At GenapSys we are working to power the world of healthcare and diagnostics with advanced DNA sequencing technology. Our sequencing instrument platform leverages a proprietary electrical microfluidic sequencing chip with a scalable number of detectors, enabling a wide range of applications including targeted sequencing in oncology, pharmacogenomics and genome-wide sequencing in microbiology and others. We believe in a world where every researcher has a compact, scalable, and affordable sequencer in their own lab, empowering the democratization of genetic sequencing. Our novel sequencing method is revolutionizing genomics discovery, biomedical research, healthcare, diagnostics, agriculture, and a variety of other fields.
Our team brings together an incredibly diverse and multidisciplinary set of backgrounds and skills – from electrical and mechanical engineers, physicists, chemists, microfluidic engineers, molecular biologists, bioinformaticians, mathematicians and more. It is a super exciting time to join GenapSys as we recently launched our first product which is generating a tremendous amount of interest.
As our new Sr. Doc Control Specialist, you will lead/manage/set up the Document Control function, processes and procedures.
Some key areas of impact you will have in the first year include enabling a functional Doc Control under a Quality System for medical devices, with all gaps identified and project plans in place and being implemented. Our goal is to meet ISO 13485:2016 standards, and ultimately, certification. You will report to the Head of Quality.
Ownership of documentation control processes:
- Administer/support all aspects of the PLM system
- Determine, develop and implement best-practice documentation control processes and procedures
- Develop process workflows and design of system
- Assist Engineering, Development, Manufacturing and Contract Manufacturers with the generation of new part numbers, change orders, maintenance of BOM’s, review/track RoHS compliance, creation of required product documents (safety, etc.), DHF development
- Review ECO’s for accuracy and completeness prior to release, work with initiators to clear issues.
- Point of contact for documentation with CM’s
- Ensure all components have manufacturers data sheets, drawings, etc.
- Create system for control of process tools and fixtures (creation of files, BOM’s, calibration/PM tracking)
- Provide training to PLM system users
Development of the Quality Management System:
- Develop Policies, SOPs, DOPs and templates in the QMS as appropriate..
- Provide training and track training records.
- Document the change control process: review ECO’s for accuracy and completeness prior to release, work with initiators to clear issues.
- Host external audits.
- Review submitted records for accuracy.
- Ensure all changes are accurately and completely documented.
- Follow for-fit-function principles for all changes and assign new PN as needed.
- Bachelor’s degree in engineering or business
- Exceptional interpersonal and communication skills
- Proven expert-level Document Control administrator with hands-on experience deploying, maintaining, and providing user-level support in a manufacturing environment
- Experience developing documentation processes and procedures
- Ability to communicate with technical and non-technical users
- 5-10 years experience in regulated medical device or life science industries
- Experience with related PDM systems (Solidworks, etc.)
Bonus points if:
- Are adaptable to fast-paced, dynamic work environment and shifting demands.
- Are highly collaborative, team-oriented, and an effective communicator
- Are scrappy, willing to pitch in where needed.
- Have a passion for making a difference in the world
- Have the ability to work effectively in a matrix organization.
What we offer (US based-employees)*:
- Competitive compensation and generous stock options.
- Comprehensive, industry-leading medical, dental and vision benefits for employees and dependents.
- Pre-tax savings plans for health care, child care, elder care, public transportation and parking expenses.
- 401(k) retirement plan with matching employer contribution.
- Free daily catered gourmet lunches and snacks.
- For those emergency moments - long and short term disability, life insurance (2x salary) and an employee assistance program.
- Work with driven and enthusiastic colleagues in a fast-paced and entrepreneurial environment, the opportunity to work on problems that matter in a highly collaborative environment.
GenapSys does not accept unsolicited agency resumes. Please do not forward unsolicited agency resumes to our website or to any GenapSys employee. GenapSys will not pay fees to any third party agency or firm and will not be responsible for any agency fees absent a formal agreement.
A diverse and inclusive workplace where we learn from each other is an integral part of GenapSys' culture. We actively welcome people of different backgrounds, experiences, abilities and perspectives. We are an equal opportunity employer and a great place to work. Join us and help us achieve our mission!