Compression Operator

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