Compression Operator Newtown, PA
Responsible for performing tasks to specifications related to oral solid and liquid dose pharmaceutical manufacturing. The process includes tablet manufacturing.
Key Duties and Responsibilities:
• Ensure the proper set-up and operation of standard pharmaceutical process equipment such as Tablet Presses and ancillary equipment (metal detectors, tablet dedusters, friability units, scales).
• Perform all in-process testing, sampling and inspections as required by the Master Batch Record (i.e. tablet thickness, tablet hardness, visual inspection, etc.)
• Should be capable of making machine adjustments during startup, and during in-process testing.
• Checks and inspects operation results against predetermined ranges as per the batch record instructions.
• Clean and sanitize equipment and manufacturing rooms including walls, floors, and ceilings per current SOPs
• Ensure proper execution of Master Batch Records, standard operating procedures and validation protocols.
• Ensure accurate completion of equipment logs.
• Ensure cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP’s).
• Interface and consult with Quality Assurance personnel.
• Identify and report quality issues
• Total compliance at all times by following batch records instructions, SOPs and all company policies
• Report accidents, unsafe conditions or unusual circumstances to supervisor.
• Adhere to all relevant cGMP and FDA regulations.
• Comply with FDA guidelines/Company Policies of Data Integrity
Education and Experience:
• High school diploma or equivalent or technical school certificate
• 1+ year of previous similar working experience
• Excellent written and verbal communication skills
• Excellent math skills
• Ability to read and comprehend SOP’s, Batch Records and training documents.
• Ability to multi-task effectively
• Excellent interpersonal skills and ability to effectively interact with different functional groups
• Must be able to stand for at least an 8-hour shift and lift, push or pull up to 50 pounds.
• Capable of wearing any type of personal protective equipment