Assistant Packaging Manager

Direct Digital LLC•West Valley City, UT

About The Position

Job Duties & Responsibilities: Reads and reviews the Batch Records (Work Orders) prior to job start-up, to identify and understand all production, validation, and/or special requirements. Determines the placement of personnel on the production line, according to quality critical skill sets required at each line station. Verifies Line clearance and completes required Line clearance and Cleaning Logs prior to start-up. Checks all incoming components against the batch record to verify that they are correct. Documents receipts in the batch record. Ensures start-up and in-process quality inspections, testing and sampling. 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 completes all qualified challenges on a production line. Confirms set up of equipment to run product to specification. Monitor the equipment performance during packaging. Overseeing assembly packaging specialists. Ensure that WO’s are completed on time. (Requires collaboration with other departments). Identifying and resolving packaging problems in a timely manner. Conducting daily huddles; communicating challenges to Packaging Manager, Maintenance and Quality. Preparing Work Order(s) (i.e.- components) for next shift and/or next run prior to end of shift. Responsible for meeting daily, weekly, and monthly production output goals, product quality and on-time shipping. Monitors operations and triggers corrective actions. Utilizes, and ensures full adoption of RedZone (i.e., understanding and training team) to track and optimize productivity standards, metrics, and performance targets to ensure operational equipment effectiveness (OEE). Assigns daily, weekly, and monthly production goals to “every” member of the team and is capable of leading people to hit production quotas, while meeting all manufacturing guidelines. Increases production, assets capacity and flexibility while minimizing unnecessary costs (overtime, yield loss, damages to equipment) and maintaining current quality standards. Ensures that department is meeting all daily, weekly, and monthly production goals set by management. Works closely with Production Manager daily, to ensure realistic productivity expectations are met. Alerts management of any case where schedules are not being met or not expected to be met. Implements strategies in alignment with strategic initiatives and provide a clear sense of direction and focus. In the absence of the Packaging Manager serves as the backup and coordinates with the Director of Operations on an as needed basis. Trains for critical succession planning for themself and their supervisors. Monitors end of day reports and conducts spot checks/audits to keep all machines, instruments, utensils, and packaging area clean. Documents cleaning and operating frequency in accordance with current SOPs, GMPs, and 21 CFR part 111 and part 117. Ensures staff wear appropriate safety equipment and personal protective equipment. Remains alert and aware of work operations to avoid accidents and incidents. Reports to Production Manager and takes immediate action to correct all actual or potential compliance violations. Ensures all staff practice established hygienic practices to include wearing of appropriate garments (PPE), attends to personal hygiene, hand washing and sanitization prior to work and at any time during working hours. Understands the operating requirements of all equipment and ensures that staff are operating the equipment within the requirements set by equipment manufacturer and management. Provides proper oversight so no equipment or equipment parts are misused or abused by staff. Follows up on reports of operator concerns or damages and reports to the Supervisor and/or immediately. Alerts the Production Manager all concerns of possible contamination, equipment damage, hygiene issues, illnesses, Batch (Work Order) issues and any other concerns that relate to Good Manufacturing Practices. Leads by example and monitors morale and welfare, taking firm and positive actions to maintain good order and discipline. Monitors and ensures required initial training is accomplished, annual training, and re-training is completed for all production staff. Interacts with HR to ensure training completed is documented. Clean and maintain equipment and room. Performs any other duties as assigned by the Director of Production or other Executive Staff.

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

Reads and reviews the Batch Records (Work Orders) prior to job start-up, to identify and understand all production, validation, and/or special requirements.
Determines the placement of personnel on the production line, according to quality critical skill sets required at each line station.
Verifies Line clearance and completes required Line clearance and Cleaning Logs prior to start-up.
Checks all incoming components against the batch record to verify that they are correct. Documents receipts in the batch record.
Ensures start-up and in-process quality inspections, testing and sampling. 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 completes all qualified challenges on a production line.
Confirms set up of equipment to run product to specification.
Monitor the equipment performance during packaging.
Overseeing assembly packaging specialists.
Ensure that WO’s are completed on time. (Requires collaboration with other departments).
Identifying and resolving packaging problems in a timely manner.
Conducting daily huddles; communicating challenges to Packaging Manager, Maintenance and Quality.
Preparing Work Order(s) (i.e.- components) for next shift and/or next run prior to end of shift.
Responsible for meeting daily, weekly, and monthly production output goals, product quality and on-time shipping.
Monitors operations and triggers corrective actions.
Utilizes, and ensures full adoption of RedZone (i.e., understanding and training team) to track and optimize productivity standards, metrics, and performance targets to ensure operational equipment effectiveness (OEE).
Assigns daily, weekly, and monthly production goals to “every” member of the team and is capable of leading people to hit production quotas, while meeting all manufacturing guidelines.
Increases production, assets capacity and flexibility while minimizing unnecessary costs (overtime, yield loss, damages to equipment) and maintaining current quality standards.
Ensures that department is meeting all daily, weekly, and monthly production goals set by management.
Works closely with Production Manager daily, to ensure realistic productivity expectations are met. Alerts management of any case where schedules are not being met or not expected to be met.
Implements strategies in alignment with strategic initiatives and provide a clear sense of direction and focus.
In the absence of the Packaging Manager serves as the backup and coordinates with the Director of Operations on an as needed basis.
Trains for critical succession planning for themself and their supervisors.
Monitors end of day reports and conducts spot checks/audits to keep all machines, instruments, utensils, and packaging area clean. Documents cleaning and operating frequency in accordance with current SOPs, GMPs, and 21 CFR part 111 and part 117.
Ensures staff wear appropriate safety equipment and personal protective equipment. Remains alert and aware of work operations to avoid accidents and incidents. Reports to Production Manager and takes immediate action to correct all actual or potential compliance violations.
Ensures all staff practice established hygienic practices to include wearing of appropriate garments (PPE), attends to personal hygiene, hand washing and sanitization prior to work and at any time during working hours.
Understands the operating requirements of all equipment and ensures that staff are operating the equipment within the requirements set by equipment manufacturer and management. Provides proper oversight so no equipment or equipment parts are misused or abused by staff.
Follows up on reports of operator concerns or damages and reports to the Supervisor and/or immediately.
Alerts the Production Manager all concerns of possible contamination, equipment damage, hygiene issues, illnesses, Batch (Work Order) issues and any other concerns that relate to Good Manufacturing Practices.
Leads by example and monitors morale and welfare, taking firm and positive actions to maintain good order and discipline.
Monitors and ensures required initial training is accomplished, annual training, and re-training is completed for all production staff. Interacts with HR to ensure training completed is documented.
Clean and maintain equipment and room.
Performs any other duties as assigned by the Director of Production or other Executive Staff.