Quality Control Laboratory Analyst (Raw Materials)

Krystal Biotech • Pittsburgh, PA

2d

About The Position

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.

Requirements

• Bachelor’s degree in life sciences or equivalent.
• 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.

Nice To Haves

• Experience with pH, Osmo, Endotoxin, Appearance, customized media, cell culture, and FBS testing, preferred.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level