Operations Production Coordinator (PM Shift)

About the role

The Operations Coordinator is responsible for managing material and document management in the building. Key responsibilities include understanding production scheduling and workflow, material control, quality, cGMP, GDP, and safety. The role also involves utilizing computer systems to manage materials for production, interfacing with manufacturing monitoring systems to track and trend data, coordinating deliveries, ensuring inventory accuracy, reviewing and auditing data, and communicating operational events.

Responsibilities

• Understands production scheduling and workflow, material control, quality, cGMP, GDP, and safety as part of job duties.
• Utilizes computer to manage weekly schedule, perform transactions in inventory system (SAP) to manage materials for production.
• Interfaces with company’s electronic system to generate, release, and close out batch records and/or any other documents.
• Interface with manufacturing monitoring system to track and trend data.
• Carefully coordinates the delivery of raw materials and/or commodities needed to meet production schedule.
• Ensures inventory accuracy and maintains 5S in building warehouse and stockroom.
• Reviews and audits the data and records generated by manufacturing operations in the processing of a material or product batch.
• Ensures any batch record errors are corrected, all batch record components are present, and exception documents are referenced and approved.
• Ensures documents in building are retained, filed securely, and in compliance with company policies and applicable regulations.
• Communicates all operational events and issues with appropriate individuals in a clear and timely manner.
• Demonstrates compliance with company policies, safety standards and applicable regulations.
• Interacts and works with other departments and external vendors.
• Develops and implements improvements for improved compliance and/or efficiencies.

Requirements

• High School Diploma or GED required.
• Strong technical knowledge with manufacturing experience in chemical, biological, pharmaceutical, or similar environment.
• Strong knowledge of GDP and GMP regulations.
• Proficient use of basic computer programs (i.e. Microsoft Office, Email, etc).
• Proficient use of manufacturing monitoring system to track and trend data (i.e. PI, D3, DeltaV, etc).
• Must be proficient with SAP.
• Good interpersonal relations and communication skills (verbal and written) required.
• Good analytical skills and attention to detail required.

Qualifications

• High School Diploma or GED required.
• Strong technical knowledge with manufacturing experience in chemical, biological, pharmaceutical, or similar environment.
• Strong knowledge of GDP and GMP regulations.
• Proficient use of basic computer programs (i.e. Microsoft Office, Email, etc).
• Proficient use of manufacturing monitoring system to track and trend data (i.e. PI, D3, DeltaV, etc).
• Must be proficient with SAP.
• Good interpersonal relations and communication skills (verbal and written) required.
• Good analytical skills and attention to detail required.

Skills

• Strong technical knowledge with manufacturing experience in chemical, biological, pharmaceutical, or similar environment.
• Strong knowledge of GDP and GMP regulations.
• Proficient use of basic computer programs (i.e. Microsoft Office, Email, etc).
• Proficient use of manufacturing monitoring system to track and trend data (i.e. PI, D3, DeltaV, etc).
• Must be proficient with SAP.
• Good interpersonal relations and communication skills (verbal and written) required.
• Good analytical skills and attention to detail required.

Benefits

• Paid time off (vacation, holidays, sick).
• Medical/dental/vision insurance.
• 401(k) plan.

Pay

No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Schedule

The shift schedule is night shift, every other Wednesday and Thursday-Saturday.