Work Schedule: Monday-Thursday 4:30pm-3am

JOB QUALIFICATIONS:

• Strong understanding of Good Manufacturing Practices (GMP), FDA regulations, and other relevant quality standards (e.g., ISO 9001)
• Excellent attention to detail and analytical skills, with the ability to identify and resolve discrepancies in batch records
• Experience leading or supervising a team is preferred
• Effective communication skills, with the ability to collaborate across departments and communicate complex information clearly and concisely
• Proficiency in Microsoft Word and Excel preferred
• Proficiency in Oracle EBS
• Fluent in both spoken and written English and Spanish
• Math and weight measurement proficiency

POSITION RESPONSIBILITIES:

• Assign priorities for the shift based on daily needs
• Maintain constant communication with customer service and quality control to make sure orders are being released on time
• Lead a team of batch record reviewers, providing guidance, training, and support to ensure consistent and timely review of records
• Identify discrepancies, errors, or deviations in batch records and collaborate with relevant departments to resolve issues in a timely manner
• Ensure that batch records are maintained in accordance with company policies and regulatory requirements, including proper documentation and archiving
• Perform any WIP transactional corrections required
• Communicate end of shift needs to the Production Manager
• Assist with recording WIP completions after each skid is prepared through Warehouse Management System and print the corresponding LPN labels for each pallet as needed
• Ensure all returned components are properly counted, labeled (LPN) and returned to the warehouse
• Verify the batch folder of each finished job from production lines and supporting departments to confirm that information is properly recorded and the documents are in order according to applicable SOPs
• Verify changeover time and labor hours using Red Zone tableau for the production lines
• Verify units produced for the production lines using Oracle
• Record information from the Shift Production Report for the production lines including hours worked, staff used and units produced in Oracle (if applicable)
• Record information from the Shift Production Report for supporting departments including hours worked and staff used
• Verify raw materials, quantity used, amount made and issuance using Oracle for supporting departments
• Record in Oracle samples, returns and waste for each batch record folder and print reconciliation reports
• Additional tasks as needed

PHYSICAL REQUIREMENTS:

• The ability to sit or stand for extended periods while reviewing batch records, attending meetings, or collaborating with team members
• Proficiency in using hands and fingers to manipulate small objects, handle paperwork, and operate computer keyboards or other equipment
• The ability to move around the manufacturing facility, including walking between production areas, offices, and laboratories as needed
• Occasional lifting of boxes, files, or other materials weighing up to a certain weight limit, typically not exceeding 25-30 pounds, to retrieve or organize documents or supplies
• Regular use of hands and arms for tasks such as typing, writing, and filing paperwork
• Adherence to safety protocols and wearing appropriate personal protective equipment (PPE) when entering production areas or handling hazardous materials
• Occasionally climbing stairs or ladders to access storage areas or equipment platforms
• The ability to bend, stoop, or reach to access files, equipment, or materials stored at various heights or positions