Key Responsibilities
- Develop, revise, and maintain laboratory documents, including SOPs, policies, procedures, and work instructions for quality & compliance within our Labs eQMS.
- Ensure that all documents are current, properly formatted, and in compliance with CLIA and CAP regulations and other applicable standards.
- Assist in preparing and maintaining documentation for CLIA inspections, CAP accreditation processes and other regulatory audits.
- Track and report on the status of document control activities, including updates and compliance.
- Identify opportunities for process improvements in document management and control.
- Provide leadership and be a resource to staff regarding CLIA, CAP, and related regulations and best practices, including maintaining knowledge of applicable regulations and providing consultation to staff regarding regulatory compliance.
Qualifications :
Bachelor of Science degree in medical technology, laboratory sciences or scientific disciplines
Minimum 5 years of Quality Assurance experience in a lab setting or related industry required
Knowledge and application of CLIA / CAP required
Preferred Qualifications :
- Demonstrated ability to work independently, exercise good judgment, and to work collaboratively in an interdisciplinary team
- Excellent problem solving and delegation skills with demonstrated leadership ability
- Experience with ENSUR eQMS preferred
- Experience using and configuring LIS software and knowledge of LIS documentation requirements
- Knowledge of GLP preferred
- Medical device and / or invitro diagnostics industry experience is a plus
- Certification in document control or quality management (i.e. ISO 9001) is a plus but is not required
- Knowledge of GMP / ISO requirements, specifically current ISO 13485 Medical Devices.
Cargo Specialist Part-Time
As a Cargo Specialist, you'll be the cargo handling expert for everything the Army moves by land, sea, or air. You will be trained in cargo documentation, the securing of cargo, and learn how to load and unload cargo manually or by operating material handling equipment like cranes and forklifts. ...
Part-Time Purchasing Specialist
As the Purchasing Specialist, you will support our purchasing and supply chain program under the guidance of the Vice President of Commercialization, managing vendor relationships, ensuring timely and cost-effective procurement of ingredients, raw materials, and supplies, and aligning with Chew'...
Army Hazmat Decontamination Specialist Part-Time
THIS JOB REQUIRES ENLISTING/JOINING THE U.This is an entry-level position with no experience necessary!.Be the first line of defense against weapons of mass destruction.You will be responsible for defending a nation against the biggest and most powerful threats that exist.You will be trained and tru...
Recovery Specialist - WomanPlace - Part Time - Overnights
JobPosting","title":"Recovery Specialist - WomanPlace - Part Time - Overnights","datePosted":"2024-08-28T00:00:00","validThrough":null,"description":"Bay Cove Human Services' mission is to partner with people to overcome challenges and realize personal potential. Recovery Specialist - WomanPlace - P...
Part-Time Accounts Receivable Specialist
MP is seeking a detailed-oriented Accounts Receivable Specialist (15-20 Hours a week) to join our finance team on a part-time basis. Ability to meet deadlines and manage time effectively in a part-time capacity. Additionally, the specialist will work closely with our tax credit department to collect...
Part Time Trainer/Restorative Justice Specialist- K-12 and Higher Education
The Part Time Trainer/Restorative Justice Specialist- K-12 and Higher Education will also work with CRJ staff on various projects to support our ongoing work with external partners and our internal growth and development as a team. Part Time Trainer/Restorative Justice Specialist. This part time rol...
Part Time Accounts Payable Specialist
Support the Accounts Payable function for multiple entities.Enter and code invoices in Workday .Track expenses back to the appropriate entity....
Guest Service Specialist- Part Time
The Guest Service Specialist provides consistently excellent customer service to various Museum audiences as a part of the Museum's reservations and information contact center team. This position is regular, part-time, 29 hours/week, Wednesday - Friday, 8:45 am - 5:15 pm. The Guest Services Speciali...
Retail Alterations Specialist (Full-time or Part-time)
At least six (6) months prior sewing/ fitting experience in an alterations or tailoring department. ...
Sales Specialist - Sonos - Seasonal Part-time
ActionLink is seeking an enthusiastic Part Time Sales Specialist who can bring the Sonos brand to life and make every customer interaction unforgettable!. If you are well-versed in consumer technology and can easily connect with people, this is your time to shine and make an impact!. Able to stand f...