Manufacturing AssociateProcesses active compound materials into final tablet form performing quality control checks to maintain consistency of product according to manufacturing specifications. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Manufacturing Associate is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities.Obtain and weigh in products for all shifts Moves raw materials and product to/from vault, cage, process or storage areas. Inspects machine parts for unusual wear and proper lubrication. Operates equipment required in the manufacture of pharmaceutical product. Performs/reviews quality checks on weight, thickness, hardness and friability of tablets at various stages of the process according to manufacturing instructions and SOPs. Submits product samples to quality laboratories as required. Maintains product batch, room activity, and equipment records. Maintains control of DEA scheduled material in accordance with accepted policy, practice and procedure.Is at his/her position on the line ready to start production as required. Monitors the production process, makes periodic checks and adjusts equipment or work practices to maximize production efficiency, yields, quality and safety. Accurately reports production and ensures reports are completed as required. Performs operator-level machine adjustments and lubrication. Assists technicians with minor machine repairs and set-up. Troubleshoots problems with equipment and processing to assist other technicians to minimize disruptions to production. Ensures that line conditions are acceptable to change from one product to another by ensuring that materials, paperwork, and equipment have been staged for changeover.Will immediately stop manufacturing and notify Line Leader of any safety or quality concerns. Documents inspections performed and keeps accurate equipment records, clean-up sheets and other required paperwork. Disassembles, cleans and reassembles basic line equipment according to SOPs. Insures proper inspections are conducted prior to reassembly. Cleans and assembles dust collector. Assists in the training of individuals on equipment and processes in the department.Follows all EHS rules and regulations. Accepts accountability for own personal safety and identifies potential unsafe conditions to help prevent self and co-workers from being injured. Complies with all site security requirements. Performs lock-out/tag-out procedures according to SOPs. Follows safe working practices in the execution of their assigned duties. Collects all process related hazardous wastes and transports to accumulation drums. Actively participates in general site and departmental Safety initiatives. Maintains clean work area; clear away debris, damaged or defective product, cartons, labels and packaging supplies.Makes initial attempts to identify root cause within scope of decision-making authority while simultaneously notifying next level of leadership. If attempts at the next level do not resolve the problem and the Associate believes that a higher level needs to be involved, the problem is escalated to the highest level.Assists technicians at other stations within the department as needed. Works on any tableting stations on which you are trained May be crossed-trained in other functionsMinimum RequirementsRequires the basic knowledge and ability to apply mathematical concepts, spelling, reading English, and grammar. Requires a High School diploma or GED.Recommended minimum of three to twelve months' experience under direct supervision and guidance in order to gain sufficient skill to perform the requirements of the position.None RequiredPhysical/Visual Activities or Demands: Physical/visual activities or demands that are commonly associated with the performance of the functions of this job.1. Heavy physical demand requires frequent moving, pushing, pulling, rolling and dumping of up to 100 kg and manual lifting of up to 25 kg. Physical demand also involves walking and standing (70%), balancing, bending, kneeling and reaching (15%), grasping and feeling (5%) and communicating (10%).2. Mental demand is frequent requiring attention to details of specific manufacturing instructions and recording of information on paperwork.3. Visual demand is continuous and requires clarity of vision at 20 inches or less and 20 feet or more with peripheral vision and the ability to bring objects into sharp focus, to judge distance and space relationships and to identify and distinguish colors.Environmental/Atmospheric Conditions: Environmental and atmospheric conditions commonly associated with the performance of the functions of this job.1. Exposure to pure raw materials requires incumbent to wear a respirator on a regular basis.2. Protective clothing and equipment including uniform shirt and slacks, jacket, safety glasses, booties, hairnet, gloves, disposable respirator, hearing protection, PAPR, and tyvek suit are worn continuously in the performance of the job functions.3. Exposure to noise requires incumbent to wear hearing protection on regular basis.4. Work hazards include proximity to moving mechanical parts, exposure to dust, odors, cleaning agents, noise, and vibration.EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.