QA Specialist– Visual Inspection and Packaging
An in-process QA Specialist at a pharmaceutical manufacturer who provides real-time quality oversight of visual inspection, packaging, and final dispatch of sterile injectable products — reviewing batch records, performing AQL and label verification, and ensuring cGMP/GDP compliance on the production floor in Sacramento.
- Compensation
- $85K–$95K / yr
- Location
- Sacramento, CA 95834
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- Not specified
- Category
- Qa
- Posted
Must have
- Hands-on experience in In-Process QA, visual inspection, packaging, batch record review, and/or final dispatch in pharmaceutical manufacturing
- Working knowledge of FDA regulations, cGMP, GDP, packaging operations, labeling controls, AQL inspection, material reconciliation, and shipment/dispatch controls
- Strong attention to detail; ability to identify documentation, process, and compliance discrepancies in real time
- Ability to work effectively in a fast-paced environment and collaborate with cross-functional teams
- Strong written and verbal communication skills
- Ability to independently perform QA assessments and escalate issues appropriately
- 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
- Must live or be willing to move to the Sacramento Metropolitan Region (approx. 40 miles radius)
Nice to have
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, or related field
- Experience in pharmaceutical/biopharmaceutical sterile injectable manufacturing
- Experience supporting FDA Pre-Approval Inspections (PAI) or routine GMP inspections
Full description
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.