Sr QA Specialist Job at KBI Biopharma
Position Summary:
Responsible for performing compliance review of Biopharmaceutical Development GMP data. Review and approval of release, in-process, and stability test data worksheets. Responsible for release of incoming materials to support GMP manufacturing
Position Responsibilities:
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Performs compliance review on the following records: release and stability data.
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Responsible for release of materials for GMP manufacturing. Works directly with Warehouse personnel to release materials and resolve any compliance issues.
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Reviews and approves data worksheets to support on-going manufacturing operations.
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Works directly with Biopharmaceutical Development and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner.
Position Requirements:
BS in a scientific discipline with 9+ years’ experience or MS and 7+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
Salary Range: $80K - $100K
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.
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