Quality Assurance (QA) Inspector - 1st & 2nd Shift

I3pharmaceuticals; Warminster Township (Bucks County); Sur place; USD 42 000 - 64 000; Plein temps

Résumé du poste

I3pharmaceuticals is seeking a Quality Assurance (QA) Inspector for 1st and 2nd shifts in Warminster Township, PA. This role focuses on sampling, batch review, environmental monitoring, labeling, and release activities to ensure GMP compliance.

Ideal candidates will have 1–2 years in the pharmaceutical industry, strong SOP/GMP knowledge, and proficiency with Microsoft Office. Flexibility to cover shifts and collaborate with multiple departments is required.

Qualifications

• 1-2 years of pharmaceutical industry experience required.
• SOPs and GMP documentation knowledge in the pharma industry is a must.
• Good verbal and written communication and documentation experience.
• Proficiency with Microsoft Word, Excel and PowerPoint.

Responsabilités

• 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 and send to contract testing labs.
• Perform Annual Product Review data compilation and report preparation.
• Perform environmental monitoring and purified water trend reports per procedures.
• Issue and place appropriate labels for containers/samples.
• Review and approve unit operations to proceed for each manufacturing stage.
• Review logbooks for GMP rooms and equipment.
• Line clearances for rooms, equipment and process operations.
• Release equipment for manufacturing and packaging and review batch records.
• Review documentation and release rooms/equipment.
• Assign lot numbers, generate in-house labels and issue records.
• Participate in equipment qualification (IQ-OQ-PQ) and calibration.
• Work with other departments to meet project timelines.
• Perform other responsibilities as assigned by supervisor/management.

Connaissances

Sampling

Documentation

Communication

Microsoft Office

Formation

High School diploma

Outils

Microsoft Word

Excel

PowerPoint

Description du poste

Quality Assurance (QA) Inspector - 1st & 2nd Shift

Posted Date : [ Jul 15, 2026 ]

Duties/Responsibilities:

• Sampling of raw materials, in-process and finished product samples
• Maintain sample request forms and retentionsamples.
• Review batch manufacturing and packaging records.
• Collect purified water samples as per schedulesand send the samples to contract testing laboratories.
• Perform the Annual Product Review datacompilation and report preparation.
• Perform the environmental monitoring andpurified water trend reports per procedural requirements.
• Issue and place appropriate labels forcontainers/samples.
• Review and determine the approval of unitoperations to proceed for each stage of the manufacturing process
• Review logbooks for the GMP rooms and equipment.
• Line clearances for the room, equipment andprocess operations.
• Release the equipment for manufacturing andpackaging and review batch records for thoroughness.
• Review documentation and release therooms/equipment for manufacturing and packaging.
• Assign lot numbers, generate in-house labels andissue 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 thetimelines for projects.
• Perform other responsibilities as assigned byyour 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 pharmaceuticalindustry is a must.
• Good verbal and written communication skills anddocumentation experience.
• Proficiency with Microsoft Word, Excel and PowerPoint.