Quality and Manufacturing Associate
Job Summary / Contribution of Position :
Blue Life Solutions, LLC is seeking a highly motivated individual to join our team as Quality and Manufacturing Associate.
This individual will be responsible for manufacturing and / or quality control of Blue Life’s products to ensure consistent product performance under FDA, ISO13485, and other regulatory standards.
The successful Quality and Manufacturing Associate will be a self-motivated learner, willing to take on multiple job duties, and team player.
This position offers room for career growth and will be perfect for a candidate interested in pursuing a career in biotech, medical devices, and laboratory work.
This position is temp-to-hire and is based in the Blue Life Solutions Headquarters in Las Vegas, NV.
Essential Duties and Responsibilities
Quality
- Initiate and implement appropriate experiments according to the SOP to accept or reject the release of product(s) and other related product components.
- Ensure products maintain consistent performance by implementing appropriate experiments according to the SOP.
- Analyze quality control experiments results to accept or reject product release.
- Keep a clear, complete, and accurate account of all product quality control testing through the appropriate use of quality control forms and work order documentation.
- Contribute to maintaining and developing processes for improved efficiency in quality control processes.
- Write and review Quality Control SOPs
- Review related to product development, manufacturing, and testing.
- Support / participate investigations of quality incidents, non-conformances, and customer complaints, and support the identification and implementation of corrective and preventive actions.
- Assist in the advancement, implementation or enhancement of quality processes and procedures, such as change control, CAPA, and risk management.
- Support process improvement projects.
- Monitor and report on key quality metrics, trends, and improvements.
- Analyze data and generating reports on key metrics and trends to identify areas for improvement.
- Assist in ISO certification audits and customer audits.
- Support cross-functional teams to support all aspects of quality management, including documentation, testing, audit, and continuous improvement.
- Coordinate complaint management activities and Customer Feedback activities.
- Initiate, recommend, and provide training for personnel on quality or quality-related processes.
Manufacturing
- Setup and operation of the semi-automated dispensing, capping and labeling equipment.
- Documentation of processes, lot numbers, and batch records.
- Assist in monitoring inventory of supplies needed for product assembly.
- Maintenance of equipment
- Pull products from inventory and assemble components into kits and kit sub-assemblies using quality system documents.
- Label components and kits accurately, under supervision
- Manage and maintain compliance to ISO13485 requirements.
- Responsible for responding and reporting incidents to all approved markets.
- Responsible for managing product failures and appropriate corrective actions.
Education and Experience :
- A Bachelor’s Degree in a scientific or equivalent discipline
- Basic laboratory skills
- Strong analytical and problem-solving skills
- Knowledge of Microsoft Office products
- Quality assurance principles preferable
- Manufacturing experience preferable
Core Competencies :
- Team Player.
- Communication skills verbal and written.
- Attention to detail and accuracy.
- Data collection.
- Adaptability.
- Stress tolerance.
- Ongoing Scientific Reading habits.
About Blue Life Solutions, LLC :
Founded in 2021, Blue Life Solutions, LLC is a Las Vegas-based sample collection device manufacturer offering highly collaborative services to manufacture devices for the masses.
Our innovative sample collection devices have been used all over the world. Notably, to support COVID-19 testing during the global pandemic.
To provide simple, easy to use sample collection devices, our experienced team of PhD’s and scientists offer a free sample collection device manufacturing consultation.
Dedicated to scale and quality, we follow a multi-step quality assurance process for our devices. If you are passionate about straight-forward, simple, and available collection devices and working to remove healthcare barriers for life-saving diagnoses of diseases, we want to speak with you!
Compensation :
The estimated hourly range for this position is $18 - $22 per hour at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.
Equal Employment Opportunity Employer :
Blue Life Solutions welcomes candidates of all backgrounds. These include sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, gender, gender identity, gender expression, physical & mental disability, medical condition, genetic information, military and veteran status, or any other basis protected by federal, state, or local law.
Location :
Blue Life Solutions HQ, 2015 Helm St. Las Vegas, Nevada 89119