GENERAL DESCRIPTION OF POSITION: Tends machines, transfers products into containers, weighs, completes documentation, performs maintenance and monitors and calibrates equipment. Cleans equipment and rooms per SOP’s and monitors product quality by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Responsible for room and equipment readiness prior to start of production. Monitors processes and batch record documentation for compliance with MBR, SOPs and cGMPs during Tableting operations.

1. Follows and enforces safety rules, regulations, and      procedures. Understands and complies with all department MBRs and SOPs in      accordance with cGMPs.
2. Verifies      all batches by control number and weight received and quantity per      specifications prior to running the lot.
3. Starts      the machine and observes operation to ensure all machinery is operating      properly. Stops the machine and reports any malfunction to the tableting      lead. Assists in repairs as required.
4. Performs      set-up of tablet press, assigned preventive maintenance procedures, parts      assembly, and cleaning hardware. Ensures each product is tableted      according to specifications and standard operating procedures.
5. Collects      in-process and finished products for tests at specified stage and tests      for various quality attributes per SOPs and as directed. Inspects and      verifies per MBR’s and SOP’s. Performs in-process quality checks per MBR’s      and SOP’s.
6. Assists      in product failure and customer complaint investigations, verifies      quantities produced on a shift basis. Cleans equipment and room after      completion of specified lots per SOP’s. Performs and documents cleaning of      equipment and room.
7. Assists      the Lead Technician in providing routine standardized direction as      authorized to Technicians. Determines sampling quantities for the      Tableting run based upon theoretical yield.
8. Reconciles      batch records and ensures documentation is accurate and complete.
9. Assists      the Leads in the planning of workflow based on the schedule.
10. Perform any other related duties as      required or assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE: To perform this job successfully, an individual must be able to satisfactorily perform the essential duties summarized above and possess the skills and competencies summarized herein. High school diploma or general education degree (GED) and one to three months related experience and/or training.