Job Description
Job DescriptionJob Title: QA Manufacturing Inspector – 2nd Shift
Job Location: Fall River, MA (On-site)
Job Type: Full-Time | Non-Exempt
Shift Timing: Second Shift | 03:00 PM – 11:30 PM (flexible as per business needs)
Industry: Pharmaceutical Manufacturing
Experience Required: 3–15 Years
Relocation: Not Available
Remote Option: Not Available
Travel: Not Required
Job Overview:
We are currently hiring a Quality Assurance Inspector to join our manufacturing quality operations team. This individual will ensure that manufacturing practices and product quality meet required standards during all production phases. The role involves floor-level inspection, testing, and documentation in alignment with cGMP and internal SOPs.
Key Responsibilities:
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Conduct routine in-process quality checks such as weight, hardness, thickness, disintegration, friability, etc.
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Perform room and equipment clearance inspections before and after production stages.
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Execute sampling and inspections based on Acceptable Quality Limits (AQL).
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Collect product samples for quality testing and ensure proper documentation for lab submissions.
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Maintain verification logs of balances, weights, and instruments used during inspections.
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Manage segregation and documentation of rejected batches/materials.
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Monitor environmental conditions across manufacturing areas.
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Assist in reviewing equipment calibration, pest control records, temperature logs, and maintenance reports.
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Review production documentation for completeness and ensure yields/reconciliation accuracy before moving to next steps.
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Perform complaint sample testing and submit detailed reports.
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Report deviations, discrepancies, or non-compliance issues to QA leadership.
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Participate in assigned improvement projects or additional QA activities as needed.
Required Qualifications:
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Minimum Education: High school diploma required; vocational training or associate degree in pharma or industrial production preferred.
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Experience: At least 3 years in a GMP-regulated pharmaceutical manufacturing QA role.
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Dosage Forms: Preferred exposure to inhalation products (MDI); experience with tablets, capsules, liquids, and solids also acceptable.
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Systems & Tools: Working knowledge of Microsoft Office, ERP (e.g., SAP), and documentation practices.
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Communication: Must be fluent in spoken and written English.
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Compliance: Strong understanding of current Good Manufacturing Practices (cGMPs) and standard operating procedures (SOPs).
Desired Skills:
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High attention to detail with ability to multitask and manage timelines.
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Strong communication, organizational, and documentation skills.
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Ability to work independently with minimal supervision on the production floor.
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Team-oriented mindset and willingness to support cross-functional operations.
Note:
Candidates must have a pure pharmaceutical manufacturing background (not biotech).
Experience with MDI is a strong plus but not mandatory. Candidates with experience in other dosage forms such as solids, liquids, tablets, or capsules will be considered.