- Hold a Bachelor's degree or equivalent.
- Five year's experience working in a clinical lab setting or regulated environment.
- Design, architect, implement, and maintain the enterprise, global, site structure for document and record management in coordination with Training/Competency for the eQMS.
- Oversee document control system from draft through approval process, implementation and archive.
- Act as point of contact and administrator for the eQMS document control system and support the users.
- Seek and make recommendations to improve the Document Control System.
- Produce, monitor, and report metrics associated with the Document Control Program.
- Administrate and maintain the ticketing system used for document management.
- Provide training on document management to Site Quality teams when there is an update to the program.
- Work with the Quality Systems team on compliance and quality improvement projects.
- Respond to recommended corrective action through process revision and preparation of reports.
- Assist in writing, reviewing, and revising related policies, protocols, and procedures.
- Adhere to laboratory health and safety guidelines.
- Assist in ad hoc projects, as directed by the team lead.
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Lab Document Control Specialist - San Francisco, United States - Invitae
Description
Invitae is a leading medical genetics company trusted by millions of patients and their providers to deliver timely genetic information using digital technology. We aim to provide accurate and actionable answers to strengthen medical decision-making for individuals and their families. Invitae's genetics experts apply a rigorous approach to data and research, serving as the foundation of their mission to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people.
Our team of Quality Assurance professionals leads the implementation and maintenance of Invitae's Quality Management System and Quality Assurance Programs that support Invitae's commitment to our customers in providing high-quality laboratory services
We are looking for an experienced Document Control professional proficient in the administration of MediaLab applications; Document Control, Compliance and CE, Compass, and Personnel Documentation. As part of the Quality Assurance Team this role will also assist in supporting internal and external audits, and continuous improvement initiatives. Candidates should be able to demonstrate proficiency with MediaLab and the creation and editing of MS Office documents, as well as skilled in the use of Adobe Acrobat. Familiarity with Box and Google suite of tools is also preferred.
This role will require frequent onsite presence (2-3 days per week). Access to the San Francisco office location is required.
Minimum Qualifications:
Duties and Responsibilities:
Secondary duties:
Assist in the preparation for and participate in Regulatory and/or Biopharma inspections.
This salary range is an estimate, and the actual salary may vary based on a wide range of factors, including your skills, qualifications, experience and location. This position is eligible for benefits including but not limited to medical, dental, vision, life insurance, disability coverage, flexible paid time off, Spring Health, Carrot Fertility, participation in a 401k with company match, ESPP, and many other additional voluntary benefits. Invitae also offers generous paid leave programs so you can spend time with your new child, recover from your own illness or care for a sick family member.
California Pay Range
$91,900—$114,800 USD
Please apply even if you don't meet all of the "What you bring" requirements noted. It's rare that someone checks every single item, it's ok, we encourage you to apply anyways.
Join us
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
We truly believe a diverse workplace is crucial to our company's success and to better serve our diverse patients. Your input is especially valuable. We'd greatly appreciate it if you can take a quick moment to make your selection(s) below. Submissions will be anonymous.
You can find a detailed explanation of our privacy practices here.
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