Fluxus Inc. is seeking a highly motivated Sr. Document Control Specialist with experience working in an early-stage biotech environment. This person will provide broad support to the organization from configuring the eQMS system, overseeing change management, performing document routings, filing approved documents to training resources and assisting in the development of the quality system.

Essential Duties and Responsibilities include the following (other duties may be assigned as necessary)

• Maintain controlled documents in strict compliance with company procedures, regulations and standards.
• Track, trend, and report on Document Control metrics.
• Review of records such as Lot (DHR) review and release.
• Manage and maintain process deviation log and closures.
• Communicate Document Control requirements and guidelines to cross-functional teams.
• Participate in the development of slides/data for Management Review.
• Participate in Notified Body audits, regulatory inspections or 3^rd party audits.
• Conduct documentation and process audits as appropriate.
• Perform job independently with minimal supervision.
• Accountable for decisions regarding individual quality records and makes recommendations for quality system programs.
• Provide support for regulatory filings.
• Manage external reference standards
• Maintain departmental training matrices, training plans, and training records
• Assist with internal and external audits and audit preparation activities Schedule, conduct and facilitate periodic document reviews to ensure compliance
• Drive continuous improvement of the QMS

Qualifications

• Knowledge of documentation systems, specifically new product development (protocols, reports, software, validation data, DHF), quality system (procedures, forms, quality records), and manufacturing (BOM, routers, procedures, DHRs, DMRs) documentation.
• Experience with electronic documentation systems such as Greenlight Guru, Agile, Documentum, MasterControl
• Direct experience maintaining procedures as the relate to the QSR and ISO required
• Exposure of 21 CFR part 11 and computer/Quality System software management methodology
• Strong technical capability, verbal and written communication skills and effective interpersonal skills
• Ability to multitask, prioritize and meet deadlines
• Must be able to work independently and as part of a team
• Experience in data entry, handling electronic files
• Proficiency in MS Office, access, excel, project as well as exposure to technical document source applications such as adobe Acrobat, Framemaker, Solidworks, and Illustrator
• Ability to communicate with all levels of staff and present data to management when needed.

Educations and/or Experience

• BS/BA in relevant discipline
• Experience in medical device/IVD start-up environments is preferred.
• Minimum of 5 years experience in an FDA regulated Medical Device, Biotech, or pharmaceutical organization.
• Thorough understanding and ability to implement QSR regulations (21 CFR Part 820) and ISO 13485.
• Experience as an internal auditor
• Ability to interpret analytical data.
• Strong organizational skills and attention to detail.
• Strong verbal and written communication skills.
• Technical writing skills are preferred.
• Strong interpersonal skills and ability to work as an effective team member.

About Fluxus

Fluxus Inc. is a privately held development-stage medical device company located in Sunnyvale, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.

As a member of Fluxus’ team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.