Quality Assurance Specialist II - External Quality

Scorpion Therapeutics; Madison (WI); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Wisconsin pay range: $70,000 - $85,000

Competitive salaries and an excellent

Job summary

Scorpion Therapeutics in Madison, WI is seeking a Quality Assurance professional to support development, clinical, and commercial programs.

You will review and approve vendor documentation, perform lot disposition, generate CoC as needed, and help maintain compliant records in a fast-paced biotech setting.

Collaborate with internal teams and external vendors, ensure adherence to GMP, GCP, and GLP, and help drive continuous improvement of QA processes.

Qualifications

• BS/BA in a scientific field (e.g., chemistry, biology, biochemistry).
• Minimum 3 years of quality assurance or similar experience in biotech/pharmaceutical development, manufacturing, or contract manufacturing.
• Working knowledge of GMP, GCP, and/or GLP; ICH and FDA guidance documents.
• Excellent interpersonal, verbal, and written communication.
• Ability to communicate professionally with external parties.
• Ability to follow company procedures, work instructions, and policies.
• Excellent attention to detail and organizational skills.
• Ability to work independently with minimal supervision and manage priorities in a fast-paced environment.

Responsibilities

• Interact with personnel companywide to obtain information needed for quality assurance support of development, clinical, and commercial programs.
• Review and approve vendor generated documentation, including executed batch records, testing records, certificates of analysis (CoA), labels, protocols, and reports.
• Collaborate with vendors on quality events and non-conformances per applicable quality agreements.
• Perform lot disposition and generate certificates of compliance (CoC) as necessary.
• Assist with preparation, update, review, and routing of Arrowhead procedural documents.
• Scan and upload executed documents to the EDMS, categorize properly, and route for verification/approval.
• Assist with QA duties as needed.

Skills

Interpersonal communication

Verbal communication

Written communication

Attention to detail

Organizational skills

Independent work

Education

BS/BA in a scientific field

Job description

Responsibilities:

• - Interact with personnel companywide to obtain information needed for quality assurance support of development, clinical, and commercial programs.
• - Review and approve vendor generated documentation, including executed batch records, testing records, certificates of analysis (CoA), labels, protocols, and reports.
• - Collaborate with vendors on quality events and non-conformances per applicable quality agreements.
• - Perform lot disposition and generate certificates of compliance (CoC) as necessary.
• - Assist with preparation, update, review, and routing of Arrowhead procedural documents.
• - Scan and upload executed documents to the EDMS, categorize properly, and route for verification/approval.
• - Assist with QA duties as needed.

Requirements:

• - BS/BA in an applicable scientific field (e.g., chemistry, biology, biochemistry).
• - Minimum 3 years of quality assurance or similar experience in biotech/pharmaceutical development, manufacturing, or contract manufacturing.
• - Working knowledge of GMP, GCP, and/or GLP; ICH and FDA guidance documents.
• - Excellent interpersonal, verbal, and written communication.
• - Ability to communicate professionally with external parties.
• - Ability to follow company procedures, work instructions, and policies.
• - Excellent attention to detail and organizational skills.
• - Ability to work independently with minimal supervision and manage priorities in a fast-paced environment.

Preferred:

• - Prior experience using an electronic document management system (regulated environment).
• - Proficient with Adobe Acrobat, Microsoft Office, and Smartsheet.

Pay/benefits:

• - Wisconsin pay range: $70,000 USD - $85,000 USD.
• - Competitive salaries and an excellent benefit package.