Quality Control Analyst I

Krystal Biotech•Pittsburgh, PA

About The Position

Krystal Biotech, Inc is seeking a highly motivated Quality Control Analyst who will perform complex analytical testing for the release of drug products for clinical and commercial use.

Requirements

Bachelor’s degree in life science required.
Experience in the following techniques: Mammalian Cell Culture, Plaque Titer, ELISA, qPCR, Southern Blot and Western Blot
Proficient in Microsoft Word, Excel, and PowerPoint.
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.

Nice To Haves

Environmental monitoring experience a plus but not required.

Responsibilities

Finished Product testing, stability testing, and reporting of the QC results to management.
Review analytical data generated and notification to management if data is outside the prescribed acceptance criteria or specification.
Support laboratory investigations, deviation investigations, CAPA, and CR as required by QC Management.
Initiate and complete clinical laboratory investigations as required
Participate in the execution of analytical method validation and/ or method transfer.
Support activities for Document Control and Record Retention
Facilitate material management through material purchasing, receipt, inventory, storage, and sampling.
Maintain the equipment in the QC Lab though Equipment SOPs working with QC Supervisors.
Participate in QC Projects as needed and as instructed.
Participate in all Global Audits as required
Responsible for maintaining all QC Lab spaces in an Audit ready state
Other duties as assigned