Company: Gator Bio
Location: Palo Alto
Posted on: February 25, 2021
Gator Bio, the leading developer and manufacturer of Next
Generation Bio-Layer Interferometry (BLI) biosensor technology and
services utilized by life science researchers within the biopharma,
drug discovery, pharmaceuticals and biotherapeutics. Headquartered
in Palo Alto, CA, we provide BLI label-free solutions involving
instrumentation and consumables utilized for measuring real-time
biomolecular interactions. General applications include
quantitation, kinetic analysis, and epitope binning.
Gator Bio is looking for an experienced Quality Assurance Manager
to lead the GMP compliance of QC, Manufacturing and Product
Development. ResponsibilitiesCreate, implement, and manage a GMP
Equipment Control Program, including:
- Identify all in-house GMP equipment and enter in Excel
spreadsheet tracking system;
- Installation and Operational Qualification status and
compliance by arranging for contract qualification where
- Calibration status and compliance by arranging for contract
calibration where necessary;
- Equipment control monitoring systems;
- Equipment file documentation;Create, implement, and manage a
GMP Material Control Program, including:
- Identify GMP materials requiring control;
- Part numbering;
- Specification development;
- Incoming receipt, inspection, control, and release
- Lot status change process and status labeling;
- Inventory tracking and material dispensing;
- Shipping controls;
- Material file documentation;Create, implement, and manage a
Supplier Management Program, Including:
- Identify all GMP and other supplier types requiring control and
- Qualify all suppliers
- Initiate and drive supplier surveillanceEnforcement of GMP
understanding and compliance related to equipment, material control
and supplier management & some SOP preparationQualifications
- BS or MS in biology, chemistry, biochemistry, or other related
- At least 5 years' experience working in a GMP QA operations
environment with experience in GMP equipment programs, GMP material
control programs and supplier management systems a must.
- Must have in depth knowledge of FDA GMP regulation related to
- High level of integrity, flexibility, and teamwork.
- High attention to detail; excellent organizational skills;
ability to work on multiple projects.
- Ability for problem-solving and decision-making.
- Excellent interpersonal and verbal communications skills.
- Proficient in Microsoft Office Suite - Word, Excel, PowerPoint,
Keywords: Gator Bio, Palo Alto , QA Manager, Executive , Palo Alto, California
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