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Document Control Manager

Location: San Jose, CA, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description

The Company

The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases >6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.

Specific Diagnostics, a bioMerieux company, has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific’s solution provides results 2 days sooner (1 day vs 3 days).

We offer an opportunity to join us at an inflection point in our commercial growth, with our first commercial product being released new venture capital funding and recognition from major customers and government agencies fueling an expansion of our staff.

The Job

Responsible for the day to day management of the Site Document Control Process to ensure quality documentation meets applicable customer, regulatory, and company requirements. Ability to understand manufacturing specifications, requirements, procedures and departmental processes. Maintains quality records including filing, scanning, preparing documents for scanning and shredding of documents per procedure.
  1. Verifies documentation accuracy and compliance to established procedures.
  2. Trains new employees and internal customers on internal processes as well as proper document archival and retrieval of records.
  3. Maintains and provides continuous quality improvement on documentation and data control practices.
  4. Regulates the change process so that only approved and validated changes are incorporated in released product documentation.
  5. Reviews and distributes documents and correspondence for review and ensures completion of approval process.
  6. Responds to emails and/or call to answer requests for information. Verifies document accuracy to established procedures.
  7. Assists in the review and approval of documentation and data control procedures.
  8. Maintains accurate filing systems.
  9. Ability the walk within the company campus to transfer documentation.
  10. Contributes to continuous quality improvement initiatives for documentation and data control practices.
  11. Supports audit activities related to documentation practices and assists in implementing corrective and preventive actions.
  12. Performs all work in compliance with company policy and within the guidelines of the Quality Management System.
  13. Sets priorities for workload and delegation of tasks.
  14. Develops, maintains, and reports on trends specific to the Document Control process.
  15. Assists with the development and implementation of Quality System policies.
  16. Oversight of the record retention program
You
Education and Experience
  1. BS and a minimum of 3 years' experience working in a regulated cGMP environment
  2. Knowledge of quality principles applicable to medical device products, including FDA QSR and ISO 13485.
  3. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
  4. Strong written communication skills and attention to detail are required.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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