Document Control Coordinator
1000 New Horizons Way Vacaville, CA 95688
Bayside Solutions is seeking a Document Control Coordinator to be part of our client’ s team in Vacaville. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Document Control Coordinator
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Assist in preparation of documents for scanning and uploading.
- Format documents following procedure, using Adobe Acrobat, Word and Excel.
- Ensure original documents are complete and accuracy checked out/in to file location.
- Track and report status, issues and consistency.
- Proofread, check own work and check documents.
- Ensure uploaded documents are correct, complete and readable compared to the original.
- Document intake for design control documents including quality checks.
- Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
- Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
- Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
- Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
- Ensure compliance of training to PQS and job-related requirements.
- Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
- Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
- Participate in hazards analyses and design assessments and reviews.
- Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
Summary of Qualifications:
- B.S., preferably in engineering or technical field, or the equivalent.
- At least 2 (0 in JD) years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
- Experience in document control requirements for medical device development and electronic documentation system is highly desirable. Ability to read and understand SOPs and process instructions.
- Familiarity with relevant skills, tools and requirements
- Document Control: Proofreading, formatting, GDP, electronic documentation systems
- Software tools: Microsoft Word, Excel, PowerPoint, Adobe Acrobat, electronic documentation systems
- Requirements: International standards (e.g. ISO 13485), Federal compliances (e.g. CFR 820), Design controls, Drug Development process, Design History Files
- Interpersonal Skills
- Proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is very desirable.
- Excellent oral and written communication skills are required.
- Highly organized and detail oriented.