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

Job Summary Hourly Payrate: $22.50 to $25.00 Overnight Shift Differential $1.75 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Job Responsibilities:

• The Operations Coordinator is responsible for maintaining documentation of the manufacturing procedures and processes for manufacturing. This position strives to monitor changes in processes, revise documentation, and communicate to appropriate production area(s). They are responsible for all data analysis, supporting investigation efforts required to support the needs of the production department(s).
• 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

Job Requirements:

• 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.
• The Company’s primary business language is English.
• The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

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