Duties/Responsibilities:

• Sampling of raw materials, in-process and finished product samples
• Maintain sample request forms and retention samples.
• Review batch manufacturing and packaging records.
• Collect purified water samples as per schedules and send the samples to contract testing laboratories.
• Perform the Annual Product Review data compilation and report preparation.
• Perform the environmental monitoring and purified water trend reports per procedural requirements. 
• Issue and place appropriate labels for containers/samples.
• Review and determine the approval of unit operations to proceed for each stage of the manufacturing process
• Review logbooks for the GMP rooms and equipment.
• Line clearances for the room, equipment and process operations.
• Release the equipment for manufacturing and packaging and review batch records for thoroughness.
• Review documentation and release the rooms/equipment for manufacturing and packaging.
• Assign lot numbers, generate in-house labels and issue manufacturing and packaging records.
• From the QA perspective, participate in and monitor the equipment qualification process – IQ-OQ-PQ and preventive maintenance and calibration of production equipment. 
• Work closely with other departments to meet the timelines for projects.
• Perform other responsibilities as assigned by your supervisor and management.
• 1^st Shift hours are 7:30am – 4:00pm.  2^nd Shift hours are 2:00 – 11:30pm.  Both shifts require employees to work flexible hours, as needed. 

Education, Experience and Skills:

• High School diploma or equivalent.
• 1-2 year’s pharmaceutical industry experience is required. Knowledge of Standard Operating Procedures (SOPs) and a good understanding of GMP documentation in the pharmaceutical industry is a must.
• Good verbal and written communication skills and documentation experience.
• Proficiency with Microsoft Word, Excel and PowerPoint.