Quality Assurance Associate

About the role

Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manufacturing processes and documentation practices at our headquarters in Pittsburgh's South Side.

Primary Responsibilities

• Work with internal teams to obtain an understanding of the product and the documentation requirements.
• Produce high-quality documentation that meets applicable standards and is appropriate for its intended use.
• Develop expertise on FDA regulations and audit processes.
• Initiate and update GMP manufacturing associated documentation, such as clearing procedures.
• Provide oversight of daily QA functions which include review and approval of records generated by manufacturing and quality control documents.
• Provide support for updates on standard operating procedures and associated forms.
• Assist with QA efforts for site cGXP documentation related to the operation of gene therapy manufacturing.
• Ensure compliance with regulatory agencies and oversee continuous improvement of company's QA and compliance functions.

Requirements

• Minimum of a Bachelor’s Degree (Biology or related Life Science) with 3+ years of relevant quality systems experience in the biotech or pharmaceutical industry.
• Background that includes knowledge/experience in GMP, GLP, and GCP.
• Experience with FDA audits is highly preferred.
• Strong knowledge of GMP and ICH requirements.
• Must be a self-starter and capable of working with minimal oversight.
• Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately.
• Excellent oral and written communication skills.

Qualifications

• Must be a self-starter and capable of working with minimal oversight.
• Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately.
• Excellent oral and written communication skills.

Skills

• Strong knowledge of GMP and ICH requirements.

Benefits

Not specified

Pay

Not specified

Schedule

Not specified