QA Specialist II

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

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. This position is also responsible for the review and
approval of method qualifications and validations. Another responsibility is the
review and approval of laboratory investigations and deviations associated with the
biopharmaceutical development department.

JOB RESPONSIBILITIES:

• Performs compliance review on the following records: 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.

MINIMUM REQUIREMENTS:

• BS and 11+ years experience or MS and 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 the review and approval of laboratory investigations and
  deviations. Knowledge of USP, EU and JP cGMP guidelines.
• Ability to read, analyze, and interpret general business periodicals, professional journals,
  technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to solve practical problems and deal with a variety of concrete variables in
  situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Basic math skills are required.
• Ability to apply concepts of basic algebra and statistics.
• Be able to sit for long periods of time.
• Ability to lift 20 pounds.
• Ability to use word processing, database, spreadsheets, power point, internet, e-mail, calendar, computer, telephone

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.