QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES: Good understating of cross-contamination, personal hygiene and GMP's Good written/verbal skills Follow all applicable safety guidelines/rules. Use required PPE equipment when necessary. EDUCATION AND EXPERIENCE: Minimum of High School Diploma required and at least 2 years Compounding experience in cGMP/Pharmaceutical manufacturing in a process environment 1-3 Years’ in Pharmaceutical pharmacy experience in batch preparation. JOB PREREQUISITES: Ability to meet attendance standards.
All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines. Must work with users at all levels within company and vendors outside of company Must be able to problem solving on a daily basis PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT Mental Requirements include: Ability to hear accurately the spoken word with moderate office noise or plant noise Ability to apply deductive reasoning and understand complicated issues Ability to receive instructions and follow work rules and company policies Ability to follow safety and security practices Ability to meet deadlines and effectively deal with office stress Ability to accurately communicate ideas, facts and technical information Maintain confidentiality of certain information
SUMMARY: Following set manufacturing instruction procedures (MPCRs), SOPs and cGMP guidelines, utilized compounding tanks, kettles, transfer pumps, mixers and mills to mix and compound raw materials used in the manufacturing of pharmaceutical products. Perform daily cleaning/sanitation of the compounding department, compounding tanks, kettles, pumps and other equipment used in the manufacturing of pharmaceutical products. ESSENTIAL FUNCTIONS: Include the following. Other duties may be assigned. Following MPCRs, SOPs and establish cGMP practices to manufacture pharmaceutical batches utilizing the various compounding tanks, kettles, transfer pumps, mixers and mills. Using scales, automated dispensing systems weigh out specified types and quantities of liquid ingredients according to a formula. Collect water samples for laboratory analysis from various equipment, water ports that will be utilized in compounding the batch. Perform daily cleaning/sanitation of the compounding department and the various equipment used in manufacturing of the batches. Performs all batch record documentations, JDE inventory transactions and final bulk confirmations. Extract bulk samples for laboratory analysis after completion of the batch compounding. Utilized transfer pumps and the filling station distribution system, transfer batch to the various filling lines.