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.
- Project document coordination
- 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.