Sterile Room Supervisor (Shift 1...

Xtalks; West Columbia (SC); On-site; USD 60,000 - 85,000; Full time

Job summary

Xtalks seeks a dedicated Cleaning Operations Coordinator to oversee and coordinate all aspects of cleaning in a manufacturing environment. You will conduct walkthroughs, plan cleaning activities, and ensure timely execution in line with cGMP standards, while maintaining precise documentation and coordinating with procurement for supplies.

The role requires strong communication with cross-functional teams, the ability to manage scheduling, overtime approvals, and ensure room readiness.

Qualifications

• Experience with cGMP and document control processes.
• Office software (Word/Excel/PowerPoint) and SharePoint experience.
• Ability to lead investigations, change controls, and procedural updates.

Responsibilities

• Perform quality checks on documents for accuracy and adherence to standards.
• Coordinate and plan cleaning activities aligning with manufacturing priorities.
• Ensure proper clock-in/out, time punches, and timely timecard approvals.
• Monitor time entries and payroll accuracy.
• Communicate with cross-functional teams to align cleaning schedules with production needs.

Skills

cGMP knowledge

Document control

Time management

Interpersonal skills

Communication skills

FDA regulations familiarity

Education

Bachelor of Science preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

SharePoint

Adobe Acrobat

Job description

Job Purpose

This role is responsible for overseeing and coordinating all aspects of cleaning operations to support manufacturing priorities. It involves conducting walkthroughs, planning and scheduling cleaning activities, and ensuring timely execution in compliance with cGMP standards. The position requires strong communication with cross-functional teams to align cleaning efforts with production needs. Additional responsibilities include maintaining documentation, supporting investigations and continuous improvement initiatives, and managing personnel activities such as scheduling, assessments, and overtime approvals. The role also involves inventory oversight, including restocking supplies and working with procurement. Flexibility to assist with hands-on cleaning tasks and room status changes is essential. Overall, the position ensures a clean, compliant, and efficient environment that supports production goals.

• Perform quality checks on incoming documents to ensure accuracy, completeness, and adherence to established standards and guidelines.
• Coordinate and plan cleaning activities by conducting walkthroughs, meeting supervisors, checking cleaning logs, and determining room readiness and material transfers.
• Ensure all team members accurately clock in and out for each shift, break, and lunch period.
• Monitor daily time punches to identify and correct missed or inaccurate entries.
• Review and approve employee timecards by designated deadlines.
• Communicate with cross-functional teams (supervisors, coordinators, production, and other departments) to align cleaning schedules with manufacturing priorities.
• Ensure timely execution of cleaning tasks to support production, including updating priority boards and initiating cleaning processes on time.
• Maintain documentation and compliance by assisting with filing, archiving, and ensuring all cleaning activities are recorded in accordance with cGMP.
• Oversee inventory and supply needs, including restocking, working with procurement, and assisting with room declassification and reclassification when needed.

Job Purpose

This role is responsible for overseeing and coordinating all aspects of cleaning operations to support manufacturing priorities. It involves conducting walkthroughs, planning and scheduling cleaning activities, and ensuring timely execution in compliance with cGMP standards. The position requires strong communication with cross-functional teams to align cleaning efforts with production needs. Additional responsibilities include maintaining documentation, supporting investigations and continuous improvement initiatives, and managing personnel activities such as scheduling, assessments, and overtime approvals. The role also involves inventory oversight, including restocking supplies and working with procurement. Flexibility to assist with hands-on cleaning tasks and room status changes is essential. Overall, the position ensures a clean, compliant, and efficient environment that supports production goals.

Essential Duties And Responsibilities

• Perform quality checks on incoming documents to ensure accuracy, completeness, and adherence to established standards and guidelines.
• Coordinate and plan cleaning activities by conducting walkthroughs, meeting supervisors, checking cleaning logs, and determining room readiness and material transfers.
• Ensure all team members accurately clock in and out for each shift, break, and lunch period.
• Monitor daily time punches to identify and correct missed or inaccurate entries.
• Review and approve employee timecards by designated deadlines.
• Communicate with cross-functional teams (supervisors, coordinators, production, and other departments) to align cleaning schedules with manufacturing priorities.
• Ensure timely execution of cleaning tasks to support production, including updating priority boards and initiating cleaning processes on time.
• Maintain documentation and compliance by assisting with filing, archiving, and ensuring all cleaning activities are recorded in accordance with cGMP.
• Oversee inventory and supply needs, including restocking, working with procurement, and assisting with room declassification and reclassification when needed.

Job Specifications And Qualifications

• Ability to lead or assist with investigations, change controls, and procedural updates
• Flexibility to assist with manual cleaning activities when needed
• Ability to make decisions under pressure and manage multiple tasks efficiently

Knowledge & Skills

• Technical background preferred, with knowledge of cGMP, and FDA regulations.
• 1-3 years of experience with Microsoft Word, Excel, and PowerPoint preferred.
• Strong understanding of document control procedures, standards, and best practices
• Competent in Microsoft Word and Excel
• Knowledgeable in Adobe Acrobat (PDF) advanced features and workflows
• Familiar with document management software, including SharePoint
• Effective time management skills including prioritizing and scheduling.
• Effective communication and interpersonal abilities to work with cross-functional, fast-paced teams.
• Ability to prioritize tasks, manage time efficiently, and meet deadlines.
• Familiar with relevant industry regulations and compliance standards.
• Discretion in handling sensitive and confidential information.
• Strong critical thinking, analytical, problem-solving, and interpersonal skills
• Strong organizational skills with the ability to manage multiple projects or assignments simultaneously.

Education/Experience

• Bachelor of Science is preferred but not required.

Working Conditions / Physical Requirements

• This position requires bending, typing, lifting (up to 50 1bs.), standing, sitting and walking throughout the facility.