• QA Specialist
• Research Associate

Employment Type: Full-time
Job Title: Quality Assurance Specialist
Department: Quality Assurance
Reporting to: Vice President, QC/QA
Location: San Diego, California
Date: August 14, 2018

IRISYS LLC has an open position for a QA Specialist. Candidate should have working experience in cGMP pharmaceuticals manufacturing compliance with Bachelor Degree. The experience in FDA inspection or Pre-approval inspection is a plus. The responsibilities include but are not limited to:

• Executing cGMP compliance. Up-to-date with ICH & FDA cGMP guidance and knowledgeable in handling OOS, deviations, change controls and CAPA. Review investigation reports.
• Leading Quality Assurance activities including internal and external auditing and documentation of auditing; client’s qualification.
• Provide the cGMP compliance training and documentation skill and techniques quarterly/annually. And manage updated training records for pharmaceutical manufacturing employees.
• Handles line clearance and communication with manufacturing regarding cGMP compliance performance.
• Providing quality guidance; evaluating, and assessing GMP/GLP compliance during the manufacturing process in order to support eh timely release of a product and maintain a state of inspection readiness.
• Review manufacturing batch records, technical reports including method validation protocols, and stability study protocols etc. in a timely manner; maintain cGMP compliance related documents properly.
• Excellent communication skills required.

Education Requirement:
A qualified candidate for the position must have at a minimum, a Bachelor’s degree.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “QA Specialist” in the subject line of the email.

Employment Type: Full-time
Job Title: Research Associate
Department: Research & Development
Reporting to: Director of Research & Development/Scientist
Location: San Diego, California
Date: August 14, 2018

IRISYS LLC has an open position for a Research Associate. Candidate should have working experience under general direction, assisting the research investigators by performing moderately complex research and experimentation following established protocols. The responsibilities include but are not limited to:

• Sets-up and operates various scientific apparatus; sets-up and operates various equipment, centrifuges, incubators, homogenizers.
• Performs various clerical duties including entering data into the lab notebook, batch records, or computer folders.
• Assists with research projects; performs independent research; plans, designs and implements research projects; prepares and maintains reagents; performs various assays; sterilizes equipment; separates and purifies various materials and substances using such techniques as capsule or vial fillings, orders laboratory supplies; performs library research; prepares compounds; interprets experimental test data.
• Performs various editorial duties; writes, reviews and edits various materials for batch records, specifications;
• Compiles processes and analyzes data; records research procedures and results; files and maintains records; codes data for input for electronic data processing; inputs and retrieves data using computers.
• Performs other duties as assigned.

KNOWLEDGE, SKILLS, ABILITIES AND PERSONAL CHARACTERISTICS

• Knowledge of laboratory procedures, of the use and preparation of solution, chemicals, and reagents
• Verbal and written communication skills
• Interpersonal/human relation skills
• Ability to follow oral and written instructions, to tend to details, to maintain records and inventory and to operate a personal computer
• Experience with or some knowledge of pharmaceutical Research, Development and manufacturing unit processes (e.g. powder granulations, powder blending, tablet compression, encapsulation, aseptic mix and fill procedures, microencapsulation, etc.) is desirable.

Education Requirement:
A qualified candidate for the position must have at a minimum, a Bachelor’s degree.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Research Associate” in the subject line of the email.