Production Specialist

Cambrex - Charles City; Charles City (IA); On-site; USD 45,000 - 65,000; Full time

Job summary

Cambrex - Charles City is seeking a Production Operations Coordinator to support the Production department with administrative tasks, data entry in SAP, and batch record coordination. The role requires meticulous records management, QA collaboration, and census of inventory and documentation in a regulated environment.

The candidate will assist with pre-campaign readiness, report generation, and document control while maintaining accurate batch records and supporting continuous improvement

Qualifications

• 2+ years of administrative, data entry, production support, manufacturing, quality, or related experience preferred.
• Experience with electronic databases, ERP systems, or document management systems preferred.
• Experience in regulated manufacturing environments (pharma/chemical/food) preferred.
• Experience with SAP or similar ERP system preferred.
• Experience with production records, batch records, inventory records, or other controlled documentation preferred.
• Experience with spreadsheets and data tracking preferred.
• High school diploma or GED required.
• Associate degree in related field preferred.

Responsibilities

• Track operator discrepancies and update tracking spreadsheets.
• Perform Data Entry in SAP while reviewing batch records.
• Issue batch records from QA to production supervisor group.
• Deliver completed batch records to QA Auditor group.
• General administrative duties to support department needs.
• Compile data and track metrics to support improvements.
• Revise and maintain documents such as SOPs, batch records, shipping docs.
• Process and maintain monthly, quarterly and annual department reports.
• Data entry of batch/cleaning records into SAP.
• Support annual physical inventory.
• Data entry of controlled substance container records into the DEA database; quarterly audit.
• Maintain department files (shift bids, vacation schedules).
• Review operations batch records/cleanout before QA approval.
• Disposals of samples from SAP.
• Inventory removal from WWTP on SAP.
• Scanning batch records before QA review.
• Assist with pre-campaign start up/batch readiness tasks.
• Enter and maintain machine time entries (CORR) for designated areas.

Skills

Administrative support

Data entry

Education

Associate degree in Business Administration / Operations / Manufacturing / Supply Chain / Information Systems

Tools

SAP

Document management systems

Job description

Overview

The Production Operations Coordinator provides administrative, documentation, data management, and operational support to the Production department. This role is responsible for maintaining accurate production records and data in SAP, coordinating the movement and review of batch records between Production and Quality Assurance, tracking operational discrepancies and metrics, and supporting inventory and documentation processes.

The position plays an important role in ensuring production records are accurate, complete, and available for timely QA review and approval. The role also supports department reporting, document control, inventory activities, controlled substance recordkeeping, and pre-campaign readiness activities. Success in this position requires a high level of attention to detail, organization, accuracy, follow-through, and the ability to work effectively with Production, QA, and other site functions in a regulated manufacturing environment.

Responsibilities

• Track operator discrepancies and update the tracking spreadsheets for supervisor group.
• Perform the Data Entry functions in SAP while completing production review of batch records.
• Issuing batch records from QA to the appropriate production supervisor group.
• Delivering completed and reviewed batch records to the QA Auditor group.
• General administrative duties to support department needs
• Compile data and track metrics to support improvement efforts
• Help revise, issue and maintain documents such as Standard Operating Procedures, batch records, department spreadsheets, shipping documents, etc.
• Process and maintain any monthly, quarterly and annual department reports
• Responsible for all data entry of batch record/cleaning record information into SAP.
• Key role in site's annual physical inventory.
• Responsible for data entry of controlled substance container records into the DEA database, maintenance of database and audit for accuracy on a quarterly basis; complete yield worksheets.
• Maintains/updates appropriate department files, including but not limited to: shift bids, and vacation schedules on an annual basis for the upcoming year budget.
• Responsible for review of operations batch records/cleanout records prior to QA approval to assure accuracy
• Disposals of samples from the SAP system.
• Inventory removal from WWTP on the SAP system.
• Scanning of batch records before QA review.
• Assist with pre campaign start up/batch readiness tasks as directed.
• Enter and maintain machine time entries (CORR) for designated areas.

Qualifications

• 2+ years of administrative, data entry, production support, manufacturing, quality, or related experience preferred.
• Experience working with electronic databases, ERP systems, or document management systems preferred.
• Experience working in a manufacturing, pharmaceutical, chemical, food, or other regulated environment preferred.
• Experience working with SAP or a similar ERP system preferred.
• Experience working with production records, batch records, inventory records, or other controlled documentation preferred.
• Experience working with spreadsheets and data tracking preferred.
• High school diploma or GED required.
• Associate degree in Business Administration, Operations, Manufacturing, Supply Chain, Information Systems, or a related field preferred.

Equal employment opportunity, including veterans and individuals with disabilities.

PI287412422