Production and Quality Lead
521 Cottonwood Dr., Suite 121 Milpitas, CA 95035
Our client is seeking a Production and Quality Lead to join a growing medical diagnostics development team.
Our Company Bio: Bayside Solutions was founded in 2001, and was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Production and Quality Lead
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Production and testing of components and assays meeting GMP regulations following the device master records for immunoassays, giant magnetoresistance (GMR) sensor assay cards, and product development materials
- Developing and maintaining efficient and effective manufacturing procedures and test methods in collaboration with product development to transfer products from R&D to production
- Tracking material inventory, receiving and fulfilling material requests, and planning production activities to maintain availability of materials
- Implementing materials handing processes to support segregation, traceability, and timely delivery.
- Documentation and record keeping following company policies and SOPs
- General lab duties such as common reagent prep, cleaning, shipping, and receiving
- Other duties as assigned
- B.S., M.S., or Ph.D. degree in biochemistry, molecular biology, chemistry or related field from an accredited university; or equivalent industry experience
- Minimum 3 years’ experience in a regulated laboratory environment with M.S., or PhD degree, and a minimum of 5 years with a B.S. degree
- Experience in a quality or regulatory related role responsible for creating and maintaining quality records
- Demonstrated deep knowledge of and adherence to GMP principles, industry practices, and standards
- Track record of accomplishments that demonstrate an ability to successfully carry out the responsibilities and duties listed above for this position
- Excellent verbal and written communication skills
- Strong interpersonal and collaboration skills enabling a positive influence on employees to achieve results in an open team environment
- Excellent document writing and editing skills; able to critically review procedures
- Expert knowledge of Microsoft Office programs (i.e. Word, Excel, PowerPoint)
- Familiarity with, or ability to learn, AssurX CATSWeb® document management system
- The Production and Quality Lead position requires an ability to frequently sit or stand and to talk and hear.
- The position involves spending extensive time at a computer keyboard writing and editing documents and completing records, as well as working at a lab bench or instrument work station.
- Frequently, the employee will be required to use hands to handle, sign, and organize paper documents, labels and forms; reach with hands and arms, and climb stairs.
- Vision abilities required include close vision, depth perception, and ability to adjust focus to read labels, instrument indicators, material IDs, etc.