Quality Control Laboratory Analyst (Raw Materials)

About the role

Krystal Biotech, Inc is seeking a highly motivated Quality Control Analyst who will be responsible for in-house raw materials and product testing for the use in the manufacture of clinical and commercial drug products.

Responsibilities

• Perform cGMP material inspection for all materials utilized for drug product manufacturing.
• Perform cGMP material testing for all materials needed for further use in manufacturing process.
• Review analytical data for compliance with regulations, methods and other specifications or criteria and collaborate with management when data does not meet acceptance criteria.
• Participate in laboratory investigations, quality event investigations, protocol and report development.
• Initiate and update quality control documentation, such as SOPs, material monographs (specification and testing documents), and test methods.
• Support activities for Document Control and Record Retention.
• Implementation of USP Quality Standards and verification of USP Methods.
• Maintain equipment in the QC Lab by performing and coordinating equipment qualification, calibration, and preventive maintenance.
• Other duties as assigned.

Requirements

• Bachelor’s degree in life sciences or equivalent.
• Experience with pH, Osmo, Endotoxin, Appearance, customized media, cell culture, and FBS testing, preferred.
• Demonstrated experience in laboratory environment and ability to follow SOPs.
• A demonstrated self-starter who is highly motivated and able to address changing priorities.
• Ability to take a proactive approach on the job with the ability to work with a dynamic team.
• Excellent scientific writing, other written and oral communication skills are required.
• Proficient in Microsoft Word, Excel and PowerPoint.

Qualifications

• Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status.