QA Specialist - Deviations & CAPAs
Company: KBI Biopharma Inc.
Location: Durham
Posted on: May 26, 2023
|
|
Job Description:
Position Summary
The QA Specialists on the Deviations and CAPAs team will provide
oversight for the startup and ongoing manufacturing operations at
our new biopharmaceutical manufacturing facility. The individual
will report to the QA Manager of Deviations and CAPAs.
The individual will be responsible for collaborating with
Operations staff on timely resolution of departures from
established standards. The ideal candidate will have experience
providing quality oversight or supporting compliance activities for
a commercial GMP facility. Additionally, experience with single use
equipment and an understanding of upstream, downstream and/or
manufacturing support biotechnology principles is desired.
Willingness to learn by interacting with peers, Operations staff,
and individually through document review is required. Must
thoroughly grasp and be able to clearly present technical concepts.
The Specialist should possess technical writing and problem-solving
skills and a drive for continuous improvement.
This role will be responsible for collaborating with Operations
teams on completion of thorough and robust manufacturing
investigations, implementation of effective corrective/preventative
actions, and manufacturing change controls. The individual is
responsible for working cross-functionally with the Manufacturing,
Engineering, Supply Chain, IT, QC and other key departments to
ensure manufacturing operations are compliant with GxP
requirements. This requires a drive for continuous improvement,
simplicity and superior equipment and human performance.
Position Responsibilities
Position Requirements
Salary Range $67,000 - $85,000
Salary range provided per current averages and expectations. The
salary and job title for this opening will be based on the selected
candidate's qualifications and experience and may be outside this
range. KBI has a robust total rewards strategy which includes an
annual bonus structure for all employees, medical, dental, and
vision coverage, paid PTO and holidays, Sabbatical program, 401K
matching with 100% vesting in 60 days and employee recognition
programs.
KBI Biopharma, Inc. (KBI) is committed to providing a safe and
healthy workplace. Any employee entering a KBI site located in the
US must either (1) have provided proof of full vaccination (as
defined by the CDC) with a COVID-19 vaccination which has been
granted FDA approval or Emergency Use Authorization; or (2) perform
weekly COVID-19 testing with negative test results.
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.
Keywords: KBI Biopharma Inc., Durham , QA Specialist - Deviations & CAPAs, Other , Durham, North Carolina
Click
here to apply!
|