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Job Description
In-Process Quality Assurance Personnel NeilMed Pharmaceuticals - 3.1 Santa Rosa, CA Job Details Full-time 8 hours ago Benefits Paid holidays Health insurance Dental insurance 401(k) Vision insurance Paid sick time Qualifications Microsoft Word Microsoft Excel Basic math High school diploma or
GED Full Job Description Category:
QA -
Quality Control Position:
Full Time Type:
Hourly Location:
Santa Rosa
CA COMPANY PROFILE
Ketan C. Mehta, MD and Nina Mehta, founded NeilMed® Pharmaceuticals, Inc. in January 2000 from Dr. Mehta's medical office and in a short span, we have over 500 employees. NeilMed® is the largest manufacturer and supplier of LVLP (Large Volume Low Pressure) saline nasal irrigation systems in the world. The NeilMed® brand of products help alleviate common nasal and sinus symptoms in a simple, safe, effective and affordable way. The company supplies millions of products to end users through various trade channels. Our headquarters & manufacturing facility is based in Santa Rosa, California, USA. In addition to our USA headquarters, we also supply and have offices in multiple countries worldwide . Our unique business model has been a very strict vertical integration, for achieving precision and fast execution at all levels. NeilMed® prides itself in being part of the small community of Santa Rosa, located in the heart of Sonoma County's wine country in Northern California. Our flagship products are NeilMed®
SINUS RINSE
™ and NeilMed® NasaFlo® Neti Pot . These products are available in most stores in the USA, Canada, and several other countries around the world. There are currently over 40 different products for nasal and sinus care, and all are OTC (over the counter). With an extremely dedicated small team of loyal, and hard working leadership group, NeilMed® continues to formulate innovative ideas to market. Additional diversification plans include the introduction of surgical devices for hospitals and emergency rooms. NeilMed® supports medical research in several countries and educating health care professionals and consumers. We believe in excellent 24 hour customer service, helping local communities, and donating for natural disasters.
OUR MISSION
The mission of our company is safety and affordability to sustain long-term growth, creating drug free and effective nasal / sinus care products for millions of consumers worldwide. Job Description The IPQA is responsible for ensuring the quality of materials, in-process components, and fi nished products meet the company's established quality standards and regulatory requirements. This role plays a key part in the quality assurance in process, ensuring compliance with Good Manufacturing Practices (GMP) and all applicable FDA regulations. The IPQA collaborates with the production team to identify and resolve any quality issues, performs detailed inspections, and maintains accurate records to ensure consistency and compliance across the production line. Job Experience
GENERAL DESCRIPTION - DUTIES
Work Order Coordination:
Collaborate with the production department to collect and review work orders, ensuring that all necessary materials and documentation are available before the start of production.
Material Verification & Line Clearance:
Verify that all materials conform to the work order specifications. If discrepancies arise, coordinate with the supervisor to resolve material mismatches. Follow line clearance procedures to ensure a clean and prepared production environment, preventing cross-contamination.
DHR Management & Compliance:
Ensure that all steps are followed accurately and in compliance with GMP. Review completed DHRs for accuracy and completeness.
In Process Inspection and Quality Control:
Collect samples according to the sampling procedure, inspect and send them to the laboratory for further testing as applicable. Verify the finished product and release the pallet. Collect retain samples according to the current procedure. Conduct thorough inspections of first article, in-process & finished products, and packaging to verify they meet defined quality standards and specifications. Make acceptance or rejection decisions based on established criteria.
Compliance:
Record and report any non-compliance observed in the production line to the IPQA lead and recommend corrective actions, as necessary.
Record Keeping & Reporting:
Accurately document all observations, inspection results, and non-conformances and notify the supervisor.
Packaging & Labeling Verification:
Ensure that all packaging and labelling of in-process and finished goods (case and pallet labels) are correct and meet regulatory and company standards before releasing them to the next stage.
Safety & Regulatory Compliance:
Perform all work under internal safety protocols, GMP, and FDA regulations, ensuring the manufacturing environment meets the highest compliance standards. Other duties as assigned. Job Experience
GENERAL DESCRIPTION - DUTIES
Work Order Coordination:
Collaborate with the production department to collect and review work orders, ensuring that all necessary materials and documentation are available before the start of production.
Material Verification & Line Clearance:
Verify that all materials conform to the work order specifications. If discrepancies arise, coordinate with the supervisor to resolve material mismatches. Follow line clearance procedures to ensure a clean and prepared production environment, preventing cross-contamination.
DHR Management & Compliance:
Ensure that all steps are followed accurately and in compliance with GMP. Review completed DHRs for accuracy and completeness.
In Process Inspection and Quality Control:
Collect samples according to the sampling procedure, inspect and send them to the laboratory for further testing as applicable. Verify the finished product and release the pallet. Collect retain samples according to the current procedure. Conduct thorough inspections of first article, in-process & finished products, and packaging to verify they meet defined quality standards and specifications. Make acceptance or rejection decisions based on established criteria.
Compliance:
Record and report any non-compliance observed in the production line to the IPQA lead and recommend corrective actions, as necessary.
Record Keeping & Reporting:
Accurately document all observations, inspection results, and non-conformances and notify the supervisor.
Packaging & Labeling Verification:
Ensure that all packaging and labelling of in-process and finished goods (case and pallet labels) are correct and meet regulatory and company standards before releasing them to the next stage.
Safety & Regulatory Compliance:
Perform all work under internal safety protocols, GMP, and FDA regulations, ensuring the manufacturing environment meets the highest compliance standards. Other duties as assigned.
Skills & Requirements Education:
High School diploma (GED) required. An associate's degree in a related fi eld is preferred.
Experience:
1-3 years of experience in quality control, inspection, or a related role within a regulated industry (pharmaceutical, medical device, or food production) is preferred.
Skills & Abilities:
Bilingual is preferred. Excellent attention to detail with strong observational skills. Basic proficiency in Microsoft Offi ce Suite (Excel, Word). Good mathematical skills for basic calculations. Strong organizational and multitasking abilities, with a commitment to meeting quality standards.
Problem-Solving:
Ability to quickly identify and resolve quality-related issues, working collaboratively with the production department.
Work Ethic:
Strong work ethic with a commitment to producing high-quality products while maintaining compliance with all relevant regulations and standards.
Benefits:
Medical, Dental, and Vision 401k Holiday and Sick pay Vacation pay
