Production Specialist

Cambrex•Charles City, IA

7d•Onsite

About The Position

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.

Requirements

Strong computer skills with proficiency in Microsoft Office, particularly Excel, Word, and Outlook.
Ability to accurately enter, retrieve, and maintain information in SAP or similar enterprise systems.
Ability to work with spreadsheets, databases, and electronic records.
Strong data entry skills with a high degree of accuracy.
Ability to review detailed technical and production documentation for completeness, accuracy, and consistency.
Ability to perform basic calculations, data reconciliation, and yield calculations.
Ability to learn and accurately apply departmental procedures and regulatory requirements.
Strong organizational and document management skills.
High school diploma or GED required.
Ability to wear required PPE (steel-toe shoes, safety glasses, fire-retardant clothing).
Physical ability to occasionally lift up to 25
Regularly sit, stand, bend, reach, and move throughout the
Comfortable working in a production/lab environment with potential exposure to: Dust, odors, noise, fumes, and varying temperatures.

Nice To Haves

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.
Associate degree in Business Administration, Operations, Manufacturing, Supply Chain, Information Systems, or a related field preferred.

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.