Job Summary:

This position functions primarily in a controlled non-classified (CNC) environment and requires the individual to wear appropriate PPE. This position will provide leadership to support the successful completion of all CNC tasks, including visual inspection, labeling, packaging, and other duties, such as cleaning, restocking, and waste destruction, as required and/or assigned.

All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies, and any other quality or regulatory (Ex, OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including overtime and/or weekends, may be required.

Responsibilities:

Provide support and leadership for all CNC activities, including visual inspection, labeling, packaging, waste destruction, material transfer, and facility cleaning.
Train production personnel to perform visual inspection, labeling, packaging, waste destruction, facility cleaning, and all other applicable tasks per batch records, WIs, and SOPs.
Responsible for daily team assignments and efficiency tracking for all CNC tasks.
Analyze production efficiencies, downtime, and waste. Lead and encourage teams to improve results and production output.
Maintain production schedule tracking, batch record status updates, and passdowns. Ensure batches are completed, reviewed, and ready for release in a timely manner.
Assist the production supervisor with personnel and conflict management.
Serve as Subject Matter Expert (SME) in all CNC activities:
Qualified to perform all CNC activities (visual inspection, labeling, cleaning, etc.) as required and/or assigned.
Qualified to operate, perform changeover, and perform routine maintenance activities for all labeling and visual inspection equipment.
Demonstrates advanced troubleshooting skills and the ability to make recommendations and collaborate on solutions for resolving issues.
Work collaboratively with support departments to ensure production efficiency and timely batch release:
Interface with warehouse and other support departments as needed to ensure adequate levels of production components and supplies are maintained.
Coordinate with Quality to quickly resolve any batch-related issues, deviations, or document errors.
Participate in the DCO process and deviation initiation/investigation process as required or assigned.
Provide support for technical teams, such as engineering and facilities, as required.

Required Skills/Abilities: (examples)

Arrive for work on time, prepared to work in the CNC environment for the majority of each shift.
Provide strong leadership and effective communication to develop and maintain a diverse and high-performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site processes to create a safe work environment.
Exemplify hands-on leadership by actively participating in all CNC processes. Work with the production team to create a culture of support, positivity, productivity, and continuous improvement.
Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions.
Ensure patient safety by understanding you and your team’s impact on product quality.
Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.
Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation.

Education and Experience:

High School Diploma or equivalent.
5+ years of general work experience.
Prior cGMP experience: 2+ years preferred.
Knowledge of FDA guidelines, cGMP, and GDP.
Knowledge of basic arithmetic and chemistry calculations.
Must speak, write, and read English.
Must be a team player.
Must have excellent attention to detail.

Physical Requirements:

Prolonged periods of standing and time on your feet.

Periods of sitting at a desk and working on a computer.

Must be able to lift up to 50 pounds at times.

The application window for this position is anticipated to be open at least 25 days

Working hours are Tuesday - Friday, 3:00pm - 1:30am.

Learn more about this Employer on their Career Site

Visual Inspection & Labeling Lead