updated 11/23/2022
Quality Control Associate
LATITUDE Pharmaceuticals Inc., a San Diego-based contract drug developer and manufacturer, is seeking a Quality Control Associate for LATITUDE’s Quality Control (QC) group, reporting to the QC Manager. A successful candidate should have experience with drug product manufacture and analytical testing techniques under GMP. The position is located in at LATITUDE’s facility in San Diego, California.
Essential Duties and Responsibilities:
- Follow Standard Operating Procedures (SOPs), protocols and other instructions from management to: (i) perform stability sample testing, (ii) perform release testing for raw materials and finished products, (iii) assist in the validation of analytical methods and qualification of analytical instruments.
- Perform GMP analytical testing and stability studies for drug products.
- Write/revise SOPs, test methods, protocols.
- Participate in out-of-specification (OOS) investigations and Change Control.
- Conduct peer review of data generated in QC.
- 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 inventory of laboratory consumables as well general lab cleanliness
- Other tasks and duties assigned by management
Education and/or Work Experience Requirements:
- Minimum BS degree in Chemistry or chemistry-related field
- 4+ years work-related experience in cGMP setting
- Experience with Microsoft Word, Excel, PowerPoint, as well as data acquisition software
- Hands-on knowledge/experience in HPLC, GC, FT-IR, UV-Vis, Karl Fisher, pH, viscosity, particulate matter, dissolution analysis, and/or other analytical techniques preferred
- Clean room experience with environmental monitor and aseptic process is preferred
- Experience with Agilent Open Lab is a plus
- Great attitude, work ethic, and attention to detail
- Excellent written and verbal communication skills
Salary commensurate with experience. LATITUDE Pharmaceuticals Inc. is an EOE.
Interested candidates should send their resume (cover letter optional) to: jobs@latitudepharma.com.
Quality Assistant I
LATITUDE Pharmaceuticals Inc., a San Diego-based contract drug developer and manufacturer, is seeking a Quality Assistant I for LATITUDE’s Quality group, reporting to the Director of Quality. This is a full-time, hourly position located at LATITUDE’s facility in San Diego, California.
Essential Duties and Responsibilities:
- Drive the ISO, quality, sampling, and related programs at the site, ensuring quality and alignment with applicable procedures.
- Maintain accurate records for quality and continuous improvement.
- Maintain and complete all compliance reporting obligations.
- Develop best practices and share within the quality and manufacturing areas.
- Receive materials for GMP manufacturing, coordinate testing, and release of the materials for manufacturing use. Coordinate shipping of materials, if needed.
- Maintain inventory of GMP manufacturing supplies and equipment. Participate in manufacturing activities as required.
Education and/or Work Experience Requirements:
- High School Diploma with relevant experience or Associates degree in Scientific Discipline
- Valid Driver’s License
- Ability to lift a minimum of 60 lbs.
- Ability to work weekdays and overtime, as needed
- 1- 2 years of work-related applicable experience in applicable area preferred
- Ability to prioritize work schedule
- Ability to work independently
- Ability to support others in completing assigned tasks
- Thoroughly follow policies and procedures
Salary commensurate with experience. LATITUDE Pharmaceuticals Inc. is an EOE.
Interested candidates should send their resume (cover letter optional) to: jobs@latitudepharma.com.
