- Organize and coordinate execution of multiple concurrent verification and validation studies, per the approved protocols, for submission to the FDA for 510(k) clearance.
- Build a validation team capable of executing studies across multiple shifts to deliver rapid, and high quality results from a limited pool of instruments.
- Analyze data from the experiments. Document experiments in lab notebook and maintain detailed and organized records
- Contribute to writing, reviewing protocols and study reports
- Demonstrate knowledge and proficiency of procedures and regulations
- Demonstrate proficiency in performing experiments and high quality output
- Communicate complex information, orally, in writing and electronically
- Communicate material of a specialized or highly technical nature
- May train others in SOPs and other lab procedures
- Coach and mentor team members to excellence and grow their hard and soft skills to allow for advancement into new opportunities
- Build internal contacts and participate in cross functional communication for the exchange of information and collaboration including Technology Transfer, Quality Assurance and Operations
- Maintain compliance with all company policies, quality systems and procedures
- Perform other duties as requested
- Minimum Bachelor's Degree in basic biochemistry, chemistry and molecular biology labs or similar with 5 years of experience working in a biochemistry or molecular biology lab in industry and minimum 2 years of experience in performing design verification and validation studies with hand's on experience contributing to 510(k) (or similar) submissions.
- Minimum 1 year experience as a personnel manager supervising multiple employees including providing day to day direction, mentoring and reviewing performance.
- Experience with quantitative immunoassays is preferred.
- Working knowledge of GMP, ISO 13485 quality systems, design verification and validation studies, and FDA regulations preferred
-
Artiva Biotherapeutics San Diego, United States**About Artiva** · **Job Summary** · The Manager, GxP Validation, Calibration, and Engineering, is responsible for developing the Validation and Calibration functions at Artiva, which include managing consultants and contractors to support operation activities such as facility bu ...
-
IVD Validation Manager
2 weeks ago
Genalyte San Diego, United StatesHere at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for an IVD Valida ...
-
Navy Qualified Validator Manager
2 weeks ago
Data Intelligence, LLC San Diego, United StatesData Intelligence, LLC (DI) is searching for a full time Navy Qualified Validator Manager in San Diego, CA and Virginia Beach, VA. · Job Responsibilities · Responsible for overseeing Navy Qualified Validator team. · Serve as an Independent Third-Party Assessor. · Validate that al ...
-
Navy Qualified Validator Manager
1 week ago
Data Intelligence San Diego, United StatesData Intelligence, LLC (DI) is searching for a full time Navy Qualified Validator Manager in San Diego, CA and Virginia Beach, VA. · Job Responsibilities · Responsible for overseeing Navy Qualified Validator team. · Serve as an Independent Third-Party Assessor. · Validate tha ...
-
Artiva Biotherapeutics San Diego, United StatesJob Description · Job DescriptionSalary: · About Artiva · Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for pa ...
-
Data Intelligence LLC. San Diego, United StatesData Intelligence, LLC (DI) is searching for a full time Navy Qualified Validator Manager in San Diego, CA. Job Responsibilities * Responsible for overseeing Navy Qualified Validator team. * Serve as an Independent Third-Party Assessor. * Validate that all DoN IT has implemented ...
-
Lims Administrator
3 weeks ago
Neotecra, Inc San Diego, United StatesRepresentative responsibilities will include management of laboratory scientific software for analytical labs. Computer systems validation (CSV) experience is required. Experience authoring and executing CSV software validation scripts required. Experience authoring SOPs for (1) ...
-
Part-time X Ray Technician
1 week ago
Synergy Orthopedic Specialists Inc San Diego, United States Part timeIndependently performs all routine procedures, including localizations as needed. · - Uses correct anatomical positioning, including proper shielding and collimation to ensure quality radiographs. · - Selects correct technical factors to produce optimal radiographs with the lowes ...
-
Regional Portfolio Manager
1 week ago
ConAm Management Corp San Diego, United States**Regional Portfolio Manager (Chelsea - Affordable) - San Diego County, CA** · **WHO WE ARE**: · CONAM Management Corporation is part of The CONAM Group, a multi-family property investment and management firm established in 1975 that specializes in conventional and affordable hou ...
-
Quality Assurance Inspector, F-35
2 weeks ago
Lockheed Martin San Diego, United States**Job ID**: 664427BR · **Date posted**: Apr. 09, 2024 · **Program**: F-35 · **Description**:What You Will Be Doing** · This position is part of the Quality Management team supporting F-35 aircraft Interim Contractor Support and maintenance operations at MCAS Miramar CA. The posit ...
-
Sharp Healthcare San Diego, United States Full time[H.S. Diploma or Equivalent · **Hours** · **Shift Start Time**: · Variable · **Shift End Time**: · Variable · **Additional Shift Information**: · **Weekend Requirements**: · As Needed · **On-Call Required**: · No · **Hourly Pay Range (Minimum - Midpoint - Maximum)**: · $ $ $49.78 ...
-
Hospice Weekend Day Time Runner Lvn
2 weeks ago
Anchor Health San Diego, United StatesWe are a dynamic, growing hospice agency seeking a skilled hospice LVN to assist with on call visits to patients on weekend Day shift. This is a part time/Per Diem position. If you are a nurse with prior hospice experience and have a passion for end of life care, please apply. · ...
-
Business Manager
2 weeks ago
ConAm Management Corporation San Diego, United States**Business Manager (Affordable) - Zephyr | San Diego, CA** · **WHO WE ARE**: · CONAM Management Corporation is part of The CONAM Group, a multi-family property investment and management firm established in 1975 that specializes in conventional and affordable housing. We span acro ...
-
Child Counselor
2 weeks ago
US Commander, Navy Installations San Diego, United States**Duties**: · This position is that of a fully licensed and credentialed clinical counselor located within the Counseling and Advocacy Program (CAP) at the Fleet and Family Support Center (FFSC). FFSC provides an array of quality of life programs to active duty, reservists, retir ...
-
Metrology Manager
1 week ago
Eurofins USA BioPharma Services San Diego, United States**Company Description** · Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, t ...
-
Core Civic San Diego, United States**$69,056.00 per year** · At CoreCivic, our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to better the public good. We are currently seeking a **Manager, Quality Assurance, Community Corrections - Ocean View **who has a p ...
-
Quality Control Analyst I
1 week ago
Excellos, Incorporated San Diego, United StatesJOB SUMMARY · The Quality Control Analyst will be an integral part of the QC Lab startup and implementation and perform and QC testing for Excellos. The QC Analyst role requires cGMP testing according to established procedures, contributions to assay and equipment validations, da ...
-
Operations Supervisor
1 week ago
Brougham Ambulance San Diego, United StatesUnder the immediate direction of the General Manager, the Operations Supervisor, must possess excellent skills in team building, customer services, communication skills, and maintain a positive and productive work environment. The Operations Supervisor will work in conjunction wi ...
-
HR/accounting Clerk
1 week ago
Facility Services Management Inc San Diego, United States**Job Summary** · FSI is looking to hire a HR/Accounting Clerk to join our team. The HR/Accounting Clerk performs a combination of clerical tasks to support office, business and administrative operations. Will be responsible for learning all HR clerical functions while helping ou ...
-
Maintenance Technician
2 weeks ago
ConAm Management Corporation San Diego, United States**Maintenance Technician - Cypress | San Diego, CA** · **WHO WE ARE**: · CONAM Management Corporation is part of The CONAM Group, a multi-family property investment, and management firm established in 1975 that specializes in conventional and affordable housing. We span across 12 ...
IVD Validation Manager - San Diego, United States - Genalyte
Description
Job Description
Job DescriptionHere at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for an IVD Validation Manager to join our team
ABOUT THE ROLE
Genalyte is looking to hire a driven individual to join the Technology Development team as the IVD Validation Manager. This position will primarily be responsible for overseeing execution of multiple verification and validation studies by managing a team of Validation Associates. In addition, this position will aid in the design and interpretation of validation studies, and contribute to development and troubleshooting of novel IVDs. To be successful in the role, the individual must be detail-focused and have strong project management skills. The IVD Validation Manager will contribute to a collaborative workplace culture where we encourage honest and open communication and embrace agility while having fun. This is an onsite role and the individual may need to support studies on the weekends and outside of core working hours. Here at Genalyte, our team members work with a sense of urgency and with a common goal of putting patients first. We prioritize transparency and continuous process improvement to contribute to the highest level of patient care.
ESSENTIAL FUNCTIONS & RESPONSIBILITIES
These may include but are not limited to:
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
BENEFITS & STOCK OPTIONS
At Genalyte, we believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and flexible paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career.
SALARY RANGE: $100,000 - $150,000
Offer decisions and base salary depend on a variety of factors including, but not limited to, an individual's skills, qualifications, business need and experience.
Powered by JazzHR
PYHJmjluqz