Job description
Position Summary:
This individual provides on-the-floor compliance support and inspections as a Quality Assurance representative during commercial manufacturing operations. Review of executed electronic batch records and electronic logbooks, conduct QA walkthroughs, room clearance release activities (including changeover), participate in safety walkthroughs. Assist Manufacturing Operations staff with assessment, initiation, notification, and closure of deviations from established procedures. (Night Shift)
Position Responsibilities:
- Performs on-the-floor inspections as a QA representative. Provides compliance support to manufacturing operators during commercial manufacturing operations. Works with the manufacturing staff to resolve compliance issues. Participated in safety walkthroughs of the cGMP manufacturing facility.
- Performs QA review of executed electronic batch records and logbooks.
- Works directly with Manufacturing Operations staff to resolve deviations and other compliance issues in a timely manner.
- Supports room clearance release activities (including changeover activities) at campaign start-up, after shutdown / maintenance, and to include QA oversight of GMP readiness activities in Manufacturing
- Support Document Control for issuance of batch records and logbooks as needed during off hours
- Participates in process improvements.
- Attend relevant meetings in support of Manufacturing operations.
Please Note: This is for Nights - 12 hour Rotating Shift
Position Requirements
- BS with 1 year of related experience, AS with 2 years related experience, HS degree with 4 years related experience.
- Technical knowledge of upstream and/or downstream processing techniques and equipment. Experience working at a cGMP manufacturing environment is required, with strong understanding of FDA, EU, and ROW cGMP regulations.
Salary Range: $50,000 - $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.
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