Night-Shift GMP Operations Coordinator

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

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401(k) with company contribution

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL is seeking an Operations Coordinator to maintain manufacturing documentation, monitor process changes, and support production data analysis. The role involves batch record review, SOP updates, and coordinating with multiple departments to ensure compliance with GMP and QA standards.

Candidates should have a high school diploma (associate preferred) and at least 1 year in a regulated environment.

Qualifications

• High School diploma or equivalent required.
• Associate degree preferred.
• Minimum 1 year of relevant experience in a regulated industry.
• Proficient with Microsoft Office.
• Working knowledge of SAP preferred.

Responsibilities

• The Operations Coordinator is responsible for maintaining documentation of the manufacturing procedures and processes for manufacturing.
• 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.
• 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

Attention to detail

Communication skills

Independent worker

English proficiency

Education

High School diploma or equivalent

Associate degree preferred

Tools

SAP

Microsoft Excel

Job description

Fresenius Kabi in Melrose Park, IL is seeking an Operations Coordinator to maintain manufacturing documentation, monitor process changes, and support production data analysis. The role involves batch record review, SOP updates, and coordinating with multiple departments to ensure compliance with GMP and QA standards.

Candidates should have a high school diploma (associate preferred) and at least 1 year in a regulated environment.