Batch Record Reviewer in St. Louis MO

Full-time @Steris in Entry Level , in Inspector , in Mid-Range , in Quality , in Technology
  • St. Louis, MO, US, 63133 View on Map
  • Apply Before : November 15, 2022

Job Description

Join Steris as Batch Record Reviewer in St. Louis Missouri. At the Steris you will perform tasks as listed below, Apply Steris Manufacturing Operations careers in St. Louis MO.


Position : Batch Record Reviewer

Job Category: Manufacturing Operations

Work location : St. Louis, Missouri

Job Segment : Mid-Range, Inspector, Technology, Entry Level, Quality



At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary
Administrative, entry-level position.  Responsible for knowing, understanding, and supporting the STERIS Safety Philosophy.   Provides accurate and timely documentation and support to all Production Operations departments.  Analyze inventory reports to assure accurate reporting of labor and materials.  Compiles and reviews batch records for completeness. Identifies and corrects inaccuracies prior to forwarding to Quality Systems. Accountable for delays in release and meeting expectations for release times. Mentors plant employees and supervisors on documentation compliance and inventory accuracy.  Proper execution of assigned duties has a direct impact on the efficiencies of the plant and the final customer’s satisfaction.  Contributes to lean transformation by participating on rapid improvement implementation teams.  Other duties assigned by Supervisor to contribute to the support of all Production Operation departments.

 Manages lot control for all intermediate batches and coordinates lot assignments to associated packaging schedules.
Prepares Manufacturing Instructions for the Processing department and essential documentation, instructions and inventory aids for the packaging department.  Accountable for ensuring that all documents issued are accurate and of the current revision.
Utilizes various tools to monitor for scheduling changes that will impact label and documentation needs. Updates appropriate AS400 inventory applications and provides revised documentation to supervision promptly to avoid delays in production. 
Organizes and reviews all batch record documents for completeness and cGMP compliance. Performs product and label reconciliations; investigates and provides explanations when yields fall outside of expected ranges.  Consults with direct supervisor if results of investigations are inconclusive.
Directs plant employees and manufacturing supervisors in the resolution of batch record errors as identified during internal review and review by Quality Systems, including but not limited to document recording errors, label and product sampling, equipment variances and reported quantities of raw materials, labeling components and finished goods.
Conducts shop floor walks to audit and review Standard Work processes with plant employees while in progress to identify specific Continuous Improvement opportunities.
Manages the flow of all batch records throughout the review process until they meet all cGMP requirements and are acceptable for release by Quality Systems.  Directly accountable for delays in product release as they relate to documentation and inventory errors

Mentors/trains union employees on system related issues including but not limited to finalizing ADC schedules
Analyze inventory reports to audit transactions entered by processing, packaging and shipping employees to assure accurate inventory for each intermediate and packaged goods produced.  Reconciles manufacturing related inventory variances with Supervisor.
Maintain office supplies for Manufacturing Supervisors, plant employees and production office including stock tags, copy paper and cGMP log books
Provides back up support to all label room functions including but not limited to, receiving labels, staging labels for packaging runs and managing inventory for all non inventory label items.
Acts as Visual Aid Coordinator responsible for all instructive documents placed on the manufacturing floor. This includes maintaining data base cataloging all documents, conducting periodic audits of document revisions, and authorizing the posting of documents
Responsible for  Toll Production reporting tasks.

Education Degree
Associate’s Degree
Required Experience

2 years experience in manufacturing accounting or related field is desired
1 years experience in FDA/cGMP/ISO manufacturing regulations is desired
Proficiency in Microsoft Word and Excel (3-5 years of experience) is required

Preferred Experience

AS400/Prism experience preferred
Background in Lean Manufacturing/Continuous Improvement


STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Nearest Major Market: St Louis

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Required skills