2nd shift Production Lead

The Process Lead, acting under minimal supervision, will develop and lead a cohesive multi-functional work team(s) to produce a quality product in a safe and efficient manner while adhering to all compliance standards. He/she oversees all phases of clinical packaging, labeling, manufacturing, and assembly of investigational drug product that includes but is not limited to blistering, bottling, carding, encapsulation, manufacturing, labeling, and assembly. Directs and supports teams to execute clinical and commercial processes to meet production objectives in accordance with SOPs and cGMP requirements.Essential Duties and Responsibilities Over sees Production Areas assigned by the Supervisor.Creates and reviews supporting documentation associated with the packaging operation(s) being performed. i.e., Batch Records, forms, etc.SME (Subject Matter Expert) in multiple areas. Creates Four Phase Training documentation, Trains peers and subordinates, and shares job knowledge.SAP (Inventory Management Systems).Create and revise SOPs.Assist in quality-related investigations.Continuous Improvement Leader (Drive change through data metrics).Work with fellow Leads to allocate staff according to scheduled priorities.Operate, set-up, adjust packaging equipment.Perform system challenges, in process inspections, and clinical start up activities.Ensure your area is in adherence to all safety standards outlined in governing SOPs.Ensure your areas is in adherence to all housekeeping standards outlined in governing SOPs.Monitor Material Replacement Order (MRO) supplies.Adhere to set safety standards.Participate actively in regular meetings.Achieve expected performance measures.Other duties as assigned by the Production Supervisor Attributes and Competencies To perform this job successfully, an individual must possess certain qualities and characteristics to perform each essential duty satisfactorily. Blow are listed the traits and behaviors required. Behavioral Sense of urgencySelf-motivatedAbility to adapt to changeTeam player, can work as part of a teamCommunicates effectively, both orally and in writingDemonstrated ability to provide direction/set clear expectations to Process Technicians working in assigned room/on assigned line.Proactive in learning new tasks, demonstrates interest in self-improvementTechnical Good basic mathematical skillsUnderstanding of cGMPsMechanical aptitudeQualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.High School diploma or general education degree (GED) equivalent.3-5 years of previous as a Process Technician 2 or equivalent experience at a Pharmaceutical/Clinical or cGMP regulated facility.Experience leading teams in a production environment.Thorough knowledge of production equipment and processes including granulation compression, encapsulations, blistering, bottling, etc.Prior experience leading teams in a production environment.Must be able to speak, read, comprehend and write in English.Computer skills; email, Microsoft Office Work and Excel.Communicates effectively.Must be able to gown and work in PPE (Personal Protective Equipment) including but not limited to: safety shoes, safety glasses, respirators, full hooded suits (worn over the head and face), as required by SOPsAble to work with Controlled Substances (Must successfully pass Criminal background check and drug screening.).Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to stand for long periods of time.Employee must have excellent dexterity.The employee must frequently lift and/or move up to 50 pounds (unassisted).Must be able to bend, reach and stretch.Ability to work in tight spaces.Able to work in cold environments for extended periods of time. Excellent vision (with or without the assistance of glasses or contact lenses). Environmental Conditions While performing the duties of the job, the employee is occasionally working near moving mechanical parts and exposed to fumes or airborne particles. The noise level in the work environment is usually moderate.