GMP Operator I

  The Role  The GMP Operator I is an entry-level role responsible for manufacturing drug products in compliance with current Good Manufacturing Practice (cGMP) standards. This position involves following all applicable Standard Operating Procedures (SOPs) and Batch Records to ensure product quality and regulatory compliance. The role reports directly to the GMP Area Supervisor and operates within GMP manufacturing environments at our Philadelphia sites (Boothwyn and Garnet Valley).   Main tasks and responsibilities Weighing and manufacturing of GMP, R&D, clinical and commercial batches (i.e., dispensing, granulation, drying, milling, blending, compression, encapsulation, and bulk packaging operations) Operate, clean, and sanitize equipment and production rooms as per SOP's, protocols, cleaning records.  Performance verification of scales and balances prior to use. Prepare documentation and submit samples collected during manufacturing to the appropriate departments as needed.  Assure manufacturing department is always neat and clean by end of shift.  Participates in process and cleaning validation activities as required.  Notify the GMP Coordinator or Supervisor to ensure supplies are kept in stock. Follow all GMP rules as states in SOPs pertaining to use of the Manufacturing Area.  Execution of GMP, R&D and Clinical batch records with minimal or no supervision Ensure training is within compliance for all activities you are assigned prior to execution of any assigned tasks. Adherence to schedule to support deadlines, willingness to work outside of normal shift (overtime) as needed.   Qualifications and Experience Required for Competent Performance HS diploma (GED)with some experience of GMP manufacturing or equipment maintenance/ calibration is preferred. Competent in the use of Microsoft Office packages including Word, Excel, and windows operating systems preferred. Experience and knowledge of cleaning within a GMP regulated environment/ department is preferred. Experience of working in a pharmaceutical analytical/ manufacturing environment or equivalent experience in another role is preferred. Read and interpret documents such as safety rules, equipment operating and maintenance instructions, and standard operating procedures and material safety data sheets. Ability to apply concepts such as fractions, percentages, ratios, rounding and proportions to practical solutions is preferred. Proficient in the use of a calculator, ability to work independently in a diverse and fast paced environment. Good decision-making skills and ability to multi-task. Spatial management Organization skills Ability to interpret and carry-out instructions, Maintains a Professional appearance, demeanour.   Work Schedule M-F 07:00 – 15:30 (first shift) M-F 15:00-23:30 (second shift) This role is classified as Non-Exempt   Physical Demands  While performing the duties of this job, the employees are frequently required to stand, walk, use of hands to find, handle or feel, smell, and talk or hear. Employee should be able to pull/push equipment for cleaning. Employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel and crouch. Employee must occasionally lift and/or move up to 50 pounds. Must be able to qualify for respiratory protective equipment use.