Document Coordinator

7 days ago

Maryland Heights, United States Kindeva Drug Delivery Full time

Kindeva Drug Delivery

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

ROLE SUMMARY

The successful candidate will possess strong computer background skills including advanced Microsoft Word skill as well as attention to detail and good communication skills. This position works with colleagues of all levels on the site and with off-site customers as well.

The document control coordinator is responsible for coordinating the system by which changes are made to controlled GMP documents such as SOPs, Forms, Batch Records, printed material, specifications, device design documents (DHF documents) etc. This includes maintaining the Numbering and Sequential Numbering databases and Tracking databases; includes formatting various document types to conform to approved templates within the Document Management System (DMS); finalizing approved GMP documents and ensuring copies are distributed to contract customers and Regulatory Affairs as needed. Responsible for preparation and maintenance of master GMP documents.

ROLE RESPONSIBILITIES

The essential functions of the position include, but are not limited to:

  • Creates and audits new documents and changes to existing GMP documents such as: Standard Operating Procedures (SOPs), Master Batch Records, Design History File Documents, Material Specifications, On-The-Job training, Reference Manuals, Job Aids and Forms for quality manufacturing and testing of product and market availability.
  • Formats GMP documents within the DMS.
  • Coordinates and maintains GMP documents within the DMS.
  • Assures completeness of SOP summary of changes, properties, and format for GMP documents such as SOPs, Master Batch Records, Design History File Documents, Material Specifications, On-The-Job training, Reference Manuals, Job Aids and Forms.
  • Maintains and publishes master listing of the following: Procedures, Batch Records, Material Specifications, and Controlled Forms.
  • Maintains accurate and complete documents.
  • Performs other duties relating to QA Documentation or special projects as assigned by management.
  • Creates and maintains database tracking systems throughout the QA Documentation department.
  • Controlled document and logbook creation, issuance, reconciliation, and document archival.
  • Serve as document author and SME for document management processes.
  • Ensure Master Batch Records, Specifications, Laboratory Methods, Protocols, and similar cGMP documentation receive client/ third-party approval prior to implementation.
  • Occasional late night or weekend work may be required depending on business need.
  • Other duties as assigned.
BASIC QUALIFICATIONS

Associates degree in a science field and some experience in a GMP environment, preferably experience in the Quality department.

PREFERRED QUALIFICATIONS
  • Effective verbal and written communication skills
  • Strong Time Management and Organization skills
  • Detail-Oriented
  • Ability to follow procedures and processes
  • Responsiveness
  • Proficient with computer-based productivity tools such as MS Word and MS Excel
  • Advance Microsoft word skills
#LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying.

Covid-19:

Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.

Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.

Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Other details
  • Job Family Apprentice II
  • Job Function Technical Professional
  • Pay Type Hourly


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