QA Specialist II

KBI Biopharma, Inc.; Durham (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, North Carolina is looking for a qualified individual to oversee the compliance review of biopharmaceutical development GMP data. This role involves reviewing and approving release, in-process, and stability test data, as well as method qualifications, validations, and laboratory investigations.

The ideal candidate has a BS with 11+ years or MS with 8+ years in a regulated environment, along with substantial experience in QA data review, knowledge of USP, EU, and JP cGMP guidelines, and excellent analytical skills.

Qualifications

• BS with 11+ years or MS with 8+ years in a CGMP regulated environment.
• Experience in QA review of analytical data and method validations.
• Ability to interpret regulatory guidelines and write reports.

Responsibilities

• Perform compliance review on release, in‑process, and stability data.
• Review and approve method qualifications and validations.
• Conduct reviews on deviations and laboratory investigations.

Skills

Quality Assurance review

Data analysis

Regulatory guidelines knowledge

Problem-solving

Basic math and statistics

Education

BS with 11+ years experience or MS with 8+ years experience

Tools

Microsoft Word

Microsoft Excel

Database software

Job description

Job Summary

This position is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in- process, and stability test data. The role also reviews and approves method qualifications and validations, as well as laboratory investigations and deviations associated with the biopharmaceutical development department.

Responsibilities

• Perform compliance review on release, in‑process, and stability data.
• Review and approve method qualifications and validations.
• Review and approve deviations and laboratory investigations.

Minimum Requirements

• BS with 11+ years experience or MS with 8+ years experience in a CGMP regulated environment within biopharmaceuticals or equivalent.
• Experience in QA review of analytical data (release, in‑process, and stability).
• Experience in reviewing method qualifications/validations and approving laboratory investigations and deviations.
• Knowledge of USP, EU and JP cGMP guidelines.
• Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, and governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to present information and respond to questions from managers, clients, customers, and the public.
• Ability to solve practical problems in situations with limited standardization.
• Interpret instructions in written, oral, diagram, or schedule form.
• Basic math and basic algebra/statistics skills.
• Ability to sit for long periods of time and lift up to 20 pounds.
• Proficiency with word processing, database, spreadsheet, PowerPoint, internet, e‑mail, calendar, and telephone.

EEO Statement

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status, are strongly encouraged to apply.