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Job 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 Inc., Sacramento, CA 3050 Fite Circle, Suite 100, Sacramento, CA 95827 About the Job: Title of the Position: Senior Chemist (Full Time) At Nivagen as a Senior Chemist you will be responsible to leads projects, ensuring accurate results, innovative solutions, and optimized processes. This role involves collaborating with engineering, production, and quality assurance teams to support product development, testing, and compliance. Responsibilities: • Communicate with CMO regarding analytical activities., • Handle product deficiencies., • Ensure adherence to FDA guidelines and regulations., • Responsible for maintaining cleanliness of lab areas., • Guide team regarding analytical method development on instruments like HPLC and GC., • Ensure compliance with quality system., • Train new personnel., • Prepare analytical budget for the lab., • Plan analyses in accordance with production schedule., • Develop analytical methods., • Perform PDR-related activities and documentation, • Investigate OOT and OOS results., • Prepare and review SOPs., • Prepare and review COAs., • Prepare other documents related to analytical activities, including protocols, templates, reports, specifications, and STPs., • Review validation protocols, reports, and datasheets. Education/Experience: • Bachelor's degree in Chemistry, Biochemistry, or a related field (Master's or Ph.D. preferred)., • Proficiency in advanced analytical techniques such as spectroscopy, chromatography (HPLC, GC), and other instrumentation., • In-depth understanding of chemical properties, reaction mechanisms, and regulatory guidelines (e.g., FDA, EPA, OSHA)., • Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS)., • Strong problem-solving, communication, and project management skills., • Pay range $75,000-$85,000 per Year, • Yearly bonus and stock options 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 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.

Job 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 Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: QC Chemist As a QC chemist at Nivagen you will be responsible for conducting analytical tests on pharmaceutical products, ensuring that they meet regulatory standards such as those set by the FDA and ICH. This role involves performing tests on raw materials, intermediates, and finished dosage forms to guarantee product safety, efficacy, and quality in compliance with Good Manufacturing Practices (GMP) and other regulatory standards. Responsibilities: • Operate and maintain analytical instruments such as GC, GC-MS, LC-MS, UPLC, and HPLC, which are equipped with UV-Vis, PDA, and CAD detectors., • Ensure proper calibration and regular maintenance of laboratory equipment to guarantee accuracy and precision in results., • Assist in developing and validating analytical methods for new products, ensuring compliance with regulatory guidelines, including those from ICH and FDA., • Perform qualitative and quantitative analyses on raw materials, in-process materials, and finished products using validated methods to ensure compliance with required specifications., • Conduct stability studies on products following ICH guidelines, adhering to stability protocols, and documenting results for regulatory submissions., • Investigate deviations and out-of-specification (OOS) results, conduct root cause analysis, and implement corrective and preventive actions (CAPA) to address and prevent recurrence., • Ensure all testing adheres strictly to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulatory standards., • Implement ICH Q2 (R1) guidelines for method validation and participate in internal and external audits to maintain laboratory compliance., • Collaborate with R&D, production, and quality assurance teams to support product development and commercialization efforts, and provide assistance during regulatory inspections. Education/Experience: • Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field., • Proficiency in analytical techniques (HPLC, GC, FTIR, UV-Vis, Dissolution Testing, etc.)., • Strong understanding of pharmaceutical regulations (FDA and ICH)., • Experience with GMP, GLP, and GDP requirements., • Ability to troubleshoot analytical issues and conduct root cause analysis., • Strong communication and documentation skills., • Excellent attention to detail and organizational skills., • Familiarity with FDA, ICH guidelines, including ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients) and ICH Q10 (Pharmaceutical Quality System)., • Knowledge of stability testing guidelines, including ICH Q1A., • Ability to stand and work for extended periods in a laboratory environment., • Pay range $75,000-$85,000 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 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.

Job 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 Type: Full Time Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA About the Job: Title of the Position: Senior Scientist - Formulation Development We are seeking a highly skilled and experienced Senior Scientist to join our Formulation Development team. The successful candidate will play a critical role in the development and optimization of drug formulations from early-stage research through commercialization. This position requires a deep understanding of formulation principles, a strong scientific background, and a proven track record of success in the pharmaceutical industry. Responsibilities: • Lead the design, development, and optimization of complex injectable and sterile dosage forms., • Develop and implement robust formulation development strategies aligned with regulatory guidelines (e.g., Quality by Design, FDA)., • Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues, • Conduct rigorous experimental design studies (e.g., factorial design) to achieve project objectives., • Collaborate closely with cross-functional teams, including Technical Services, Operations, and Regulatory Affairs., • Define scope, timeline, and resource needs of functional activities and keep team on schedule, • Participate in evaluation of new product opportunities., • Ensure timely and high-quality documentation for regulatory submissions., • Stay updated with all FDA and regulatory requirements/guidelines., • Provide mentorship and leadership to team members., • Stay up to date with the latest scientific advancements in formulation development and applying new technologies to improve product performance., • Author and review technical reports, protocols, and regulatory documents. Education/Experience: • Ph.D. or Postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field., • 3+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development. (Strong candidates with combinations of education and experience will be considered.), • Strong understanding of formulation principles, excipients, and drug delivery systems., • Hands-on experience with various formulation techniques and equipment., • Proven track record of successful formulation development and commercialization., • Proven track record of successful formulation development for various sterile dosage forms., • Strong leadership, project management, and organizational skills., • Expertise in complex injectable and sterile dosage form development., • Pay range $70,000-$90,000 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 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.

Job 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 Type: Full Time Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA About the Job: Title of the Position: Scientist - Formulation Development We are seeking a highly skilled and experienced Senior Scientist to join our Formulation Development team. The successful candidate will play a critical role in the development and optimization of drug formulations from early-stage research through commercialization. This position requires a deep understanding of formulation principles, a strong scientific background, and a proven track record of success in the pharmaceutical industry. Responsibilities: • Lead the design, development, and optimization of complex injectable and sterile dosage forms., • Develop and implement robust formulation development strategies aligned with regulatory guidelines (e.g., Quality by Design, FDA)., • Conduct rigorous experimental design studies (e.g., factorial design) to achieve project objectives., • Collaborate closely with cross-functional teams, including Technical Services, Operations, and Regulatory Affairs., • Define scope, timeline, and resource needs of functional activities and keep team on schedule, • Ensure timely and high-quality documentation for regulatory submissions., • Stay updated with all FDA and regulatory requirements/guidelines., • Provide mentorship and leadership to team members., • Stay up to date with the latest scientific advancements in formulation development and applying new technologies to improve product performance., • Author and review technical reports, protocols, and regulatory documents. Education/Experience: • Ph.D. or Postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field., • 1+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development. (Strong candidates with combinations of education and experience will be considered.), • Strong understanding of formulation principles, excipients, and drug delivery systems., • Hands-on experience with various formulation techniques and equipment., • Proven track record of successful formulation development and commercialization., • Proven track record of successful formulation development for various sterile dosage forms., • Strong leadership, project management, and organizational skills., • Expertise in complex injectable and sterile dosage form development., • 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 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.

Job 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 Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Quality Assurance QMS Lead-Parenteral (Full Time) At Nivagen as Quality Assurance QMS Lead you will be responsible for supporting the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with regulatory requirements and industry standards. This role involves analyzing quality data, managing documentation, coordinating audits, and driving continuous improvement initiatives to ensure the highest standards of product quality and regulatory compliance within the pharmaceutical industry. Responsibilities: • Responsible for collecting and analyzing information to identify actual and potential product and quality problems, to work with the Site Quality Lead Team to take appropriate and effective corrective and preventive actions, and to verify and validate the effectiveness of CAPA., • Leads, mentors, and coaches' operations and support personnel on the Change control, deviation management system and CAPA program., • To drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence., • Create and maintain the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems., • Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions., • Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed in a timely manner., • Act as a site instructor for Change control, Deviation Management and CAPA courses., • Coaches lead investigators on technical writing., • Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures., • Supports and initiates deviations, trends, or other technical investigations, as applicable., • Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding., • Works with the network deviation program mentor to benchmark and replicate best practices. Education/Experience: • A Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology or Related Sciences from an accredited institution is preferred, • A minimum of Three or More years of experience in in in-process quality assurance or a related role within a pharmaceutical or GMP-regulated environment, or equivalent experience in related fields, is necessary Knowledge, Skills, and Abilities: • Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations, • Proficiency in handling of electronic Quality Management systems (QMS)Experience in conducting root cause investigations, and execution of change management, investigating of deviation/non-conformance., • Ability to communicate effectively with customers to carry out requirements., • Ability to work under time pressure, exert good judgment in special situations, make decisions independently under minimum supervision, and problem solve., • Ability to influence team interactions and lead initiatives., • Demonstrated strong oral and written communication and interpersonal skills., • Demonstrated knowledge and understanding of manufacturing process and Quality Systems., • This involves working in both office and manufacturing environments, requiring adherence to safety protocols and GMP standards, • Occasional travel may be required for audits, supplier evaluations, or training, • Flexibility is required as work hours and starting times may vary to provide coverage on different shifts to meet business needs., • Overtime and weekend work may be required., • Individuals must be available via cell phone (on-call)., • Must live or be willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: • Pay range $75,000-$85,000 per Year / $35/hr. (for hourly basis), • Relocation assistance available, • Annual bonus Eligibility (Based on yearly company and personal performance), • Medical, dental and vision coverage, • Paid time off plan 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.

Job Description POSITION TITLE: Quality Assurance Manager REPORTS TO: Director of Quality DEPARTMENT: Quality Control WAGE CATEGORY: Salary – Exempt LOCATION: Sacramento, CA (Onsite) POSITION OBJECTIVE: Plan, organize, and direct all Quality Assurance activities of Starwest Botanicals, LLC. KEY RESULT AREAS: • Directly manage all aspects of the Quality Assurance function ensuring that all industry GMP’s and the company’s quality assurance objectives are met., • Develop and implement policy and procedures for the efficient operation of the Quality Assurance function., • Develop in conjunction with the Operations and Purchasing Departments strategies to effectively assure the quality and safety of the companies’ products through prerequisite programs, auditing, and process validations., • Develop Quality Assurance operating budgets., • Develop and maintain validated HACCP plan(s) as needed., • Liaison with FDA and 3rd-party food safety inspectors/auditors., • Responsible for regulatory compliance of food safety program., • Develop and maintain an effective supplier auditing program in conjunction with the Purchasing Department., • Hire, train, and evaluate Quality Assurance function personnel., • Support the Sales Departments with product information and specifications., • Evaluate and make recommendations for purchasing food safety, pasteurization, and prerequisite program software and equipment, as needed., • Review and approve Operations SOPs., • Assure that all process errors, product failures and any process deviations are investigated and recommend corrective actions to Production/Maintenance/Engineering., • Assist, as needed, with quality approvals of all finished goods through the quality control laboratory., • Other duties as assigned. POSITION SPECIFICATIONS ESSENTIAL SKILLS AND KNOWLEDGE • Bachelor of Science Degree with emphasis on Food Science and Chemistry., • Minimum 5 years of Quality Assurance Management experience within the Food manufacturing industry., • Strong PC skills to include systems usage, word processing, and spreadsheets., • Excellent oral and written language skills., • Excellent analytical, organizational, and people management skills. DESIRABLE SKILLS AND KNOWLEDGE • Spice and seasoning industry experience, • Botanical products industry experience OTHER FACTORS AND PHYSICAL DEMANDS You must be able to lift, carry, push, and pull 25 lb. rarely. Job requires confined sitting, standing, walking, and finger dexterity sometimes. It requires climbing, crouching, and kneeling rarely. Able to work in variable temperatures, exposure to dust, loud noises and allergens sometimes. Key: Frequently = Often= Sometimes= Rarely= N/A= More than 50% of total work hours Between 20% - 50% of total work hours Between 5% - 20% of total work hours Under 5% of total work hours Not applicable; does not apply to this job Monday - Friday Arrival time between 4am-8am

Job 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 Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Validation Engineer At Nivagen as a Validation Engineer you will be responsible for ensuring that manufacturing processes, equipment, utilities, and systems in the sterile pharmaceutical production environment meet all regulatory requirements, industry standards, and company specifications. The role involves independently working and supporting the validation lifecycle from installation through qualification and routine re-validation activities, ensuring that the company's sterile manufacturing processes are in compliance with cGMP (current Good Manufacturing Practices) and other regulatory guidelines such as FDA, EMA, and ISO standards. Responsibilities: • Qualification of Equipment and Systems:, • Perform or oversee the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of new and existing equipment and systems., • Qualification of equipment in sterile manufacturing facility (e.g., aseptic processing, sterile filling, isolators, autoclave sterilization)., • Ensure compliance with regulatory requirements for equipment qualification and validation., • Knowledge of validation equipment like Kaye validator, temperature and RH data loggers etc., • Validation Documentation and Protocols:, • Prepare and review validation reports to ensure they meet regulatory and company requirements., • Maintain traceability of validation activities and ensure all validation records are accurately documented, maintained, and stored., • Process Validation and Cleaning Validation:, • Conduct and manage process validation studies to confirm the sterility and quality of pharmaceutical products., • Work with cross-functional teams (e.g., production, quality control, engineering) to optimize manufacturing processes and ensure consistency and repeatability., • Support the development and implementation of new processes, ensuring that they are validated per regulatory requirements., • Knowledge of cleaning validation will be an added advantage Education/Experience: • Bachelor's degree or Diploma in Pharmaceuticals, or a related field., • Minimum 2 years of experience in a pharmaceutical manufacturing or validation role, with a focus on sterile manufacturing (e.g., aseptic processing, sterile filling, isolator, autoclave sterilization)., • Strong understanding of cGMP, FDA, EMA, ISO standards, and other relevant regulatory requirements., • Experience with equipment validation (e.g., filling machines, autoclaves, and HVAC systems) and process validation., • Excellent technical writing and documentation skills., • Strong attention to detail and ability to manage complex technical documentation., • Ability to work cross-functionally and manage multiple priorities., • Familiarity with data analysis tools and software used for validation testing and reporting (e.g., Excel, Validation Master Plans, LIMS systems)., • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius), • Cleanroom and sterile production areas with controlled environments., • Competitive salary, • 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 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.

Job 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 Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Quality Assurance Manager-Parenteral (Full Time) At Nivagen as Quality Assurance manager you will be responsible for overseeing and managing all QA activities related to the manufacturing of sterile injectable (parenteral) products. This includes ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements (e.g., FDA, EMA, MHRA). The QA Manager will lead a team in managing quality systems such as deviations, CAPAs, change control, batch release, validation oversight, and audit readiness. The role requires close collaboration with production, QC, regulatory affairs, and engineering teams to ensure consistent product quality and continuous improvement. Responsibilities: • Perform on-the-floor QA tasks within the manufacturing areas as needed, collaborating with manufacturing and other departments to provide routine quality support, and maintain inspection readiness., • Provide triage support across departments to address moderate quality issues, ensuring timely escalation to management when necessary., • Review and approve deviations, including the associated investigation reports, and corrective/preventative actions., • Review and approve change controls for appropriateness, completeness and alignment with quality, validation, and regulatory expectations., • Review and approve sampling protocols, risk assessments, and master batch records., • Author, review and approve SOPs as appropriate for both Operations and Quality., • Assist with additional tasks, including (but not limited to) Master Data management / approval, GMP area walkthroughs, product changeover activities., • Participate in internal audits, support regulatory inspections or customer audit activities, as needed., • Maintain and update quality-related documents, records, and reports within the quality management system (QMS), ensuring accuracy, consistency, and regulatory compliance., • Assist in the development or assignment of training to key stakeholders related to QMS., • Contribute to the preparation of Periodic Quality Reviews., • Assume responsibility for any additional quality-related activities delegated to the hub, ensuring effective management in alignment with Quality standards. Education/Experience: • Candidates with a Bachelor's degree must have at least 10 years of relevant experience; those with a Master's degree require 5+ years of experience., • Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations, • Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards., • Proactive approach and strong critical thinking skills., • Must be able to work in a team environment within own team and interdepartmental teams., • Excellent communication and interpersonal skills., • Experience in quality administered systems., • Strong organizational skills and attention to detail., • Experience with regulatory compliance and documentation., • Ability to mentor and review the work of other colleagues., • This role is primarily day shift, Monday – Friday, with 24/7 support of manufacturing as quality issues arise., • Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements., • Collaboration skills and the ability to independently engage with a wide range of colleagues, and management to gather the input and background knowledge needed to complete assignments., • Must be able to gown for entering controlled areas., • Must be able to wear specialized protective clothing, wear PPE (safety shoes/glasses/etc.)., • Flexibility is required as work hours and starting times may vary to provide coverage on different shifts to meet business needs., • Overtime and weekend work may be required., • Individuals must be available via cell phone (on-call)., • Pay range $85,000-$95,000 per Year / $40/hr. (for hourly basis), • Relocation assistance available, • Annual bonus Eligibility (Based on yearly company and personal performance), • Medical, dental and vision coverage, • Paid time off plan 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.

Job 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 Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834. About the Job: Title of the Position: Visual Inspection and Packing Operator At Nivagen, the Visual Inspection and Packaging Operator plays a critical role in ensuring product quality and compliance. This position is responsible for conducting manual visual inspections to verify that products meet established quality standards. Additionally, the operator will oversee the operation of leak testing machines and packaging equipment to ensure products are properly prepared for shipment. All tasks must be performed in strict adherence to company protocols and regulatory requirements, maintaining the highest standards of product quality and safety throughout the production process. Responsibilities: • To perform the visual inspection of the filled containers i.e., vials (liquid and lyophilized), pre-filled syringes, cartridges and IV bags., • To identify the defects i.e., fill volume inconsistencies, glass pieces, metal, colored particles, fibers, cap defects, sealing defects, label flaws, printed text matter flaws, batch coding flaws, wrong labelling, cross labelling flaws etc. and shall ensure no defective product shall be supplied to the market., • Segregation of the defects and preparation of defective library and preparation of Knapp kits required for the qualification of automatic inspection machines., • Preparation of the documents (including SOPs, batch records), protocols required for operation and maintenance of the VI, leak testing and packing equipment., • Responsible for collection, transportation, and storage of the semi-finished products as per product storage conditions., • Shall take utmost care to avoid the cross-contamination and mix-up errors., • Shall be responsible for the storage of the semi-finished and finished products, • Collaborate effectively with cross-functional departments to ensure timely coordination and organization of all prerequisites, supporting the smooth operation of the department and ensuring the delivery of finished products that meet market needs and business demands., • Qualification/validation of the equipment and area in accordance with approved protocols and preparation and readiness for the routine commercial manufacturing., • To perform in process, check and controls in accordance with approved protocols, batch records, SOPs and regulatory guidelines., • Collaborate closely with production staff, including operators, supervisors, and quality control teams, to ensure product quality and timely delivery, while actively participating in team meetings and training sessions as required., • Prepare products for secondary packing using the correct materials and pack them according to company specifications. Ensure packaging is sealed, labelled correctly, and checked for completeness and accuracy., • Collaboration with warehouse, production, in-process quality teams for timely support and product deliverables to meet OTIF., • Adhere to safety guidelines, promptly report hazards or accidents, and ensure the work area remains clean and organized., • Involved in daily operations, including cleaning, maintaining logs, and overseeing routine packing activities to ensure efficiency and compliance, • Tracking defect trends, maintaining control over defect storage, conducting periodic reviews, and implementing control and mitigation plans, • Managing market complaints, conducting investigations, implementing corrective actions, and preventing future occurrences., • Inventory management for the consumables required for the day-to-day packing activities., • cGMP, FDA regulations, and SOPs related to sterile and non-sterile pharmaceutical production., • Strong attention to detail and ability to detect visual defects., • Proficiency in operating inspection and packaging equipment., • Ability to follow written instructions and complete documentation accurately., • Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents), • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius), • Able to successfully complete a drug and background check, • stand, walk, and perform tasks for extended periods, lift and move products up to 35 kg, and demonstrate good hand-eye coordination and fine motor skills for inspection and packing duties., • Must comply with cleanroom protocols, gowning, and PPE requirements., • Pay range $20.0 - $25.0 per hour (Based on Experience), • 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 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.

Job DescriptionSalary: $100K-$115K Maintenance Reliability Manager Job Description Nichirei is a growing innovative company that is part of Japan's #1 Frozen Food manufacturer. We produce savory and convenient frozen food products in West Sacramento. We are looking for a Maintenance Reliability Manager with 7 years of experience with maintenance. Food manufacturing is preferred and a plus. • Develop and manage a program to identify asset reliability risks and manage asset failure prevention., • Develop and implement data driven maintenance strategies to support strategic direction of the company., • Plan and oversee all repair, servicing and installation activities., • Develop a comprehensive and effective Preventative Maintenance program., • Develop Maintenance procedures and ensure implementation., • Ensure critical spare parts are kept in inventory and establish minimum levels and reorder quantities., • Allocate workload and supervise team members., • Be a coach and mentor to the Maintenance team and identify training needs., • Provide direction in technical matters and serve as a subject matter expert in mechanical, electrical and control equipment., • Ensure all work activities are completed correctly according to Food Safety and OSHA safety rules., • Ensure complete maintenance records are kept., • Identify areas of improvement for safety, productivity and work practices., • Manage relationships with contractors and service providers., • Ensure workplace Health & Safety policies are complied with in full., • Oversee activities of the Maintenance Coordinator to ensure accurate inventory., • Be proactive in identifying suppliers for parts and services. Ensure the vendors are most competitive in price whilst maintaining quality of workmanship and service., • Manage the Maintenance Department budget and alert management of exceptional expenditures., • Proactively identify opportunities to improve efficiency, reduce costs and improve safety., • Contribute expertise to Capital Expenditure decisions and implementation of Capital projects., • Ensure compliance with Local, State and Federal requirements i.e. permits, licenses etc., • Ensure the Maintenance department is organized and there is a culture of good housekeeping. Skills: • Previous track record as a Maintenance & Facilities Manager in a food manufacturing facility, • Experience in planning maintenance activities, • Strong project management skills, • Solid understanding of equipment and processes e.g. Boilers, refrigeration, compressed air, packaging equipment, natural gas systems., • Solid understanding of facilities Maintenance., • Familiarity with automation and PLC technology, • Ability to communicate with colleagues and vendors/contractors both verbally and in writing., • Organized and detail orientated., • Ability to prioritize and complete multiple tasks., • Ability to identify alternative solutions when faced with unforeseen situations., • Good knowledge of Microsoft Office programs and CAD., • Experience in Lean Manufacturing Principles. Experience: • Technical/Engineering degree, • Minimum 7 years relevant experience in reliability and maintenance management, • Food manufacturing experience frozen food production a plus, • Previous experience with implementation of a CMMS system., • Knowledge of regulatory standards including USDA, FDA, OSHA & HACCP, • Valid Drivers License Job Type:Full-time Salary: $100,000.00 - $115,000.00 per year Benefits: • Health Insurance & Dental insurance, • Life insurance, • Simple IRA Plan Experience level:7 years. Schedule: 8-hour shift, Monday to Friday. Flexibility for off-shift and weekend work is expected as required. Work setting: In-person, Office. Ability to commute/relocate: West Sacramento, CA 95691: Reliably commute or planning to relocate before starting work (Required)