Batch Record Review Coordinator

Kansas City, MO 64137

Posted: 01/13/2025 Employment Type: Contract Division: Life Sciences Job Number: JN -012025-20110 State: Missouri

Job Description

Batch Record Review Coordinator

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire, and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

  • Title: Batch Record Review Coordinator
  • Location: Kansas City, MO
  • Industry: Pharmaceutical
  • Hours: Monday - Friday Day Shift: 8am - 4:00pm
  • Salary: $20.00 (Paid Weekly - Benefits Available)
  • Employment Type: Contract with potential to go permanent

Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply, and optimal performance of our products.

Position Overview:
The Kansas City Batch Record Review Coordinator serves as a liaison between Project Management and Packaging Operations. Responsible for assisting in the coordination of activities related to creating packaging batch records and other GMP documents & materials that comply with the clients scope. Ensures that the work that is carried out by Packaging Operations is in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs).
The primary responsibilities of this position include creating batch records based on source documentation while identifying customer needs and the ability to prepare batch records following GMP standards. The individual will be client interacting to facilitate customer questions. This position will coordinate receiving of materials as associated with PO generation and zero-dollar Purchase Orders. Furthermore, this position may participate in the internal or client audit program and may assist with investigations related to packaging.


Essential Functions:

  • Assist Project Managers with development of clinical, stability, and commercial packaging protocols and materials.
  • Create batch records based on project source documentation from Project Management including primary, secondary labeling, kitting and assembly.
  • Interact with Production, Quality Assurance, Label Control, and Package Engineering personnel to communicate project requirements and gather appropriate paperwork for batch records.
  • Item Master identification and creator of request forms, JD Edwards Router, BOM, Purchase Order, and Work Order creation, GSA set up.
  • Create Change Orders and drive resolution to changes required during production.
  • Client interaction and communication to facilitate responses to customer questions and provide batch records etc., as required.
  • Support project timelines as directed by Management, ensuring that key project millstones are met and projects progress in a satisfactory and timely manner.
  • Deliver the packaging documentation within agreed upon timelines, ensuring Right First Time
  • Work with Label Designers to obtain item numbers for labels and randomization copies for batch records.
  • Coordinate receiving and distribution activities, related to item master requests, zero-dollar Purchase Order generation, Shipment request completion, as required.

Education and Experience:

  • A high school diploma or GED is required
  • Associates or bachelor s degree is preferred
  • Two years of experience in packaging and/or technical writing preferred
  • Attention to details, reviewing batch records
Knowledge/Skills Requirements:
  • GMP and SOP working environment is a must
  • At least one year experience working in a pharmaceutical or related GMP/FDA regulated environment
  • Experience working in preparation of packaging batch records, packaging, labeling, assembly, and distribution of clinical trial materials is preferred
  • Must possess verbal, written, and interpersonal communication skills appropriate for a business environment
  • Must have ability to work with minimal supervision
  • Must be computer literate with past experience using spreadsheets and word processing programs
  • Office environment and some work on the production floor and in warehouse environment

EOE/ADA

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About Kansas City, MO

Ready to take the next step in your career? Explore exciting job opportunities in the vibrant city of Kansas City, Missouri, where endless growth possibilities await! Known for its thriving arts scene, including the Nelson-Atkins Museum of Art and the Kauffman Center for the Performing Arts, along with its iconic BBQ cuisine, such as Gates BBQ and Joe's Kansas City, this area offers a unique blend of culture and charm. Cheer on the Kansas City Chiefs or Kansas City Royals at Arrowhead Stadium or Kauffman Stadium, or enjoy outdoor activities at the beautiful Loose Park or along the scenic Missouri River. Discover why Kansas City, MO is the perfect place to advance your career and experience a rich and dynamic lifestyle.