QA Specialist- Visual Inspection and Packaging

About the Company:

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Job Location:

Nivagen Pharmaceuticals, Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Title of the Position: QA Specialist– Visual Inspection and Packaging

At Nivagen as an In Process QA Specialist you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements.

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.
• Perform QA verification of rejected units and packaging components, as applicable.
• 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.
• Verify that applicable batch, shipment, and dispatch records are complete, accurate, and appropriately reconciled prior to final dispatch.
• Ensure product and associated materials are appropriately identified, accounted for, and released in accordance with approved procedures.
• Review executed documentation for completeness, accuracy, traceability, and compliance with GDP and cGMP requirements.
• Work closely with Manufacturing, Packaging, QC, Warehouse, Supply Chain, and other cross-functional teams to ensure timely resolution of QA-related issues.
• Support batch review, discrepancy investigations, and other QA activities associated with visual inspection, packaging, and dispatch operations.
• Ensure compliance with 21 CFR 211.192 (Checking Operations) and ALCOA+ data integrity principles in all batch record review activities.
• Ensure all activities are performed in accordance with approved SOPs, batch records, specifications, and applicable regulatory requirements.

Qualifications & Experience

• 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.

Job Requirements:

* Physical / Mental Requirements

* Ability to apply sound judgment and make decisions aligned with company procedures and regulatory standards.

* Strong analytical and problem-solving skills.

* Ability to gown and work within controlled cleanroom environments.

* Must be able to wear appropriate PPE (safety shoes, glasses, gloves, etc.).

* Ability to stand for extended periods during manufacturing oversight activities.

Work Environment / Schedule

· Primarily day shift, Monday–Friday.

· May require flexibility to support manufacturing operations, including occasional off-shift or weekend coverage.

· Work Location Assignment: On-site / Manufacturing Facility

·This role requires spending significant time on the production floor, monitoring processes, and conducting tests in a cleanroom or controlled environment
·Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius)

Benefits:

• Pay range $85,000 - $95,000 per Year
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
• Medical, dental and vision coverage
• Paid time off plan

Additional Information:

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.