QC Associate

Quality Control Associate

LATITUDE Pharmaceuticals Inc., a San Diego-based contract drug developer and manufacturer, is seeking a Quality Control Associate to be a key member of the QC group. A successful candidate should have some experience in drug product manufacturing and analytical testing techniques under GMP. This is a full-time position and will report to the Director of Quality. The position will be located in San Diego, California.

Essential Duties and Responsibilities:

• Follow Standard Operating Procedures (SOPs), protocols and other instructions from management to perform release testing for raw materials and finished products, assist in the validation of analytical methods, and qualification of analytical

• Perform GMP analytical testing for drug products.

• Perform GMP stability studies for drug

• Write/revise SOPs, test methods, protocols,

• Participate in out-of-specification (OOS) investigations and

• Conduct peer review of data generated in QC

• Maintain the inventory of laboratory consumables and clean

• Assist in routine maintenance of laboratory instrumentation including maintaining instrument qualification, coordinating and scheduling maintenance/requalification Maintain complete and accurate records of instrument service and repairs in conformance with company SOPs and policies.

• Maintain general cleanliness of the lab, including personal bench space and common use All other tasks and duties assigned by management.

Education and/or Work Experience Requirements:

• Minimum BS degree in Chemistry or chemistry-related field

• 1+ years work-related experience in cGMP setting

• Software such as Microsoft Word, Excel, PowerPoint, as well as data acquisition

• Analytical skills with hands-on knowledge/experience in HPLC, FT-IR, UV-Vis, Karl Fisher, pH, viscosity, particulate matter, dissolution analysis, and/or other analytical techniques.

• Clean room experience with environmental monitor and aseptic process is a

• Experience with Agilent Open Lab is a plus

• Great attitude, work ethic, and attention to detail

• Excellent written and verbal communication

Salary commensurate with experience. LATITUDE Pharmaceuticals Inc. is an EOE.

Interested candidates should send their resume (cover letter optional) to: