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:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

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: