Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform quality control functions including but not limited to component inspections, in-process inspections and finished product inspections according to established procedures.
• Determine proper in-process test standards and assure compliance to same.
• Perform sampling and inspection of bulk drug and excipients.
• Pull and maintain customer/Sharp Clinical Services reserve samples.
• Perform physical testing using basic inspection instrumentation.
• Perform daily verification activities (temperature, humidity, weight on balances, etc.)
• Change the status of material, GMP areas, equipment, and utensils.
• Determine if in-process test results are within established specifications. Responsible for suspending operations and notifying supervisor of any out of specification results.
• Perform pre-production line clearance to the GMP Area prior to the initiation of production.
• Perform verification of drug product and components against approved Manufacturing Instructions prior to the initiation of production.
• Perform verification on cleaned GMP Areas, equipment and utensils.
• Ensure testing is in adherence to current procedures and sampling plans.
• Ensure compliance with cGMPs and Sharp Clinical Services SOPs during clinical and commercial supply production.
• Maintain accurate, detailed records of work performed.
• Provide timely communication of quality or cGMP issues to supervisor.
• Work with internal staff to meet scheduled requirements in a timely manner.
• Remain accountable for maintaining a clean, orderly, and safe work environment.
• Adhere to set safety standards.
• Participate actively in regular meetings.
• Achieve expected performance measures.
• Perform other duties as assigned.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is frequently required to stand, use hands to finger, handle or feel, reach with hands and arms and talk or hear. The employee is often required to walk or sit. The employee must occasionally lift and/or move up to 30 pounds.

Specific vision abilities required by this job include close, distance, ability to adjust focus, color and depth perception.

ENVIRONMENTAL CONDITIONS

While performing the duties of the job, the employee is occasionally exposed to fumes or airborne particles and is frequently working near moving mechanical parts. The employee is required to wear PPE such as a lab coat, safety glasses, and occasionally an N-95 and PAPR (respirator). The noise level in the work environment is usually moderate.