QA Specialist: Visual Inspection & Packaging Excellence

Nivagen Pharmaceuticals Inc; Sacramento (CA); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Yearly bonus eligibility

Medical, dental and vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals Inc in Sacramento, CA seeks a QA Specialist for Visual Inspection and Packaging to ensure GMP compliance during manufacturing. You will oversee in-process QA, packaging, record review, and final dispatch, ensuring accurate labeling, material reconciliation, and adherence to GDP and cGMP.

The role requires hands-on QA experience in sterile injectable manufacturing, strong attention to detail, and effective cross-functional collaboration.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, or a related field preferred.
• Hands-on experience in In-Process QA, visual inspection, packaging, batch record review, and/or final dispatch activities within a pharmaceutical manufacturing environment.
• Experience in pharmaceuticals/Biopharmaceuticals sterile injectable manufacturing is highly preferred.
• Working knowledge of FDA regulations, cGMP, GDP, packaging operations, labeling controls, AQL inspection, material reconciliation, and shipment/dispatch controls.
• Strong attention to detail with the ability to identify documentation, process, and compliance discrepancies in real time.
• Ability to work effectively in a fast-paced pharmaceutical manufacturing environment and collaborate with cross-functional teams.
• Strong written and verbal communication skills.
• Ability to independently perform QA assessments within established procedures and appropriately escalate issues when required.
• Experience supporting FDA Pre-Approval Inspections (PAI) or routine GMP inspections is preferred.

Responsibilities

• Provide real-time QA oversight during visual inspection, secondary and tertiary packaging, and final dispatch operations for sterile injectable products.
• Perform real-time review and verification of batch manufacturing and packaging records during execution.
• Perform and document the AQL visual inspections in accordance with approved procedures and sampling requirements.
• Perform artwork verification and review/approval of labelling and packaging components, including specimen labels and printing details.
• Verify issuance, accountability, reconciliation, and proper use of labels, cartons and other packaging materials required for batch packaging as per packaging record.
• Perform packaging material reconciliation and reject verification.
• Verify line clearance and area readiness prior to applicable visual inspection and packaging activities.
• Identify, document, and support investigation (as applicable), documentation, labeling, packaging, and material discrepancies.
• Coordinate and verify the collection/removal of retention samples, stability samples, finished product samples, and other required samples.
• Provide QA oversight during final dispatch activities, including verification of applicable product, labeling, packaging, shipment, and dispatch documentation prior to release for shipment.

Skills

Attention to detail

Communication skills

Cleanroom gowning

Analytical thinking

Education

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, or related field

Job description

Nivagen Pharmaceuticals Inc in Sacramento, CA seeks a QA Specialist for Visual Inspection and Packaging to ensure GMP compliance during manufacturing. You will oversee in-process QA, packaging, record review, and final dispatch, ensuring accurate labeling, material reconciliation, and adherence to GDP and cGMP.

The role requires hands-on QA experience in sterile injectable manufacturing, strong attention to detail, and effective cross-functional collaboration.