Pharmaceutical compliance jobs in Sacramento, CaliforniaCrear alertas

Job Description Job Summary Working and training as an RLS Pharmacy Technician is a great way to learn an exciting new skill set within the field of pharmacy away from more traditional pharmacy challenges such as drive-throughs and insurance problems. As an RLS Pharmacy Technician, you will gain experience in areas such as aseptic processes, radiopharmaceuticals, general regulatory compliance and quality assurance. The Pharmacy Technician supports pharmacy operations by processing prepared products and handling, packaging and delivering radiopharmaceuticals. Key Accountabilities • Compound and dispense radiopharmaceuticals under the supervision of a Pharmacist, • Package radiopharmaceuticals for delivery for customers, • Perform quality control on compounded products, • Manage and maintain facility inventory, • Perform disinfection task in the cleanroom, and stocking of sterile supplies, • Maintain documentation for regulatory programs utilizing good documentation practices (gdp), • Process and/or dual verify prescription entries, • Perform leukocyte labeling procedures, • Eligible to work in the United States., • High School Diploma or GED/local equivalent, • Ability to accommodate shift changes based on business needs, • PTCB certified or successful completion within 6 months of hire or current enrollment in an Accredited School of Pharmacy, • Applicable Pharmacy Technician State License, • Must be able to lift 50 pounds, • Proof of vaccination for Covid 19 to meet compliance obligations for Customer mandated on-site requirements, • Previous experience handling radiopharmaceuticals., • Previous experience processing prescriptions and/or preparing pharmaceutical, • Previous experience in sterile compounding., • Ability to communicate effectively and in a professional manner, • Ability to prioritize job duties., • Accept and adhere to high ethical values in decisions and actions

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 for performing manual visual inspection of products to ensure that defined quality standards are met. The role also involves operating manual and/or automatic leak testing machines and packing equipment to prepare products for shipment. The operator must perform activities related to sterile manufacturing, as and when required, and ensure that all operations are carried out in strict compliance with company policies, standard operating procedures, applicable regulatory requirements, and current Good Manufacturing Practices (cGMP), while upholding the highest standards of product quality and safety throughout the production process. Responsibilities: • To perform the visual inspection of the filled containers manually i.e., vials (liquid and lyophilised), pre-filled syringes, cartridges and IV bags., • To identify the defects i.e., Volume variation, particulate matter (such as glass pieces, any type of particles, fibres, etc.) Cosmetic defects (such as cap defects, sealing defects, label flaws, printed text matter flaws, external contamination, damage, wrong labelling, cross labelling flaws etc.) and shall ensure no defective product shall be supplied to the market., • Reconciliation and Segregation of the good and defective containers, preparation of defect library and preparation of Knapp/qualification kits required for the qualification of automatic inspection machines., • Assist and prepare documents (includes SOPs, batch records), protocols required for operation and maintenance of the VI, leak testing and packing equipment., • Responsible for handling, collection, transportation,and storage of the semi-finished and finished products as per product storage conditions and as per process requirements., • Responsible for avoiding cross-contamination and mix-up errors at various stages of operations., • Responsible for collaborating 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., • The role requires the ability to 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., • The role requires good eyesight, strong attention to detail, the ability to identify defects or discrepancies, and a basic understanding of visual inspection and packaging requirements., • To perform in process, check and record details in documents in accordance with approved protocols, batch records, SOPs and regulatory guidelines., • Collaborate closely with production staff, including operators, supervisors, and cross-functional teams, to ensure product quality and timely delivery, while actively participating in team meetings and training sessions as required., • Packaging of products with secondary packing materials and packing them according to company specifications. Ensure packaging is sealed, labelled correctly, and checked for completeness and accuracy., • Perform various packaging operations such as labelling of carton/pouch, carton/pouch packaging, weighing of carton /pouch, printing and verification of batch details on carton/pouch, tertiary packaging as per packaging configuration and standards., • 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 visual /packing activities to ensure efficiency and compliance, • Tracking defect trends, maintaining control over defect storage, conducting periodic reviews, and implementing control and mitigation plans, • Assist and 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., • Handling of Autoclave, Isolator and Filling machine as and when required., • Must be aware of clean room gowning., • 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 be willing to move to the 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 $18 - $25 per hour (Based on Experience), • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, including 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 Contract Attorney or Paralegal - 340B Program (Remote) Remote (Any State License Accepted) Employment Type: Contract (Set your own hours for a project) About the Role: We are seeking a highly skilled and detail-oriented Contract Attorney or Paralegal with expertise in the 340B Drug Pricing Program to join our team on a remote, contract basis. This role will provide critical legal and regulatory support to ensure compliance with 340B program requirements, assist with audits, and help navigate complex legal issues related to pharmaceutical pricing and healthcare regulations. The ideal candidate will have a strong background in healthcare law, contract review, and regulatory compliance, with specific experience in the 340B program. Key Responsibilities: • Provide legal analysis and guidance on 340B program compliance, including eligibility, contract pharmacy arrangements, and regulatory changes., • Review, draft, and negotiate contracts related to the 340B program, including agreements with covered entities, contract pharmacies, and third-party administrators., • Assist with internal and external audits, including preparing documentation, responding to inquiries, and ensuring compliance with 340B program requirements., • Monitor and interpret federal and state regulations, guidance, and policies related to the 340B program and healthcare compliance., • Collaborate with internal stakeholders, including legal, compliance, and pharmacy operations teams, to address legal and regulatory risks., • Conduct legal research and prepare memoranda on issues related to the 340B program, healthcare law, and pharmaceutical pricing., • Support dispute resolution efforts, including responding to HRSA (Health Resources and Services Administration) inquiries or allegations of non-compliance., • Stay up-to-date on industry trends, litigation, and enforcement actions related to the 340B program. Qualifications: • For Attorneys: Juris Doctor (JD) degree from an accredited law school and active bar membership in good standing in any U.S. state., • For Paralegals: Paralegal certification or equivalent experience, with a strong background in healthcare law or regulatory compliance., • Minimum of 3-5 years of experience working with the 340B Drug Pricing Program, healthcare compliance, or pharmaceutical law., • In-depth knowledge of 340B program regulations, HRSA guidelines, and related federal and state laws., • Experience drafting, reviewing, and negotiating contracts, particularly in the healthcare or pharmaceutical industries., • Strong analytical skills with the ability to interpret complex regulations and provide actionable recommendations., • Excellent written and verbal communication skills, with the ability to communicate legal concepts to non-legal stakeholders., • Self-motivated and able to work independently in a remote environment., • Proficiency with Microsoft Office Suite and legal research tools (e.g., Westlaw, LexisNexis). Preferred Qualifications: • Experience working with covered entities (e.g., hospitals, clinics, federally qualified health centers) or contract pharmacies., • Familiarity with Medicaid drug rebate programs and other pharmaceutical pricing regulations., • Prior experience supporting 340B program audits or dispute resolution processes. Why Join Us? • Fully remote position with flexible hours., • Opportunity to work on impactful projects within the healthcare and pharmaceutical industries., • Collaborative and supportive team environment.

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: Compounding Pharmacist (Full Time) The Compounding Pharmacist at Nivagen will be responsible for leading the 503B outsourcing facility, ensuring adherence to compounding standards and regulatory compliance. This role is pivotal in meeting manufacturing and company goals by overseeing the successful operations of a fully compliant department. Key responsibilities include maintaining facility and equipment standards, ensuring safety, upholding product quality, optimizing manufacturing efficiency, and managing quality systems in line with regulatory requirements. The Compounding Pharmacist will report directly to the CEO and/or the Production Manager. Responsibilities: • Work with Production Lead to achieve daily compounding output goals, • Design weekly production schedule with Production Lead, • Assign technician roles for the week (i.e. Mixer, Filler, Assistant, etc.), • Direct techs to a particular task to maintain production flow, • Complete Batch records, • Supervise compounding activities, • Perform Mixer, Filler, Assistant, or any technician duties as needed, • Check customer orders for accuracy, • Clinical customer service (Drug info, IV compatibility, osmolarity calculations etc.), • Controlled substance records management, • QA reports/investigations as assigned: MOCA, CAPA, MRDD, Complaints, • Maintain team's cGMP compliance at MSRX, • Participate in regulatory audits, • Draft SOPS revisions, process validation, draft a master compounding record, Process Validation etc Education/Experience: • Doctor of Pharmacy (Pharm.D.) degree from an accredited institution, • Understanding and experience in USP 797 guidelines and manual aseptic manipulations, • Strong leadership skills with the ability to manage and mentor a team, • Excellent communication and organizational skills, • Experience with regulatory audits and inspections is a plus., • California Pharmacist License in good standing, • Knowledge and experience in cGMP and FDA 21 CFR parts 210 and 211, • Experience participating in a Manufacturing Unit in an FDA registered facility that includes cGMP compliance and sterile product preparation of pharmaceuticals OR experience as a pharmacist in a pharmacy that prepares sterile parenteral compounds, • Work in controlled environments and wear personal protective equipment as necessary, • Board certified Sterile Compounding pharmacist certification preferred., • Knowledge within the areas of quality control and process validation, • Familiarity and understanding of manufacturing methods related to quality control and quality assurance, • Experience participating in a supply chain management in an FDA approved GMP facility that includes cGMP compliance and sterile product preparation for pharmaceuticals, • Pay range $160,000-$180,000 per year, • Performance-Based Incentive, • Benefits: Medical, Dental and Vision coverage, • Paid time off plan, • This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required, • This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR), • Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve-hour shift. Must be able to lift up to 50lbs 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.

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Sr. Specialist, Quality Assurance is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The Sr. Specialist will support complex problem-solving initiatives and help drive continuous improvement at the site. This position is expected to coach / develop site personnel and improve overall execution within the quality systems. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), validation, and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.Physical Demands • Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment., • Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.Work Conditions, • Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs., • Must be comfortable regularly participating in video-based meetings., • May be required to work scheduled overtime, weekends, or holidays based on business needs.Essential Duties & Key Responsibilities:, • Quality System Management:, • Oversee the management of quality systems including deviations, change controls, CAPAs, validation, and document control., • Provide clear direction, support, and/or coaching to site personnel, improving the overall performance and/or execution in the quality systems., • Directly support the Process Validation program, including the Continuous Process Verification (CPV) program. Directly support investigations of any identified trend., • Ensure that all deviations are investigated thoroughly and timely, identifying root causes and implementing effective corrective actions., • Review and approve change controls to ensure compliance with regulatory requirements and internal procedures., • Maintain and improve CAPA processes to ensure effective resolution of quality issues., • Batch Disposition:, • Evaluate batch records and associated documentation to make informed batch release decisions., • Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release., • Monitor and document any quality issues related to batch production and implement corrective measures as necessary., • Document Management:, • Maintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards., • Conduct regular reviews of quality documentation to ensure adherence to established protocols and procedures., • Regulatory Compliance:, • Stay informed of current regulations, industry trends, and best practices in pharmaceutical quality assurance., • Assist in preparing for internal and external audits, ensuring that all quality systems and documentation are audit-ready., • Training and Support:, • Develop / coach site personnel to improve overall performance in quality systems., • Provide training and guidance to staff on quality systems, processes, and compliance requirements., • Serve as a point of contact for quality-related inquiries and issues, fostering a culture of quality within the organization., • Continuous Improvement:, • Lead continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes., • Identify areas for improvement within quality operations and drive appropriate solutions to closure., • Track completion of quality records and maintain metrics., • Perform other duties as requested by supervisor/manager to support Quality, • Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.Minimum Qualifications:, • Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 6+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 4+ years of experience, • Minimum 6+ years of relevant Quality Assurance or Quality Systems experience in a GxP-regulated environment, with at least 2 years in a leadership role., • Understanding of FDA regulations, GMP compliance, and quality system processes, • Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred, • Able to meet project and testing timelines, • Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management, • Able to work collaboratively to respond to changing priorities and challenges, • Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment, • Prior experience doing internal audits and document control management, • Communicate effectively with team members and contribute to a positive and collaborative work environment, • Actively participate in group and project teamwork; project and process improvements, • Strong organizational skills and the ability to manage multiple tasks concurrently, • Willingness to learn and adapt in a fast-paced, dynamic environment, • Adhere to cGMP policies and procedures, including documentation activities, • Able to wear appropriate personal protective equipment

Job DescriptionCapital Project Manager IV Primary Duties: Manages assigned capital facility design, construction, or maintenance projects within a pharmaceutical manufacturing environment. Responsible for coordinating internal resources and external contractors to ensure assigned capital improvement projects are delivered safely, on time, within budget, and in alignment with applicable regulatory, quality, and safety requirements. Projects are typically moderate in complexity and executed within established standards, procedures, and governance frameworks. Responsibilities: • Coordinate work activities of internal engineering, design, maintenance staff, and external contractors or subcontractors to support the successful execution of assigned capital projects., • Independently manages day-to-day project execution, ensuring scope, schedule, budget, and quality expectations are met., • Track project progress against defined milestones, budgetary guidelines, and other performance indicators., • Prepare and deliver clear, accurate project status updates and reports to management., • Develops and maintains project schedules, cost estimates, forecasts, and documentation in accordance with standard project management practices., • Select, negotiate with, and manage activities of external consultants, vendors, and service providers in accordance with company procurement and contracting guidelines., • Supports vendor and contractor selection processes and monitors performance in accordance with company procurement and contracting guidelines., • Identify routine project risks, issues, and deviations; implement mitigation actions within established authority and escalate higher-risk or non-standard issues as appropriate., • Support compliance with applicable GMP, safety, and site standards during design, construction, and turnover activities., • Participate in project closeout activities, including documentation handoff and lessons learned., • Supports financial reconciliation and turnover documentation as part of project closeout., • May provide informal guidance or knowledge-sharing support to junior team members., • Bachelor’s degree in Engineering, Construction Management, Facilities Management, or a related technical discipline., • 7 years of experience managing facility, construction, maintenance, or capital projects in an industrial, manufacturing, or regulated environment., • Project management and project scheduling skills, • Strong oral and written communication skills, • Ability to work effectively as part of a cross-functional team, • Ability to build collaborative working relationships, • Analytical and research skills to identify and seek needed information, • Strong organizational and follow-through capabilities., • This role may involve work in laboratory or manufacturing environments with potential exposure to chemicals or other regulated substances. As a condition of employment, incumbents may be required to participate in employer-provided medical surveillance programs in accordance with applicable regulatory requirements and company policy. Estimated Min Rate: $52.50 Estimated Max Rate: $75.00 What’s In It for You? We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include: • Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week), • Health Savings Account (HSA) (for employees working 20+ hours per week), • Life & Disability Insurance (for employees working 20+ hours per week), • MetLife Voluntary Benefits, • Employee Assistance Program (EAP), • 401K Retirement Savings Plan, • Direct Deposit & weekly epayroll, • Referral Bonus Programs Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: Company DescriptionFounded in 1940, Yoh operates from 75 locations throughout North America and is headquartered in Philadelphia, PA. Yoh was the nation’s first technology staffing firm. As a business unit of Day & Zimmermann, Yoh has a flourishing global footprint, as our parent company operates from more than 150 worldwide locations. Company Website: in 1940, Yoh operates from 75 locations throughout North America and is headquartered in Philadelphia, PA. Yoh was the nation’s first technology staffing firm. As a business unit of Day & Zimmermann, Yoh has a flourishing global footprint, as our parent company operates from more than 150 worldwide locations.\r\nCompany Website:

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: Director of Validation The Director of Validation is responsible for the strategic leadership, execution, and continuous improvement of all validation activities at a sterile pharmaceutical manufacturing site. This role ensures that facilities, utilities, equipment, processes, cleaning, computerized systems, and aseptic operations are validated and maintained in a state of control in compliance with global regulatory requirements (FDA, EMA, ICH, and other applcable authorities). The Director of Validation partners cross-functionally with Quality, Engineering, Manufacturing, Automation, IT, and Regulatory Affairs to support commercial manufacturing, new product introductions, site expansions, and regulatory inspections. Responsibilities: Validation Leadership & Strategy • Develop and execute the site validation master plan (VMP) for sterile manufacturing operations, • Establish a validation strategy aligned with lifecycle validation principles and regulatory expectations, • Lead validation activities for new facilities, expansions, equipment, and technology transfers, • Oversee validation of:, • Aseptic processing and fill/finish operations, • Cleanrooms and controlled environments, • Utilities (WFI, clean steam, compressed gases, HVAC), • Equipment (formulation vessels, autoclaves, washers, filling lines, Isolators, and RABs), • Process validation (PQ, PPQ, CPV), • Cleaning validation, • Computerized systems validation (CSV / CSA), • Ensure validation documentation meets GMP, data integrity, and inspection readiness standards, • Serve as validation SME during regulatory inspections and customer audits, • Address validation-related observations, CAPAs, and commitments, • Lead, mentor, and develop a team of validation engineers and managers, • Set clear performance goals and promote a culture of quality, accountability, and collaboration, • Partner with Engineering on equipment qualification and commissioning strategies, • Collaborate with Quality Assurance on change control, deviations, and risk management, • Support Manufacturing and Technical Operations with troubleshooting and process improvements, • Drive improvements in validation efficiency through risk-based approaches and digital tools, • Implement best practices for commissioning and qualification (C&Q) and CPV Education • Bachelor's degree in engineering, Life Sciences, or related discipline (required), • 10+ years of experience in validation within GMP pharmaceutical manufacturing, • Minimum 5 years of leadership experience in sterile or aseptic manufacturing environments, • Proven experience supporting regulatory inspections (FDA, EMA), • Deep knowledge of sterile manufacturing validation and aseptic processing, • Strong understanding of FDA, EMA, ICH, and Annex 1 requirements, • Expertise in lifecycle validation, CPV, and risk-based validation approaches, • Strong people leadership and organizational skills, • Excellent communication and stakeholder management abilities, • Ability to influence across functions and at senior leadership levels, • 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 be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius), • On-site presence required to support sterile manufacturing operations, • 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 devoted to improving lives by developing high-quality, affordable generic prescription drugs and over-the-counter products for the North American market. For over a decade, we have remained committed to our core values of excellence, integrity, and respect for people. Our dedicated team works collaboratively to advance manufacturing, distribution, and quality control, taking a comprehensive approach to healthcare. Through vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and an unwavering focus on excellence, we continually strive to enhance medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and strong training and development programs. By investing in our workforce and nurturing a culture of growth and support, we empower our team to drive innovation and make a positive impact in healthcare. Our mission at Nivagen is clear: to improve lives by providing high-quality, affordable medications while upholding the highest standards of integrity and excellence. As a leader in pharmaceutical manufacturing, Nivagen is committed to producing sterile products that meet the healthcare industry's rigorous demands. Specializing in the production of vials, pre-filled syringes (PFS), and IV bags, we aim to make a meaningful impact on patient care. Join our team to help push the boundaries of sterile manufacturing, achieving the highest standards in safety, quality, and operational efficiency. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Director of Quality Control Department: Quality Control Reports to: Head of Quality The Director of Quality Control leads all QC operations within a pharmaceutical manufacturing facility, ensuring reliable, compliant testing that meets regulatory expectations and supports timely product release. This role oversees QC laboratories (chemistry, microbiology, analytical development support, raw materials, stability, and in-process testing), manages scientific and operational strategy, drives continuous improvement, and ensures data integrity and regulatory compliance across all laboratory activities. Responsibilities: * Leadership & Management • Provide strategic leadership for QC teams, including chemistry, microbiology, stability, and raw materials testing., • Develop and mentor QC managers, supervisors, and analysts to ensure strong technical capability and compliance culture., • Establish resource plans, staffing, skills development, and succession planning., • Direct day-to-day QC operations to support manufacturing schedules, ensuring on-time testing and release., • Oversee testing for raw materials, in-process samples, finished products, environmental monitoring, and stability programs., • Ensure proper functioning, maintenance, and qualification/calibration of all lab equipment., • Oversee sample management, laboratory workflows, and prioritization., • Ensure all QC activities comply with cGMP, FDA/EMA/ICH guidelines, USP/EP/JV standards, and company SOPs., • Own and maintain quality systems related to laboratory operations, including:, • Change control, • Deviations and investigations, • CAPA management, • Document control, • Data integrity program, • Prepare for and lead QC aspects of regulatory inspections and internal/external audits., • Oversee method validation, verification, transfer, and lifecycle management activities., • Evaluate and implement new analytical technologies to improve QC reliability, efficiency, and scientific rigor., • Collaborate with R&D/Analytical Development to ensure smooth tech transfer of analytical methods and specifications., • Oversee design, execution, and monitoring of stability studies in compliance with ICH guidelines., • Develop, track, and report quality metrics (e.g., OOS rate, lab investigation cycle time, test turnaround time, EM trends)., • Drive continuous improvement initiatives such as Lean lab practices, automation, and digitalization., • Act as a QC subject matter expert in cross-functional teams, including QA, Manufacturing, Regulatory Affairs, Supply Chain, and R&D., • Participate in material/vendor qualification, change control reviews, and deviation boards. Education/Experience: • Master's or PhD in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related discipline preferred., • A bachelor's degree with extensive experience may be considered., • 10+ years of experience in QC within pharmaceutical or biopharmaceutical manufacturing., • 5+ years of leadership/management experience in a GMP laboratory setting., • Experience preparing for and hosting inspections by FDA, EMA, or other health authorities., • Strong background in analytical chemistry and/or microbiology., • Experience with method validation, QC automation, LIMS/ELN, and electronic data management systems. Knowledge, Skills, and Abilities: • Deep knowledge of cGMP, ICH guidelines, USP/EP, and regulatory expectations., • Strong scientific judgment and technical problem-solving skills., • Excellent leadership, communication, and interpersonal skills., • Ability to manage multiple priorities and drive timely execution., • Pay range: Competitive Salary Range 120k - 140k Annually, • 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. 3900 Duckhorn Drive, Sacramento, CA 95834 About the Job: Title of the Position: QA Specialist As a Quality Assurance (QA) Specialist, you will play a critical role in ensuring that all products, processes, and documentation meet established quality standards, regulatory requirements, and company policies. Your responsibilities will include maintaining compliance with cGMP, GLP, and other industry regulations, safeguarding product integrity, and supporting continuous improvement initiatives. You will manage Quality Management Systems (QMS), review critical documentation, oversee training programs, and ensure adherence to organizational quality objectives. Responsibilities: • Responsible for collecting and analysing 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., • Effective implementation of electronic Quality Management system (eQMS) across organizations. Education/Experience: • Bachelor's degree in a relevant field such as Pharmacy, Chemistry, Microbiology, Biotechnology, or a related discipline., • Strong knowledge of cGMP, GLP, and quality standards such as ISO 9001., • Proficiency in managing Quality Management Systems (QMS)., • Familiarity with laboratory instruments and analytical methods., • Experience with document control processes and regulatory audits., • Excellent attention to detail and strong organizational skills., • Effective communication and interpersonal skills for collaboration across departments., • Strong analytical and problem-solving abilities., • Ability to work independently and as part of a team in a fast-paced environment., • Legally authorized to be employed in the United States, • Pay range $25.0 per hour to annual salary of $70,000, • 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 DescriptionCompany Description Eurofins Scientific is a network of independent companies providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. With over 50 laboratories and more than 40 service centers nationwide, Eurofins Environment Testing provides full-service environmental analysis across all 50 states. Our network supports public and private clients—including DoD, DOE, and municipalities—through robust logistics and continuous investment in people, technology, and infrastructure. We offer comprehensive testing for air, water, soil, sediment, tissue, and waste, covering a wide range of analytes including PFAS, metals, VOCs/SVOCs, dioxins/furans, radiochemicals, and more. Job Description Eurofins Environment Testing Northern California is seeking a Laboratory Technician I for our West Sacramento location. The Laboratory Technician, using general laboratory methods, techniques, equipment, and instrumentation in compliance with Eurofins’ Quality Assurance programs and SOP’s, supports laboratory operations through general maintenance of laboratory and supply storage areas, equipment, instruments, and supplies. Essential Duties and Responsibilities Retrieves samples from Sample Control for analysis and maintains chain of custody. Performs sample preparation which may include, but is not limited to, a combination of the following methods: • Aliquot samples, • Spike and trace samples, • Prepare reagents/acids/bases, • Bottle samples, • Prepare concentrations, • Separation, • Sonication Prepares general laboratory paperwork such as recording analysis results, tracking samples, bench sheets, and laboratory logbooks. Washes laboratory glassware to prepare for next day’s samples. Responsible for performing job functions within Eurofins Environment Testing America’s Environmental Health & Safety and Quality Assurance standards. Maintains housekeeping for work area. Preforms daily calibration of pipettes and balances. Properly disposes of hazardous and non-hazardous waste and recycling. Secondary Duties Stocks laboratory supplies. Cleans work area(s) to maintain a safe working environment. Assists other laboratory areas as needed Qualifications • High school diploma or equivalent, • High school Chemistry coursework, basic laboratory experience, • Experience working in a fast-paced, production environment, • Authorization to work in the United States indefinitely without restriction or sponsorship, • Professional working proficiency in English is a requirement, including the ability to read, write and speak in English Additional Information Compensation range: $19-$21 per hour depending on experience and qualifications. Position is full-time, non-exempt and is eligible for overtime pay. Candidates must be able to work the following shifts: • Sunday - Thursday, 7PM - 3:30AM with possible overtime and weekends as needed. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options. We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: Company description: Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Job DescriptionCompany Description Eurofins Scientific is a network of independent companies providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. With over 50 laboratories and more than 40 service centers nationwide, Eurofins Environment Testing provides full-service environmental analysis across all 50 states. Our network supports public and private clients—including DoD, DOE, and municipalities—through robust logistics and continuous investment in people, technology, and infrastructure. We offer comprehensive testing for air, water, soil, sediment, tissue, and waste, covering a wide range of analytes including PFAS, metals, VOCs/SVOCs, dioxins/furans, radiochemicals, and more. Job Description Eurofins Environment Testing is seeking a Senior Analyst to join our team! The Senior Analyst will have previous experience with HR/MS instrumentation in a production, laboratory setting. The Senior Analyst prepares and analyzes environmental samples using standard analytical techniques according to scientific and EPA methodology in compliance with Eurofins' Quality Assurance programs and SOP’s. The Senior Analyst is responsible for maintaining instrumentation; tuning and calibrating instrument daily; analyzing quality control and client samples; reviewing and assembling data in an efficient manner with a high degree of quality; evaluating current organizational and analytical systems; diagnosing complex problems and offering solutions with a high degree of independence; suggesting and implementing improvements to maximize quality and productivity; acting as technical resource for internal problems and projects; assisting in “brainstorming” client problems and projects; training new employees in all aspects of instrumentation; researching new and emerging technologies. Essential Duties and Responsibilities: • Applies GMP/GLP in all areas of responsibility, as appropriate, • Demonstrates and promotes the company vision, • Regular attendance and punctuality, • Perform routine and advanced maintenance on the instrumentation, • Tune and calibrate instrumentation, • Analyze samples and associated QC, • Review, work up, and assemble all supporting data, • Read, understand, and carry out SOPs required by EPA or company methods, governing agencies, clients, and our internal QC department, • Perform additional responsibilities (i.e., audit, verification, etc.) with minimal supervision, • Evaluate current analytical system performance and recommend corrective action to enhance efficiency and productivity, • Train other departmental analysts in procedures related to operations listed in the above, • Search technical literature for scientific information relative to improving analytical or operational performance, • Understand and use LIMS, • Make working calibration standards, • Use word processor on PC, • Monitor and change gas cylinders, • Review and amend departmental methods when required, either as part of yearly review or when an analytical change to the method is made, • Conducts all activities in a safe and efficient manner, • Performs other duties as assigned Qualifications Basic Minimum Qualifications • 5+ year HR/MS experience in a production laboratory, • At least 5 years experience related to performing extractions and/or instrumental chromatographic analyses utilizing wet chemical and chromatographic techniques) in a wide variety of matrices encountered in environmental testing., • Bachelor’s degree in chemistry, biology, physics or related degree concentration, • Authorization to work in the United States indefinitely without restriction or sponsorship, • Exceptional technical skills, including logical thinking and deductive reasoning; good work habits (e.g., cleanliness, efficiency, carefulness, effective organizational skills);, • High accuracy in recording and transcribing data;, • Personal maturity and sense of responsibility;, • Good written and oral communication skills;, • Ability to learn new methods and techniques;, • Willingness to follow instructions and comply with company policies;, • Consciousness of, and a positive attitude toward, quality control and safety procedures;, • Good understanding of chemical principles;, • Accurate management of numbers, both by hand and using a calculator;, • Set up and perform nonroutine standardized tests with minimal supervision;, • Demonstrated versatility, flexibility, and efficiency;, • Effective use of time while managing multiple priorities;, • Above satisfactory reasoning ability;, • Self-motivated to improve technical skills and operations;, • Superior leadership, organizational, and communication skills;, • Lead a project to a satisfactory conclusion on time;, • Consult with clients on work performed for them;, • Problem solving skills;, • Function under high stress levels; multitask;, • See cause-and-effect relationships;, • Retain large amounts of information Additional Information Compensation Range: $80,000 - $120,000 per year depending on level of experience and qualifications. Position is full-time, and exempt from overtime pay. Candidates must be available to work the following shift: We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options. We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: Company description: Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR 6.151 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

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: Sterile Manufacturing Associate The Sterile Manufacturing Associate is responsible for executing aseptic and cleanroom manufacturing operations in compliance with cGMP, regulatory standards, and internal SOPs. This role plays a critical part in ensuring the integrity and quality of sterile drug products manufactured at Nivagen. The position requires a high degree of attention to detail, adherence to gowning and aseptic techniques, and the ability to follow precise procedures. Responsibilities: • Perform aseptic manufacturing operations in Grade A, B, C, and D cleanroom environments, including formulation, filtration, filling, and visual inspection., • Set up, operate, and clean equipment such as vial/syringe fillers, autoclaves, and isolators under sterile conditions., • Comply with all gowning requirements and environmental control procedures to maintain sterile conditions., • Follow batch production records (BPRs), standard operating procedures (SOPs), and material handling protocols., • Support execution of media fills, process validations, and cleanroom qualification activities., • Participate in room and equipment sanitization activities, ensuring compliance with established cleaning frequencies., • Complete all training in a timely manner and maintain qualification for aseptic operations., • Accurately record all activities in cGMP documentation, ensuring data integrity., • Assist with investigations, deviations, CAPAs, and continuous improvement initiatives., • Collaborate with Quality, Validation, Engineering, and Tech Services as needed to ensure successful production runs. Education/Experience: • High School diploma or GED required; Associate's or Bachelor's degree in Life Sciences or related field preferred., • Experience in an aseptic or sterile pharmaceutical manufacturing environment preferred., • Strong understanding of aseptic technique, cleanroom behavior, and contamination control., • Ability to read and follow SOPs, batch records, and manufacturing instructions precisely., • Comfortable wearing full aseptic gowning (hoods, coveralls, gloves, booties, masks) for extended periods., • Detail-oriented with strong documentation and communication skills., • Ability to work independently and as part of a collaborative team., • Valid driver's license and acceptable driving record., • Legally authorized to be employed in the United States., • This role is an onsite role and requires daily commuting to and from the facility., • This role requires work in a controlled cleanroom environment with strict gowning and hygiene protocols., • Fulltime Employment, • $28 - $32 per hour (Based on Experience), • Annual Bonus eligibility, • Medical, Dental and Vision coverage, • PTO plan Nivagen Pharmaceuticals affords 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 DescriptionAbout CSNC The team at Community Spay Neuter Clinic is made up of highly trained, experienced animal health professionals who are compassionate about our mission to stop animal suffering. Every animal is treated with love as if it were our own. We believe the human-animal bond is precious and worth every effort to support it. The Opportunity The Doctor of Veterinary Medicine (DVM) at Community Spay Neuter Clinic is a critical role responsible for providing high-quality, compassionate, and efficient surgical and medical care for a large volume of canine and feline spay and neuter patients. This position requires a licensed veterinarian with expertise in high-volume surgical techniques, anesthesia management, and patient recovery, committed to promoting animal welfare through accessible spay/neuter services. The DVM will oversee all medical aspects of patient care and ensure adherence to best practices and regulatory standards. The role involves minimal administrative duties and generally no direct interaction with pet families, allowing the DVM to stay fully focused on surgical care. Job Details: Job Type: Full-time Expected hours: Approximately 32 per week, typically Monday - Thursdays, with flexibility as needed. Salary Range: $165,000–$195,000 - Depending on experience Benefits: • Medical, Dental, and Vision insurance – 100% employer-paid (for doctors), • Retirement plan, • Employee discount, • Flexible schedule, • Accrued paid vacation, • Paid sick leave, • Perform high-quality, high-volume spay and neuter surgeries for both canine and feline patients, adhering to established surgical protocols and aseptic techniques., • Conduct comprehensive pre-operative physical examinations to assess patient suitability for surgery and identify any potential risks., • Develop and implement appropriate anesthetic protocols, monitor patients throughout surgical procedures, and manage any anesthetic complications., • Oversee and direct post-operative patient care, including pain management, fluid therapy, and monitoring for recovery and complications., • Diagnose and treat minor medical conditions identified during patient intake or recovery, within the scope of a high-volume spay/neuter clinic., • Administer vaccinations, microchips, and other preventative treatments as required.Medical Compliance & Documentation:, • Adhere to all medical procedures and protocols, ensuring compliance with state veterinary board regulations, professional standards, and clinic policies., • Maintain accurate and thorough medical records for all patients, documenting examinations, procedures, medications, and client communications.Clinic Operations & Quality Assurance:, • Contribute to optimizing patient flow, surgical efficiency, and overall clinic operations., • Adhere to and provide input on the development and refinement of medical protocols, including anesthesia, pain management, and emergency procedures., • Maintain a sterile surgical environment and ensure proper sterilization of instruments., • Address client concerns related to medical care and provide clear, compassionate communication regarding patient status and post-operative instructions., • Doctor of Veterinary Medicine (DVM) or equivalent degree from an accredited university., • Current, active, and unrestricted veterinary license in the state of California.Experience:, • Minimum of 1-3 years of experience as a practicing veterinarian, with significant experience in high-volume spay/neuter surgery preferred., • Proven proficiency in performing surgical procedures on a high volume of canine and feline patients., • Demonstrated expertise in anesthetic management and patient monitoring.Skills & Abilities:, • Exceptional surgical skills and a strong commitment to surgical excellence and patient safety., • Proficient in anesthetic induction, maintenance, and recovery for a variety of patient types., • Excellent diagnostic and problem-solving abilities., • Outstanding communication and interpersonal skills, capable of interacting professionally and empathetically with clients and colleagues., • Ability to work efficiently and effectively in a fast-paced, high-volume environment while maintaining a high standard of care., • Meticulous attention to detail in record-keeping, medication administration, and surgical protocols., • Deep commitment to animal welfare, population control, and the mission of accessible spay/neuter services.Physical Demands & Work Environment:, • Ability to stand for extended periods, perform repetitive motions, and lift and move animals weighing up to 25 pounds independently, and heavier weights with assistance., • Comfortable working in an environment with exposure to animal dander, bodily fluids, cleaning chemicals, pharmaceutical agents, and anesthetic gases., • Requires manual dexterity and visual acuity for performing surgical procedures and examinations., • May involve exposure to zoonotic diseases. HXnWtE96Tl

Job DescriptionAbout CSNC The team at Community Spay Neuter Clinic is made up of highly trained, experienced animal health professionals who are compassionate about our mission to stop animal suffering. Every animal is treated with love as if it were our own. We believe the human-animal bond is precious and worth every effort to support it. The Opportunity The Doctor of Veterinary Medicine (DVM) at Community Spay Neuter Clinic is a critical role responsible for providing high-quality, compassionate, and efficient surgical and medical care for a large volume of canine and feline spay and neuter patients. This position requires a licensed veterinarian with expertise in high-volume surgical techniques, anesthesia management, and patient recovery, committed to promoting animal welfare through accessible spay/neuter services. The DVM will oversee all medical aspects of patient care and ensure adherence to best practices and regulatory standards. The role involves minimal administrative duties and generally no direct interaction with pet families, allowing the DVM to stay fully focused on surgical care. Job Details: • Job Status: Part-Time/ Hourly : 1-3 shifts per week, depending on your availability, • Schedule: Surgeries are performed Monday – Thursday and doctor’s work 8 hours shifts. Depending on the needs of the clinic, we may be able to accommodate the days that work best for you., • Medical, Dental, and Vision insurance – 100% employer-paid (for doctors), • Retirement plan, • Employee discount, • Flexible schedule, • Accrued paid vacation, • Paid sick leave Surgical & Medical Care: • Perform high-quality, high-volume spay and neuter surgeries for both canine and feline patients, adhering to established surgical protocols and aseptic techniques., • Conduct comprehensive pre-operative physical examinations to assess patient suitability for surgery and identify any potential risks., • Develop and implement appropriate anesthetic protocols, monitor patients throughout surgical procedures, and manage any anesthetic complications., • Oversee and direct post-operative patient care, including pain management, fluid therapy, and monitoring for recovery and complications., • Diagnose and treat minor medical conditions identified during patient intake or recovery, within the scope of a high-volume spay/neuter clinic., • Administer vaccinations, microchips, and other preventative treatments as required.Medical Compliance & Documentation:, • Adhere to all medical procedures and protocols, ensuring compliance with state veterinary board regulations, professional standards, and clinic policies., • Maintain accurate and thorough medical records for all patients, documenting examinations, procedures, medications, and client communications.Clinic Operations & Quality Assurance:, • Contribute to optimizing patient flow, surgical efficiency, and overall clinic operations., • Adhere to and provide input on the development and refinement of medical protocols, including anesthesia, pain management, and emergency procedures., • Maintain a sterile surgical environment and ensure proper sterilization of instruments., • Address client concerns related to medical care and provide clear, compassionate communication regarding patient status and post-operative instructions., • Doctor of Veterinary Medicine (DVM) or equivalent degree from an accredited university., • Current, active, and unrestricted veterinary license in the state of California.Experience:, • Minimum of 1-3 years of experience as a practicing veterinarian, with significant experience in high-volume spay/neuter surgery preferred., • Proven proficiency in performing surgical procedures on a high volume of canine and feline patients., • Demonstrated expertise in anesthetic management and patient monitoring.Skills & Abilities:, • Exceptional surgical skills and a strong commitment to surgical excellence and patient safety., • Proficient in anesthetic induction, maintenance, and recovery for a variety of patient types., • Excellent diagnostic and problem-solving abilities., • Outstanding communication and interpersonal skills, capable of interacting professionally and empathetically with clients and colleagues., • Ability to work efficiently and effectively in a fast-paced, high-volume environment while maintaining a high standard of care., • Meticulous attention to detail in record-keeping, medication administration, and surgical protocols., • Deep commitment to animal welfare, population control, and the mission of accessible spay/neuter services.Physical Demands & Work Environment:, • Ability to stand for extended periods, perform repetitive motions, and lift and move animals weighing up to 25 pounds independently, and heavier weights with assistance., • Comfortable working in an environment with exposure to animal dander, bodily fluids, cleaning chemicals, pharmaceutical agents, and anesthetic gases., • Requires manual dexterity and visual acuity for performing surgical procedures and examinations., • May involve exposure to zoonotic diseases. qzT9eRzfIy

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 the 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 3900 Duckhorn Dr, Sacramento, CA 95834. About the Job: Title of the Position: Automation Technician The Automation Technician ensures reliable operation of sterile pharmaceutical manufacturing systems by installing, maintaining, calibrating, and troubleshooting automation components, process instrumentation, drives, motors, control devices, clean utility systems, and aseptic production equipment. The role supports continuous and compliant operations under cGMP, FDA 21 CFR Part 11, and cleanroom standards. Responsibilities: • Install, maintain, calibrate, and troubleshoot sensors and transmitters for pressure, temperature, flow, level, pH, conductivity, and environmental monitoring., • Support in performing GMP‑compliant calibrations with complete traceability and accurate documentation., • Install, maintain, and troubleshoot motors, pumps, fans, drives, control devices, and sterile manufacturing equipment., • Perform conduit bending, cable routing, wire pulling, cable termination, tray installation, and equipment connections in accordance with plant procedures., • Install and modify control panels, junction boxes, and instrumentation assemblies., • Diagnose issues in circuits, protection components, sensors, actuators, drives, and automated machines., • Use diagnostic tools such as multimeters, clamp meters, insulation testers, and calibration instruments., • Support PLC, HMI, SCADA, BMS, and EMS platforms, including troubleshooting and system checks., • Conduct loop checks, functional tests, FAT/SAT, commissioning, and support validation activities (IQ/OQ/PQ)., • Maintain and troubleshoot systems for PW, WFI, Clean Steam, CIP/SIP, HVAC/HEPA controls, and aseptic filling/packaging operations., • Read and interpret P&IDs, wiring diagrams, schematics, ladder logic, and loop drawings., • Maintain cleanroom support systems, including differential pressure controls, HEPA filtration, and environmental monitoring., • Ensure compliance with cGMP, cleanroom classification requirements, FDA 21 CFR Part 11, and data integrity principles., • Perform preventive, corrective, and predictive maintenance., • Conduct root‑cause analysis and implement CAPA actions., • Ability to work rotating, weekend, or extended shifts., • Exposure to high‑noise areas (PPE provided)., • Frequent work on mezzanine floors, elevated platforms, ladders, and step‑ups., • Work inside aseptic cleanrooms and controlled environments (ISO 5/7/8) wearing full gowning., • Exposure to hot, cold, humid, or pressurized utility systems such as PW, WFI, Clean Steam, and HVAC units., • Occasional work in tight spaces, behind panels, or equipment enclosures., • Regular use of PPE, including sterile gowning, gloves, and eye protection. Education: Minimum 5 to 10 years of professional experience in the field of pharmaceutical or manufacturing industry. Knowledge, Skills, and Abilities: Functional: • Strong troubleshooting skills across sensors, transmitters, motors, drives, actuators, control components, automated machinery, and process systems., • Experience with conduit bending, tray installation, cable pulling, wire routing, cable dressing, and termination., • Proficiency in installing and modifying panels, junction boxes, and equipment assemblies., • Skilled in using multimeters, clamp meters, insulation testers, and calibration devices., • Ability to install, connect, and terminate control wiring and instrument cabling for field devices., • Understanding of circuits, drives, starters, protection components, actuators, and control system diagnostics., • Ability to read and interpret P&IDs, schematics, wiring diagrams, ladder logic, and loop documentation., • Knowledge of GMP requirements, sterile manufacturing, cleanroom practices, aseptic operations, and validation processes., • Strong documentation discipline, attention to detail, and audit readiness., • Result oriented, • Innovative thinking, • Time Management, Professional Work Conduct at all times, • Problem-solving ability & High level of self-motivation, • Strong interpersonal relationship skills, • Valid driver's license and acceptable driving record, • Legally authorized to be employed in the United States, • Competitive Salary: $70,304 - $80,000, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, including 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.

Overview: Our client, a Global Fortune 50 organization and one of world’s largest distributors of healthcare systems, medical supplies & Pharmaceutical products, seeks an accomplished Pharmacy Technician Job Title: Pharmacy Technician Location: 970 Riverside Parkway, Suite 20, West Sacramento, CA 95605 Duration: 4 months with possible extension Pay Rate: $26.00 per hour (W2) Work Schedule: • Monday – Friday, 1:30 PM – 10:00 PM, • After ~4 weeks, must be flexible to shift to Sunday – Thursday, • Sunday: 8:30 AM – 5:00 PM, • Weekdays remain 1:30 PM – 10:00 PM, • Mandatory overtime as required by business needs Must-Have Requirements: • High School Diploma or equivalent, • Active California Pharmacy Technician License (required), • Minimum 1-5 year of experience as a Pharmacy Technician (externships/programs not counted), • Ability to work onsite and adapt to changing schedules, • Must have reliable transportation to report onsite Job Description: The Pharmacy Technician will support a high-volume, automated central fill pharmacy operation. Under the supervision of a licensed Pharmacist, this role is responsible for preparing, packaging, and distributing medications accurately and efficiently while maintaining strict compliance with quality, safety, and HIPAA standards. The ideal candidate thrives in repetitive production work, maintains exceptional attention to detail, and contributes positively in a team-based environment. Responsibilities: • Accurately fill prescription vials with tablets and capsules, • Read computer-generated screens to verify medication, dosage, strength, and quantity, • Perform basic math calculations for prescription quantities, • Replenish automated dispensing cells and manage bulk product handling, • Scan barcodes and enter lot and expiration data using handheld scanners, • Conduct quality checks to prevent cross-contamination and identify expired/damaged products, • Complete weekly cycle counts and inventory audits, • Assist in root cause analysis of inventory discrepancies, • Prepare cold-chain and specialty prescriptions following handling requirements, • Pack and ship prescriptions per SOPs, • Ensure compliance with HIPAA, federal, and state pharmacy regulations, • Identify, resolve, and escalate issues appropriately to management Required Qualifications: • High School Diploma or equivalent, • Active California Pharmacy Technician License (required), • National PTCB Certification (preferred), • Minimum of 1–5-year pharmacy experience (retail, central fill, or mail order), • Ability to lift up to 40 lbs., stand for long durations, and perform repetitive tasks, • Strong math and reading skills, • Ability to perform under pressure and multitask efficiently, • Excellent attention to detail and focus to prevent errors, • Experience operating pallet jacks, hand trucks/dollies, and scanning equipment, • Commitment to patient privacy and HIPAA compliance Recruiter Contact Info Jatin Rattan E-mail: I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you. Company Overview: Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward. Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.

EHS Manager Kelly® Science & Clinical is seeking an EHS Manager for a direct-hire position at a cutting-edge Client in Sacramento, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. Salary:$90,000–$100,000 per year Schedule: Full-time Overview Our client is an industry-leading 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, they have remained steadfast in its commitment to excellence, integrity, and respect for people. As an Environmental Health and Safety (EHS) Analyst, you will support the development, implementation, and ongoing enhancement of Client’s EHS programs across all facilities. This role ensures compliance with OSHA, EPA, DEA, FDA, and state regulatory standards, promotes a safe and environmentally conscious workplace, and drives a culture of proactive risk management. You will collaborate closely with Manufacturing, QA, Facilities, and Engineering teams to support daily operations, audits, and training while contributing to sustainability and safety initiatives. Responsibilities • Maintain and manage EHS documentation including SDS, hazardous waste manifests, injury logs, training records, and regulatory permits., • Coordinate EHS training sessions on safety, chemical handling, emergency response, and hazardous material management., • Support execution of company-wide EHS programs, procedures, and policies in compliance with regulatory standards (OSHA, EPA, DEA, Cal/OSHA, etc.)., • Conduct routine inspections and internal audits to identify hazards and ensure corrective actions are implemented., • Monitor waste generation, recycling, air emissions, and water usage and support environmental sustainability efforts., • Track and report on key EHS metrics and submit required reports to regulatory agencies., • Investigate incidents, near-misses, and environmental spills and support root cause analysis and CAPA implementation., • Assist with DEA security and controlled substance compliance (21 CFR Part 1301)., • Contribute to cross-functional initiatives for continuous improvement in safety culture and environmental responsibility., • Collaborate in planning for emergency preparedness, evacuation drills, and risk assessments., • Any other duties assigned by Supervisor. Qualifications Education & Experience: • Bachelor’s degree in Environmental Science, Occupational Safety, Chemistry, Industrial Hygiene, or related discipline., • Familiarity with environmental reporting, hazardous waste handling, and safety data sheet management., • Ability to work independently and manage multiple priorities in a fast-paced environment., • Proficiency in Microsoft Office Suite and EHS management software., • Working knowledge of OSHA, EPA, DOT, and DEA regulations., • Strong analytical and problem-solving skills with attention to detail., • Effective verbal and written communication skills for cross-functional coordination and training., • Experience with incident investigation and documentation practices., • Must live or be willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius). Benefits • Medical, dental, and vision coverage, • Paid time off plan, • 401k savings plan, • Yearly bonus eligibility What happens next Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

The Maintenance Supervisor is a key operational role within the Pharma Services business. The role will be responsible for contributing to the achievement of business unit KPIs through supporting operational and engineering teams in the operation and maintenance of facilities, utilities and process equipment throughout their lifecycle. The role will be directly responsible for the management of the Maintenance Engineering function at our Sacramento location. JOB SPECIFIC RESPONSIBILITIES: • Responsible for routine activity in the shift to operate and maintain different facility equipment’s like Utility systems, HVAC and other system., • Ability to supervise the shift activity, train the team and strong knowledge in trouble shooting the facility and process equipment’s., • Deep knowledge in the engineering and maintenance activity of the facility equipment’s of pharmaceutical industry – Fill finish / sterile fill finish., • Reduce maintenance costs whilst simultaneously improving asset reliability and availability by implementing improved maintenance techniques through the use of appropriate improvement tools (E.g. reliability centered maintenance, risk-based approach, lean/six sigma etc.)., • Provide technical expertise and advice on process equipment’s like bag, vial and PFS filling lines, formulation systems, autoclaves etc. Deep knowledge in trouble shooting the problems in right approach to minimize the shut down time., • Manage a skilled, multi-discipline maintenance work force, facilitating their daily operations and task execution, training, and personal development, • Perform area, equipment, and item inspections to ensure regulatory and quality compliance, • Performing PM activity of all the process equipment’s and facility equipment’s., • Responsible for operation and maintenance of boilers, hot water generator, chiller, air compressor, AHU, PW generation and distribution, WFI storage and distribution, pure steam generation and distribution., • Support facilities supervision in construction, maintenance, troubleshooting, and repair of equipment and utilities., • Oversee electrical and mechanical system startup and commissioning and coordinate with subcontractor and construction management activities., • Develop maintenance and calibration programs, with emphasis on planning/scheduling and preventive/predictive maintenance., • Maintain accurate paper and electronic records for operations including supply inventories, reports, mechanical equipment lists, purchase orders, warranties, parts lists, operating instructions, and other documents pertaining to preventive maintenance and repairs., • Preparation engineering SOP and make sure the team follows it as per cGMP. Here Is What You Need (Minimum Requirements) • Applicant must have a bachelor's degree with at least 8 years of experience; OR a master's degree with 5+ years of experience., • Experience in engineering and maintenance in the pharmaceutical or biotech industry., • 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., • Strong organizational skills and attention to detail. PHYSICAL/MENTAL REQUIREMENTS • 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.). NON-STANDARD WORK SCHEDULE, OR ENVIRONMENT REQUIREMENTS • This role is primarily different shift, with 24/7 support of manufacturing as maintenance issues arise., • Work Location Assignment: On Premises

A pharmaceutical company in Sacramento seeks a Director of Quality Control to lead QC operations and regulatory compliance.