KBI US Principal QA Specialist

Position Summary:

This individual is responsible for the compliance review of Biopharmaceutical GMP data. This includes the review and approval of in-process release and stability test data. Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification method transfers method validations creation and revision of test methods specifications stability studies laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Collaborates with clients laboratories manufacturing QA batch disposition and other internal stakeholders as needed to achieve site operational and department specific goals. Cultivates and maintains Quality culture.

May perform as a team lead for a specific responsibility listed below in which case the Approximated amount of time will be skewed toward the specific responsibility.

Position Responsibilities:

• Performs timely review of test data for in process release and stability samples. Assures activities comply with required procedures cGLP and cGMP requirements.

• Responsible for the review and approval of method verification transfer qualification and validation related to the testing of in-process release and stability testing.

• Provides QA support for Deviations CAPAs Laboratory Investigations Change Controls and Projects related to laboratory processes instruments specifications methods and SOPs.

• Attends relevant operational meetings in support of Manufacturing operation analysis and disposition activities. Supports client audits and regulatory inspections as required. Other activities as assigned by Management.

• Provides QA oversight of special projects such as implementation of new processes to support site operational and department goals.

• Serves as trainer/mentor for QA Specialists and cross-trainer for employees in other departments to support individual development goals.

Minimum Requirements:

Bachelors degree and 10 years experience or Masters degree and 6 years experience in a QA QC or cGMP environment in Biopharmaceuticals or equivalent. Demonstrated strong interpersonal skills ability to work in a team environment attention to details and excellent problem resolutions skills. Strong understanding of FDA EU and cGMP regulations is required. Experience in Quality Control and Quality Systems is beneficial.

Salary: $113000-$156000

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.