Lead Floor Clerk

Our 503B FDA-registered outsourcing facility located in Irving, TX is looking for a motivated individual to join our production department. This person’s primary responsibility will be monitoring the production floor, ensuring productivity and daily quotas are met, verifying the work of the technicians for accuracy, ensuring Good Documentation Practices, handling documents, and supporting the operators with their daily tasks. Hours of operation M-F, 9 am – 6 pm with occasional overtime.

JOB DESCRIPTION

· Monitoring and reporting the effectiveness of production floor activities and employees’ performance.

· Inventory and storage area organization and maintenance.

· Ensure shipments’ and inventory transactions’ accuracy to and from third party lab. Maintain records of these transactions.

· Communicate job expectations, guide employees, and monitor performance.

· Determine staffing levels and workload distribution.

· Maintain records, document necessary information, and utilize reports to project production needs.

· Identify areas of improvement and suggest improvement for management’s consideration.

· Coordinate activities with other departments.

· Monitor employees are arriving and leaving in a timely manner according to schedule.

· Occasionally assist with writing deviations and investigations.

· Manage daily flow paperwork involving production and ensure GMP documentation.

· Maintain and ensure compliance with policies and procedures.

· Provide assistance to the operators in their assigned responsibilities.

· Maintain a clean, safe, and organized work area.

· Handle batch records and controlled documents to ensure accuracy.

· Ensure safe handling of manufactured products.

· Reconcile batch records and other related documents for accuracy.

ESSENTIAL FUNCTIONS:

· Ensure proper production floor behavior is followed by employees.

· Submit and receive products from third party labs and maintain records.

· Verify tasks performed by production floor technicians.

· Communicate verbally with various personnel on the workstation team or in support of the workstation team.

· Ensure the production floor is orderly and clean.

· Monitor, count, and update inventory.

· Track productivity of the production floor employees.

· Ensure shelves are properly stocked with supplies and products.

PERFORMANCE CRITERIA:

· Always maintain a professional and helpful approach when interacting with coworkers, managers, and departmental personnel.

· Maintain a clean and organized work area at all times.

· Always maintain a strong dedication to quality and ensure compliance to SOP.

· Always be adaptable when it comes to job tasks and be adaptable to changing needs.

· Provide processing documentation that is accurate, legible, and complete.

· Ensure that all work is carried out in accordance with CGMP guidelines.

· Deliver reliable work with 100% accuracy.

QUALIFICATIONS/EDUCATION:

· A high school diploma or GED; or similar experience and/or training; or an equivalent combination of education and experience.

· Ability to perform routine math calculations.

· Strong leadership qualities.

· Excellent communication abilities, both verbally and in writing.

· Ability to read and interpret instructions and ensure it is being followed.

· Good understanding with manufacturing processes.

· The ability to manage multiple tasks and prioritize accordingly.

· Experience with word processing and spreadsheet programs.

· The ability to work without direct supervision.

· Ability to collaborate effectively with others.

· Strong attention to detail.

Responds to management questions, comments, and concerns in a timely manner and ensures that any special circumstances are communicated and addressed in a proactive and positive manner.

Scope: Respects and maintains the confidentiality of information. Adheres to all policies, procedures, compliance, and HIPAA guidelines. Works with minimal direction consults with leadership as needed.