Irvine Pharmaceutical Services Work Values

Daily Duties at Irvine Pharmaceutical Services:

• Qualified to perform Internal Company Quality Audits • Responsible for the implementation of an in-process review system and SOP to minimize errors in the laboratory in accordance to cGMP, USP and ICH guidelines. • Work with QA for review, investigation and approval of scientific projects. • Manage different schedules simultaneously and meet project deadlines by working closely with Project Management. • Lab Approve all Certificate of Analysis in LIMS prior to reaching QA. • Trained to review HPLC, GC, IC, DSC, Method Development, Method Validation, Feasibility, and various wet chemistry techniques. • Ensure that all Quality Incident Reports, OOS and OOT’s are accurately initiated • Write/Prepare, review, audit and control Research & Development and Method- Development documents including: protocols, reports, laboratory notebooks, SOP’s, material specification and compliance • Demonstrate attention to detail and a complete understanding of cGMP’s relating to documentation requirements for the final release of analytical test data in accordance to FDA guidelines and that data meets Irvine Quality Assurance standards • Review data packets to ensure all steps have been performed and verified where applicable and that all limits and specifications have been met. • Manage group presentations by creating and formatting presentations through power point.

What they like about Irvine Pharmaceutical Services:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

cGMP, FDA, ISO 9000, Quality, Audits, Reviewer, Assurance, Supervisor, Excel, Word, Power Point, LIMS

Skills

Organized, Independent and team player, Supervisor/Coordinator/Research II/Chemist, Trained in cGMP Compliance, ISO 9001, SOP’s and Protocols, Fundamentals of Protein Chemistry, Hazardous Material and Waste, Environmental Monitoring., Kinetic LAL systems., Experience in the health science industry, customer service, retail, quality control, quality assurance, data reduction and analysis, troubleshooting and development, inventory, clerical duties, safety and housekeeping, laboratory techniques and equipment, Well organized, time management skills, interpersonal and motivational skills, able to produce thorough and accurate data, results oriented, great problem-solving skills, and excellent communication skills, Proficient in English and Italian, Basic Comprehension in Spanish, Ability to provide fellow employees and work groups with knowledge and skills necessary in achieving the requirements of current and future projects.

These are some of the questions we asked our climbers about their experiences with Irvine Pharmaceutical Services: