Manufacturing Operations Coordinator (Data & Compliance)

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 31,000 - 34,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holiday and personal**s

Employee assistance program

Health benefits: medical, prescription

Dental and vision coverage

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking an Operations Coordinator in Melrose Park, IL to maintain documentation of manufacturing procedures and processes. You will monitor process changes, revise documents, and communicate updates to production areas, while performing data analysis to support investigations and production decisions.

Responsibilities include batch records review, data entry in SAP/LIMS, inventory coordination, and maintaining SOPs.

Qualifications

• High School diploma or equivalent required; Associate degree preferred.
• Minimum of 1-year relevant experience in a regulated industry preferably pharmaceutical or healthcare.
• Proficient with Microsoft Office products.
• Working knowledge of SAP strongly preferred.
• Must be able to work independently and initiate self-developed projects to assist production operations.
• Strong written and oral communications skills are required.

Responsibilities

• Calculates results and reconciliations on batch records and reviews in accordance with current Good Documentation Practices Policy and SOP all documentation (including but not limited to Batch Records, Cleaning/Sanitization Attachments, section of Protocols related manufacturing processes, etc.) as required by production department.
• Supports all activities needed outside Hygiene Zone as required: documentation (attachments, logbooks, etc.) requests; brings vendors to Hygiene Zone; training related requests; monitors batch records corrections need, and other non-routine requests (e.g., production supply from Central Storage)
• Works within and maintains computer programs to calculate and trend required production data such as but not limited to: DPM reports, down-time reports, yield reports, re-inspection reports, daily production reports, etc.
• Keeps and maintains inventory of all stock items and order when necessary. Orders machine parts, tools, and safety items at times.
• Completes and tracks Production weekly time sheets, logbooks reviews, unless directed otherwise by Department Manager.
• Performs daily data entry activities in LIMS, SAP, or other platforms to support manufacturing process as indicated by Department Manager. At times, identifies materials with SAP tags and coordinates movement of these materials with other departments, as indicated by Department Manager.
• Knowledge of good manufacturing practices and principles.
• Maintain all departmental filing and keeps production forms current. May perform this task for other Production departments at times, as indicated by Compounding Manager. 9)Updates Compounding Standard Operation Procedures and evaluates and revises standard operating procedures as needed for method changes and/or corrective action.
• Conducts research required to support investigation of non-compliance issues or aids in determining root cause of non-compliance, developing corrective action, and/or assessing impact on product to complete investigation for management approval.
• Develops and executes special projects (e.g. down-time tracking, etc.) as assigned.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related

Skills

Communication skills

Independent worker

Attention to detail

Education

High School diploma or equivalent

Associate degree preferred

Tools

SAP

Microsoft Office

Job description

Fresenius Kabi USA, LLC is seeking an Operations Coordinator in Melrose Park, IL to maintain documentation of manufacturing procedures and processes. You will monitor process changes, revise documents, and communicate updates to production areas, while performing data analysis to support investigations and production decisions.

Responsibilities include batch records review, data entry in SAP/LIMS, inventory coordination, and maintaining SOPs.