cGMP Production Documentation & Lot Control Coordinator

Step into a day in this role

You arrive between 6:00 and 8:00 am, open your dashboard, and line up the day’s batches against packaging schedules. You confirm that every instruction packet and label set reflects the latest revision, then walk the floor to observe Standard Work in action and head off issues before they become release delays. Back at your desk, you reconcile inventory transactions, calculate yields, and resolve any discrepancies with Processing, Packaging, and Shipping. By afternoon, you are collaborating with Quality Systems to advance batch records through review, finalizing ADC schedules with supervisors, and ensuring outbound chemical tank truck documentation meets DOT requirements. Before you leave, you stage labels for tomorrow’s runs and make sure the department is stocked with essential office supplies.

Schedule and pay

• Daytime hours, Monday through Friday (approximate 6 am to 8 am start)
• $42,000 – $46,000 salaried non-exempt (eligible for overtime), paid biweekly

Your core responsibilities

• Own lot control for intermediate batches, aligning lot assignments with packaging plans.
• Prepare Manufacturing Instructions for Processing and create the documentation, instructions, and inventory aids required by Packaging.
• Ensure all issued documents are accurate and at the current revision level.
• Track schedule changes to proactively adjust label and documentation needs.
• Review batch records for completeness and cGMP compliance; compute product and label yields and investigate variances outside expected ranges.
• Guide plant personnel and Manufacturing supervisors to correct batch record errors identified internally or by Quality Systems, including recording mistakes, label and product sampling issues, equipment variances, and quantity discrepancies for raw materials, labels, and finished goods.
• Conduct in-process shop floor walks to audit Standard Work and reduce risk of errors and release delays.
• Manage the flow of batch records through review and verify cGMP requirements for Quality Systems acceptance for release.
• Accept direct accountability for release delays tied to documentation or inventory inaccuracies.
• Mentor and train union employees and Manufacturing supervisors on system topics, including finalizing ADC schedules.
• Audit inventory transactions from Processing, Packaging, and Shipping; reconcile variances with physical counts when needed.
• Manage DOT documentation for outbound shipments of chemical tank trucks.
• Provide backup in the label room: receive labels, stage for runs, and manage non-inventory label items.
• Maintain office supply inventory for the Manufacturing department.

Qualifications

Required

• High school diploma or GED plus 2 years of related experience, or an associate degree
• Proficiency in Microsoft Word and Excel (approximately 3–5 years)

Preferred

• 2+ years in manufacturing inventory or a related field
• 1+ year working with FDA, cGMP, or ISO manufacturing regulations
• Oracle experience
• Background in Lean Manufacturing and Continuous Improvement
• Experience in chemical manufacturing
• Exceptional attention to detail
• Strong team communication skills (oral and written)
• Self-directed, with strong analytical and organizational abilities
• Positive leadership, including the ability to train others and guide coordination activities

Work environment and physical expectations

• Lifting: 10–25 lbs
• Walking: 15% of the time
• Standing: 5% of the time
• Sitting: 80% of the time
• Typing and data entry: 40% of the time

Tools and systems

• ERP and MRP systems
• Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Experience in a manufacturing environment
• Microsoft Excel and Microsoft Office
• Oracle
• Reading and interpreting batch records
• ERP software (Oracle) and Microsoft Office

What STERIS offers

We value our employees and provide a comprehensive benefits package to support your health, well-being, and financial future.

• Market competitive pay
• Extensive paid time off and 9 added holidays
• Excellent healthcare, dental, and vision coverage
• Long and short term disability coverage
• 401(k) with company match
• Maternity and paternal leave
• Additional add-on benefits and discounts, including pet insurance
• Tuition reimbursement and continued education programs
• Excellent opportunities for advancement and a stable, long-term career