Nivagen Pharmaceuticals, Inc.
QA Specialist– Visual Inspection and Packaging
Sacramento, CA 95834
Sponsorship not specified$85k-$95kDetected 22 days ago
AccessibilitySupply ChainGMPFDA RegulatoryCommunicationProblem Solving
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odds of building a lasting career here
50Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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from this employer's Department of Labor filings
Files H-1B transfers
7 transfer filings in the last year, covering 7 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
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About the role
- For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people.
- 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.
- If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.
Responsibilities
- 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.
- Perform packaging material reconciliation and reject verification.
- Identify, document, and support investigation (as applicable), documentation, labeling, packaging, and material discrepancies.
- Perform QA verification of rejected units and packaging components, as applicable.
- Support batch review, discrepancy investigations, and other QA activities associated with visual inspection, packaging, and dispatch operations.
- Ability to work effectively in a fast-paced pharmaceutical manufacturing environment and collaborate with cross-functional teams.
- 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.
Requirements
- Ability to apply sound judgment and make decisions aligned with company procedures and regulatory standards.
- 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.
- Verify issuance, accountability, reconciliation, and proper use of labels, cartons and other packaging materials required for batch packaging as per packaging record.
- Coordinate and verify the collection/removal of retention samples, stability samples, finished product samples, and other required samples.
- Ability to independently perform QA assessments within established procedures and appropriately escalate issues when required.
Nice to have
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, or a related field preferred.
- Experience in pharmaceuticals/Biopharmaceuticals sterile injectable manufacturing is highly preferred.
- Experience supporting FDA Pre-Approval Inspections (PAI) or routine GMP inspections is preferred.
Compensation
- Pay range $85,000 - $95,000 per Year
Benefits
- Yearly bonus eligibility
- Medical, dental and vision coverage
- Paid time off plan
- Nivagen offers a wide variety of benefits and programs to support health and well-being
- Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.
- 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.
Company info
- 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.
Visa & Work Authorization
- iduals 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 s
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