of our recruitment process, we may use technology-assisted tools, including AI-enabled systems, to support application review and candidate evaluation. Hiring decisions are made with human oversight and consideration.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.