Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Job Summary:

We are seeking a dedicated individual to lead process and quality improvements in our manufacturing and packaging department. This role involves identifying and implementing strategies to enhance efficiency, reduce waste, and boost operational output. You will be responsible for conducting root cause analyses, determining corrective actions, and fostering a culture of continuous improvement.

Key Responsibilities:

The role includes actively improving processes to achieve high-quality standards, eliminating waste, and meeting departmental goals. You will collaborate with management to identify and implement new opportunities for improvement in quality, cost, performance, and maintenance. Evaluating current processes and performance metrics to identify areas for improvement and optimize process capabilities is essential. Leading the quality response process, including initial response, containment, root cause investigation, and corrective actions, is a key part of the job. You will apply strong problem-solving skills to address issues related to formulations, equipment, and processes. Facilitating the implementation of new or improved processes, including training crews on night and weekend shifts as needed, is required. Representing the production department in various project teams and meetings is also part of the role. You will aid in the creation and upkeep of quality and training initiatives and coordinate with Project Management, Facility/Equipment Schedulers, Materials Management, Analytical Development, and other areas to achieve project goals. Maintaining a deep understanding of pharmaceutical processes, equipment, and procedures is crucial.

Job Scope:

This role offers an outstanding opportunity to build the future of our production processes, ensuring we uphold world-class standards and compete effectively in the market!

Education and Experience:

A high school diploma with 2 years of experience in manufacturing and/or quality systems is required. Knowledge of lean manufacturing tools, PPI (Practical Process Improvement) desired. Combinations of education, training, and relevant work experience may be considered.

Proficiencies:

A strong understanding of Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP), and safety standards is essential. Excellent organizational, documentation, and housekeeping skills are required. The ability to work independently and as part of a team with limited supervision is necessary. Proficiency in computer use and excellent written and oral communication skills are important. The ability to lift up to 50 lbs and perform job requirements while wearing Personal Protective Equipment (PPE) is required.

Physical Requirements:

Moderate physical exertion is required, including lifting medium weight objects, bending, crouching, stretching, and reaching. Frequent operation of equipment, including keyboards, and prolonged periods of walking, sitting, or standing are necessary. Regular exposure to factors causing moderate physical discomfort, such as dust, fumes, or odors, is expected. Safety precautions, including the use of PPE, may be necessary.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.