Document Control Coordinator I/II
Job Description
Position Summary:
- Performs review of cGMP documents in EtQ in preparation for Department/Technical, QA, and client (if applicable) review and approval.
- Communicates with the client regarding document review and approval and updates to the cloud, if applicable.
- Represents Document Control on project-related teams and assists with Production deliverables.
- Supports internal audits, client audits and regulatory inspections.
- Controls issuance, receipt, and archival of cGMP documentation.
- Maintains controlled forms (logbooks, etc.) for applicable departments.
- Fulfills documentation requests from internal and external customers.
- Supports client audits and regulatory inspections.
Position Responsibilities:
- Manages the EDMS system, as well as paper-based controlled documents.
- Issues manufacturing records for each project campaign.
- Images controlled documents for electronic archival in an organized fashion to allow for ease of reference; reconcile, as needed, and archive all hard copy controlled documents submitted to Document Control in an organized fashion to allow for ease of retrieval; prepare documents for off-site storage.
- Transmits controlled documents to clients for approval and for reference.
- Creates and issues logbooks and other controlled forms as required.
- Manages documentation requests from internal customers in a timely manner.
- Assists with regulatory and client audits by providing requested documents to auditors and answering questions related to document control.
- Able to react to change productively and handle other essential tasks as assigned.
Position Requirements:
- BA/BS in Business Administration or related field, or an equivalent combination of education and experience.
- Levels are assigned according to experience.
Salary Range: $19.23 - $29.80
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 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.
Date Posted
08/23/2024
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