Senior QA Data Compliance Specialist (GMP)

NCBiotech; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior QA Compliance Reviewer to oversee the review and approval of release, in-process, and stability data in a CGMP environment.

You will also validate method qualifications/validations and assess laboratory investigations and deviations for the biopharmaceutical development department. Ideal candidates have extensive CGMP QA experience, strong regulatory knowledge of USP/EU/JP guidelines, and excellent written and verbal communication skills to interface with

Qualifications

• BS and 11+ years experience in CGMP environment within biopharmaceuticals or equivalent.
• Experience in QA review of analytical data (release, in-process, and stability) and review/approval of method qualifications/validations.
• Ability to read, analyze, and interpret technical procedures and governmental regulations.
• Strong written and verbal communication and ability to present information to groups of managers, clients, and customers.
• Ability to sit for long periods and lift up to 20 pounds.

Responsibilities

• Performs compliance review on release, in-process, and stability data.
• Responsible for the review and approval of method qualifications and validations.
• Responsible for the review and approval of deviations and laboratory investigations.

Skills

CGMP experience

QA review of analytical data

Regulatory knowledge (USP/EU/JP cgmp)

Analytical data interpretation

Written and verbal communication

Education

Bachelor's degree in a related field

Master's degree in a related field

Job description

KBI Biopharma, Inc. is seeking a Senior QA Compliance Reviewer to oversee the review and approval of release, in-process, and stability data in a CGMP environment.

You will also validate method qualifications/validations and assess laboratory investigations and deviations for the biopharmaceutical development department. Ideal candidates have extensive CGMP QA experience, strong regulatory knowledge of USP/EU/JP guidelines, and excellent written and verbal communication skills to interface with