Data Review I, Quality Control (short term assignment)

Responsibilities

• Perform timely data review with a high focus on data quality to ensure accuracy, completeness, cGMP compliance of QC test data.
• Verify data transfer, calculations and documented information such as reagent expiry, instrument calibration, logbook entries, standards, controls, etc. are present, complete and accurate.
• Verify that all analysis performed were as per test method and/or compendial methods and were in compliance with GMP requirements.
• Data review included but limited to QC testing data supporting product release, incoming material testing; stability studies, and qualification/validation/verification related studies.
• Complete training for test methods in a timely manner.
• Utilize knowledge of good documentation practices and good laboratory practices on a daily basis.
• Other duties as assigned.

Skills required

• Must be highly organized, detail oriented and able to manage multiple projects.
• Able to maintain detailed and accurate records.
• Excellent communication skills both written and oral
• Motivated and flexible to work in a dynamic group.
• Must work with a balance of both speed and accuracy.
• Capable of working independently
• Ability to remember and accurately follow detailed instructions.

Education and experience

• BS degree in scientific area or equivalent
• 0-2 years of pharmaceutical experience
• USP and GMP experience
• QA experience reviewing documentation.
• Knowledge of analytical methods and testing and related instrumentation.
• Knowledge of GMPs, safety regulations and data integrity

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times
• Must be willing to travel

Compensation

The hourly rate for this role is $30. 

Who We Are

At Ferrer we are a group of people who believe in the power of purpose. And our purpose is to make a positive impact in society and bring about change in an unjust world. We are the 24/7 activists fighting for a sustainable planet, equal opportunities for all and a healthy workplace. We reject greenwashing and empty promises - we are about action. That is why in 2022 we became a B Corp company.

Alexza Pharmaceuticals is part of Ferrer and is an R&D and Manufacturing center located in Fremont, CA. Our focus is to develop technologically advanced, forward-thinking and innovative products for our pipeline based on the Staccato One Breath Technology. We research, develop and manufacture novel, proprietary products for the acute treatment of underserved medical needs.

Why Alexza/Ferrer

• Make a positive impact in society
• Participate in volunteering activities
• Grow in a culture of trust, responsibility, and constructive feedback
• Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
• Make a real difference to the team and to yourself
• Take advantage of opportunities for development & learning
• Discover a range of benefits to support your physical, emotional and financial wellbeing