Assistant Packaging Manager

Direct Digital LLC•West Valley City, UT

9h•$20 - $25•Onsite

About The Position

The Assistant Packaging Manager plays a crucial role in overseeing daily packaging operations, ensuring adherence to quality standards, and meeting production goals. This position involves managing personnel, monitoring equipment performance, and ensuring compliance with regulatory requirements such as FDA cGMPs. The Assistant Packaging Manager will also be responsible for training staff, identifying and resolving operational issues, and collaborating with other departments to achieve production targets. This role requires strong leadership, problem-solving skills, and a thorough understanding of packaging processes and equipment.

Requirements

Understands operating parameters and capable of operating all equipment in Packaging with proficiency and in accordance with current SOPs, and in alignment with manufacturer’s specifications.
Understands, and manages staff to strictly adheres to all FDA cGMP’s as defined by 21 CFR Part 111 and Part 117.
Able to proficiently read, speak and write English to meet FDA requirements for record keeping and packaging purposes.
Proficient in adding, subtracting, multiplying, dividing, and calculating percentages; and determining the simple mathematical formulas needed.
Ability to create accountability and to lead by example.
Strong team building, decision-making and people management skills.

Responsibilities

Read and review Batch Records (Work Orders) prior to job start-up to identify and understand all production, validation, and/or special requirements.
Determine the placement of personnel on the production line, according to quality critical skill sets required at each line station.
Verify Line clearance and complete required Line clearance and Cleaning Logs prior to start-up.
Check all incoming components against the batch record to verify they are correct and document receipts in the batch record.
Ensure start-up and in-process quality inspections, testing, and sampling are performed.
Perform periodic reviews of the batch record throughout the production operation to ensure cGMP compliance and completion and accuracy of the appropriate pages.
Notify Production Manager when tests and/or inspections do not pass.
Verify all coded information (lot number and expiration date) are set correctly throughout the packaging line and complete all qualified challenges on a production line.
Confirm set up of equipment to run product to specification.
Monitor equipment performance during packaging.
Oversee assembly packaging specialists.
Ensure that Work Orders (WOs) are completed on time, requiring collaboration with other departments.
Identify and resolve packaging problems in a timely manner.
Conduct daily huddles, communicating challenges to Packaging Manager, Maintenance, and Quality.
Prepare Work Order(s) (i.e., components) for the next shift and/or next run prior to the end of the shift.
Meet daily, weekly, and monthly production output goals, product quality, and on-time shipping.
Monitor operations and trigger corrective actions.
Utilize and ensure full adoption of RedZone to track and optimize productivity standards, metrics, and performance targets to ensure operational equipment effectiveness (OEE).
Assign daily, weekly, and monthly production goals to every member of the team and lead people to hit production quotas while meeting all manufacturing guidelines.
Increase production, assets capacity, and flexibility while minimizing unnecessary costs (overtime, yield loss, damages to equipment) and maintaining current quality standards.
Ensure the department is meeting all daily, weekly, and monthly production goals set by management.
Work closely with the Production Manager daily to ensure realistic productivity expectations are met.
Alert management of any case where schedules are not being met or not expected to be met.
Implement strategies in alignment with strategic initiatives and provide a clear sense of direction and focus.
Serve as backup in the absence of the Packaging Manager and coordinate with the Director of Operations on an as-needed basis.
Train for critical succession planning for self and supervisors.
Monitor end-of-day reports and conduct spot checks/audits to keep all machines, instruments, utensils, and packaging area clean.
Document cleaning and operating frequency in accordance with current SOPs, GMPs, and 21 CFR part 111 and part 117.
Ensure staff wear appropriate safety equipment and personal protective equipment.
Remain alert and aware of work operations to avoid accidents and incidents.
Report to Production Manager and take immediate action to correct all actual or potential compliance violations.
Ensure all staff practice established hygienic practices, including wearing appropriate garments (PPE), attending to personal hygiene, hand washing, and sanitization prior to work and at any time during working hours.
Understand the operating requirements of all equipment and ensure staff operate equipment within the requirements set by the equipment manufacturer and management.
Provide proper oversight so no equipment or equipment parts are misused or abused by staff.
Follow up on reports of operator concerns or damages and report to the Supervisor or immediately.
Alert the Production Manager to all concerns of possible contamination, equipment damage, hygiene issues, illnesses, Batch (Work Order) issues, and any other concerns related to Good Manufacturing Practices.
Lead by example and monitor morale and welfare, taking firm and positive actions to maintain good order and discipline.
Monitor and ensure required initial training, annual training, and re-training are completed for all production staff.
Interact with HR to ensure training completed is documented.
Clean and maintain equipment and room.
Perform any other duties as assigned by the Director of Production or other Executive Staff.