Quality assurance specialist jobs in Temecula, CA - 396 jobs

Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (*************** Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (**************** with a mission to provide the highest quality materials to niche life science markets worldwide. Since its inception, Kinovate has grown to become the market leader in solid support in the oligonucleotide synthesis field. We are bringing the most creative minds in science and technology to develop medical discoveries and breakthroughs. Our customers are well-known in the biotechnology industry. We are in a growth phase within ISO work environment and leading towards a GMP Certification. KLS is seeking extraordinary people to join the team. KLS is proud to be an equal employment opportunity employer. Why Work Here Great place to work. Small subsidiary of large international company headquartered in Japan. Generous discretionary bonuses. Health, dental, vision, life, and disability insurance effective from date of hire. Additional benefits include 401(k), 3 weeks vacation in your first year, 12 paid yearly holidays, 5 paid sick days, tuition reimbursement and more. JOB SUMMARY: Under strategic leadership, sustain the improvement of the Quality Management Systems (QMS) and manages the development of quality assurance & systems staff. Utilize the following industry standards to drive high-quality products: Current Good Manufacturing Practice (cGMP), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and International Organization for Standardization (ISO). Facilitate employee relations issues including coaching, mentoring, and disciplining including performance evaluation of employees. Provides strong leadership to motivate, guide and inspire employees to meet the organization's business objectives with production. Lead the implementation phase of MasterControl, ensuring successful implementation, and post-implementation management. ESSENTIAL DUTIES and/or RESPONSIBILITIES: Partners with leadership to develop the Quality Management System (QMS) and ensure it is compliant with relevant regulations, including ISO 9001, 21 CFR Part 210 and 211, ICH, and other applicable national and international regulatory guidelines.Ensure the QMS always remains in an auditable state. Oversees the daily operations of the QMS, ensuring it runs efficiently and in compliance with quality standards. This includes managing critical quality systems processes such as Incoming Raw Material Receipt, Raw Material Review/Disposition, Final Product Review/Disposition. Manages quality events and investigations including but not limited to Deviations, CAPA, Change Control, OOS, OOT, Customer Complaints, including leading and facilitating cross-functional meetings to ensure proper assessments and actions. Ensures QA review of Validation/Qualification activities including protocols, execution, and reports. Upholds timely response to events and on-the-floor QA support(MQA), including ensuring the MQA program is tracked and measurable. Leads the transition of QMS programs, such as Quality Events (Deviation, CAPA, Change Control, OOS, OOT), Audits and Supplier Qualification transition into Master Control, and serves as the System Administrator. Administers post-implementation management of MasterControl, including, but not limited to, system optimization, performing troubleshooting support, managing software updates, and continuously improving system functionality to meet evolving regulatory needs. Reports key metrics for QA Operations turnaround times and Quality Events. Contributes to the continuous improvement initiatives related to the QMS, collaborating with cross-functional teams to optimize quality processes. Analyze quality data and metrics to identify trends, root causes, and areas for process improvement within manufacturing and quality control activities. Develops standard operations and other quality documents related to QMS and ensure all documents meet regulatory requirements and internal standards. Supervises and develops a team providing guidance, training, and support to ensure compliance with regulatory standards and best practices. Mentors and develops a team of the QA team, fostering an environment of accountability and growth. Ensures cross-functional collaboration and provide effective leadership managing the QMS processes and ensures effective employee relations. Facilitates training initiatives to ensure that team members are adequately prepared to handle QMS functions and sustain a flexible workforce. Fosters a culture of continuous improvement, supporting staff development and efficiency improvements within the quality systems team. Conducts performance reviews for direct reports. Institutes timely corrective actions and interfaces with Leadership and HR in developing disciplinary actions up to and including terminations. Administers time-keeping functions to track absenteeism; approves timecards on a bi-weekly basis. SUPERVISOR RESONSIBLITIES: Quality Assurance Associate Quality Assurance Specialist Sr. Quality Assurance Specialist MINIMUM EDUCATION and/or EXPERIENCE: Bachelor's degree in a scientific discipline; and five (5) years' directly related experience in a Good Practice (GXP) or ISO manufacturing-controlled environment or equivalent combination of education and experience. Experience in transitioning from paper based to electronic QMS. KNOWLEDGE, SKILLS and/or ABILITIES: Working knowledge of pharmaceutical industry concepts, as well as analytical methods and writing skills, including documenting manufacturing processes, a plus. Familiarity in Lean or Six Sigma, a plus. Strong Knowledge of quality management principles and practices, including ISO 9001 and cGMP standards. Proficient in the use of quality management software with experience in implementing or managing MasterControl being highly desirable. Experience conducting technical investigations with formal root cause analysis tools. Prior supervisory experience, preferred. Knowledgeable of change control, validation/qualification, and method development and tech transfer. Strong knowledge of formal root cause analysis and risk assessment tools. Ability to lead or facilitate investigations and/or risk assessments. Strong application of critical thinking skills along with problem solving and creative skills to identify manufacturing issues for continuous improvement. Strong multi-tasking skills, flexibility in responding to rapidly changing, dynamic processes and demands/pressures in a fast-paced environment. Strong ability to verbally communicate across functional organizational groups, provide high-level customer service through effective interpersonal skills and conflict resolution, including communicating with equipment suppliers to obtain input on equipment modification and improvement. Microsoft Office Suite software applications such as Excel, Word, Power Point, and other enterprise software applications such as Net Suite, LIMS, and Familiarity with statistical analysis tools. Strong language skills with the ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or government regulations. Write clear processes, manuals and reports for management review and present technical information in understandable terms and respond to questions from groups of customers, employees and/or public. Work independently as well as in a small and/or large group and foster cooperation in a team environment using interpersonal skills to document working knowledge. Work in a detail-oriented environment with strong follow-up, follow-through, and organizational skills. CERTIFICATES and/or LICENSES: American Society for Quality Certified, a plus. Certified Quality Engineer, a plus. Certified Quality Auditor, preferred. PHYSICAL DEMANDS and/or WORK ENVIRONMENT: (Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) Works in a typical office environment with prolonged periods in front a computer entering or researching data. Regularly required to sit; use hands to finger, handle or feel and talk or hear. Availability and willingness to travel if required for audits, inspection, vendor management or if requested to visit or attend a business transaction as legal agent of the company. Must be able to work extended hours per the demands of the business.

QSC is creating exceptional, people-centric experiences with the perfect balance of technology and creativity. Q-SYS, our innovative full stack audio, video and control platform, unifies data, devices and a cloud-first architecture, empowering organizations to deliver transformative AV experiences across built spaces. Building on the QSC legacy, QSC Audio delivers audio technology that empowers live entertainers and sound reinforcement professionals with the confidence to create and deliver memorable experiences for their audiences. Atrius, Distech Controls and QSC are part of the Acuity Intelligent Spaces (AIS) business segment. Our mission is to make spaces smarter, safer and greener through our strategy of connecting the edge with the cloud using disruptive technologies that leverage data interoperability. Acuity Inc. (NYSE: AYI) is a market-leading industrial technology company. We use technology to solve problems in spaces, light and more things to come. Through our two business segments, Acuity Brands Lighting (ABL) and Acuity Intelligent Spaces (AIS), we design, manufacture, and bring to market products and services that make a valuable difference in people's lives. We achieve growth through the development of innovative new products and services, including lighting, lighting controls, building management solutions, and an audio, video and control platform. We focus on customer outcomes and drive growth and productivity to increase market share and deliver superior returns. We look to aggressively deploy capital to grow the business and to enter attractive new verticals. Acuity Inc. is based in Atlanta, Georgia, with operations across North America, Europe and Asia. The Company is powered by approximately 13,000 dedicated and talented associates. Visit us at ****************** Job Summary The Manager, Quality Systems is tasked to lead our quality excellence initiatives and ensure that our products meet the highest standards of quality, reliability, and performance. Responsible for implementing and managing quality systems compliance to ISO standards and utilizing best industry practices for quality in design and supply chain for driving continuous improvement in quality process across the organization. The right person for this role is comfortable in setting and driving step-change improvement and has experience managing quality systems for electronics. The individual

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Clinical Quality Assurance Specialist will participate in the activities in support of the GCP and the Quality Assurance departments at Arrowhead to ensure compliance with GCP standards. This includes support in investigator audit programs, risk management plans, regulatory inspections, generating metrics for continuous improvement, and quality events while collaborating cross-functionally to uphold clinical trial quality and regulatory compliance. Key responsibilities include assisting in GCP Quality Event management (non-conformances, deviations, CAPAs, SCARs), contributing to risk-based audit planning, support in audits and inspections, procedural reviews and collaborating closely with the Clinical Operations team to ensure GCP compliance and data integrity. Responsibilities Develop and maintain clinical quality study risk plans and maintain updates in the Quality Management System (QMS). Collect site metrics for selection of investigator site audits while analyzing and reporting trends. Lead and participate in internal audits to identify gaps, ensure adherence to policies, and drive corrective actions. Assist with audit-related data entry in the QMS and documentation to maintain accurate and organized records and do develop dashboards for internal sharing. Conduct periodic reviews of SOPs to verify compliance with regulatory requirements and organizational standards. Support in the issuance, tracking and completion of deviations, SCARs (supplier corrective action requests) and CAPAs. Provide QA support for clinical study programs with GCP compliance, as needed. Assist during health authority inspections, including document management and logistical coordination. Support and contribute to risk management analysis efforts associated with GCP functions. Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level. Communicate risk management mitigations and activities to the Manager Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams. Facilitate ongoing quality improvement through communication of audit results and CAPAs Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Serious Breaches). Keep up to date with all related quality legislation and compliance issues. Requirements: Bachelor's degree in a science discipline is required. 3 years of relevant experience in a regulated environment with preference to quality assurance, auditing and/or GCP experience. 2 years of relevant experience in GxP function providing Quality and Compliance oversight. Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; San Diego, CA) Preferred: Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations and ICH guidelines. Prior experience with use of an electronic document management system in a regulated environment is preferred (Veeva). Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment) is beneficial. California pay range $80,000-$95,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Under direct supervision of the Quality Systems & Regulator Compliance Department management, the Quality Assurance Auditor/Inspector is primarily responsible for auditing manufacturing operations and quality systems for compliance with Good Manufacturing Practices, Good Documentation Practices, and other company's established manufacturing operations and quality policies. ESSENTIAL FUNCTIONS: Responsibilities include but are not limited to: • Enforce Current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs) at all stages of the manufacturing process and in all places within the manufacturing areas. • Conduct routine “walk-through” in the manufacturing areas and other specified areas (such as restrooms, and break-rooms) to ensure that good housekeeping practices and good hygiene practices, which could affect the safety and quality of manufactured products, are followed. • Verify that all raw materials and packaging components are properly received, stored and segregated (allergen vs. non-allergen; organic vs. non-organic, etc.) in the warehouse for raw materials and packaging components. • Verify that processing equipment has been properly cleaned and sanitized in the staging/weighing rooms, compounding/batching rooms, powder blending rooms, filler and packaging rooms, etc. • Audit the weighing/staging process to ensure that the correct raw materials are used and in correct amounts as specified in the Ingredients Batch Record. • Audit the compounding/batching process to ensure that all raw materials allocated to the batch are indeed used and added to the batch in the sequence specified in the Manufacturing Instructions Batch Record. • Collect in-process samples from the batch (as specified) and perform all required tests (pH, Brix, sensory evaluation, etc.) before releasing the batch for further processing (such as thermal processing) and packaging. • Collect samples of finished products (test samples, stability samples, and reserve samples), conduct specified testing and report testing results. • Perform all applicable line clearance and inspections which may include measuring the product fill levels or fill weights, proper label application and cap torque, inkjet legibility on bottles and cases, and proper pallet configuration. • Maintain all Quality and Production paperwork including bottle and cap tracking logs, shrink sleeve tracking logs, area line clearances, room and equipment cleaning and sanitation, issuing of product specification sheets, etc. • Verify that all quality control instruments (balances, pH, refractometers, thermometers, etc.) are properly calibrated and performing up to specifications. • Sampling finished products for quality control laboratory, special testing such as stability studies, customer samples and maintaining reserve samples. • Perform AQL inspections of finished product when rework is conducted or as directed by Quality Systems & Regulatory Compliance Department Management. • Monitor the effectiveness of cleaning & sanitation (visual observation as well as using ATP bioluminescence method). • Monitoring the concentration of sanitizers such as peracetic acid (PAA), QUAT and ozone as applicable to ensure that the levels do not exceed or fall below specifications. • Assist in environmental monitoring (swabbing and air sampling) and pest control inspection. • Perform other duties as determined by the Quality Systems & Regulatory Compliance Department Management. REQUIRED EDUCATION / EXPERIENCE / SKILLS: • Bachelor's degree in food science and technology, biology, microbiology or other related disciplines or equivalent work experience (High School Diploma with at least 3 years of work experience in related field or industry) • Work experience in quality control/quality assurance operations in food, dietary supplement or pharmaceutical industry • Experience with GMP regulations and Good Documentation Practices • Sample collection experience is a plus.

About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva's lead program, AlloNK , is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren's Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva's pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell's NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit ****************** Job Summary: This position is responsible for cGMP auditing and supplier management activities at Artiva. Duties/Responsibilities: Perform GMP/GDP audits in accordance with the external and internal audit program. Support GXP audits (GLP, GCP, GCLP), as necessary. Perform Drop-In GMP Internal audits. Create and maintain audit schedules. Track audit responses to completion. Oversee and maintain the supplier qualification program. Support the creation and execution of Quality Agreements with suppliers. Update databases, prepare metrics, identify and communicate trending and tracking of audits and related supplier management activities. Support audits by regulatory or state agencies and partners. Support QA review of Analytical Development and Process Development data and reports, as needed. Follow applicable regulations, including FDA, ISO, ICH, company policies and procedures. Support other QA department needs as identified by management. Requirements: Bachelor's degree or a combination of relevant education and applicable job experience 5+ years' experience in an FDA regulated industry and expert knowledge of CGMP regulations Certified Quality Auditor credential is a plus. Ability to adapt quickly to shifting needs and/or priorities Able to interface well with all levels of personnel Excellent communications skills, both written and verbal and a high degree of professionalism Exceptional attention to detail Flexibility to travel Why you should apply: We have a fantastic team and philosophy! We are passionate - We deeply care about our team, our science, and improving the lives of autoimmune and cancer patients. We are tenacious - we are laser-focused on our mission and undeterred in our commitment to make cell therapies broadly accessible to patients with autoimmune disease and cancer. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive - committed to the diversity of our team and ensuring that all voices are heard. In addition to a great culture, we offer: · A beautiful facility · An entrepreneurial, highly collaborative, and innovative environment · Comprehensive benefits, including: Medical, Dental, and Vision Group Life Insurance Long Term Disability (LTD) 401(k) Retirement Plan with match Employee Assistance Program (EAP) Flexible Spending Account (FSA) Paid Time Off (PTO) Company paid holidays, including the year-end holiday week Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $100,000 - 120,000. Exact compensation may vary based on skills and experience.

The J.R. Simplot Company is a diverse, privately held global food and agriculture company headquartered in Boise, Idaho. We are a true farm-to-table company with an integrated portfolio including food processing and food brands, phosphate mining, fertilizer manufacturing, farming, ranching and cattle production, and other enterprises related to agriculture. Summary This role exists to ensure that quality attributes throughout the facility are evaluated in a thorough and consistent manner. This role will maintain an integrated quality grading program to include upstream grading, sensory grading and finished product grading to ensure products meet customer, regulatory and Company standards. This role will also audit, train, test, evaluate, define and participate in the development of product grading policies and procedures for the factory quality systems. Key Responsibilities Manage operator and technician proficiency program. Maintain necessary level of communication with team members and other support groups and does so in a participative management style conducive with operational goals. Ensure self-compliance with Company policies and plant procedures, and the Collective Bargaining Agreement. Maintain Company standards for safety, quality, food safety, sanitation and GMPs. Evaluate customer or interplant samples prior to shipment or as needed. Performs required quality checks and sampling for all lines and ensures that they are conducted in compliance with established procedures and specifications. Conduct product grading, sensory evaluation and analytical procedure training to hourly and management personnel. Participate in investigating customer complaints, out-of-specification and failure investigations and recommend corrective actions. Utilize computer and computer programs to communicate, document, and track shift information and ensures that all documents and reports are completed accurately in a timely and efficient manner. Ensure that additional accountabilities required by management are handled in a manner necessary to meet operational standards. Conducts frozen waste sampling, reject ratio and line flow length and ensures that recovery and quality is maximized. Typical Education Required Certifications Must obtain Sensory Grading Certification within 2 months. Other Information Quality Assurance or Auditing experience preferred. A combination of education and experience will be considered. Must obtain Sensory Grading Certification within 2 months. Must be able to work around and consume products containing soy, wheat, and dairy. Shift: 6am-6pm Job Requisition ID: 23913 Travel Required: None Location(s): GF Plant - Ontario Country: United States **The J.R. Simplot Company is proud to be an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, national origin, ancestry, age, sex, gender, gender identity, gender expression, genetic information, physical or mental disability, medical condition, sexual orientation, military or veteran status, marital status, or any other protected status. **

Cooley is seeking a Document Specialist to join the Document Processing team. The Document Processing Specialist is responsible for providing document production and processing support.The Document Processing Specialist will work together with other document processing specialist and/or proofreader team members across both domestic/international locations and schedules in an effort to provide the highest level of customer service and quality in an effort to provide the highest level of customer service and quality. Responsibilities include, but are not limited to the following: Schedule for Work Week : Sunday-Thursday: 10:00 PM-6:30 AM (Pacific Time) Friday: OFF Position responsibilities: Create new documents and revise existing documents in Microsoft Word, Excel, PowerPoint, and Visio using conversion of electronic file or new input typing, or by downloading and reformatting documents from Internet resources such as EDGAR databases Reformat existing documents into Cooley templates and standard or custom formats Convert documents to Word, Excel, PowerPoint and Visio from a variety of applications and file formats, such as pdf Transcribe analog or digital dictation files Proofread all edits made or word-for-word for new input, or conversion projects for accuracy Troubleshoot issues in multiple software applications, including Word, Excel and PowerPoint Answer hotline calls, proxy on to user workstations and respond and resolve user document and software issues Create fill-in forms in Acrobat Create charts, graphs, tables and spreadsheets as requested Use email, including email with multiple attachments Transfer documents to/from secure file transfer platforms Conduct Internet, intranet, network and archive searches, as requested Download/Save/Print to PDF from various Data Sites Mark and generate Table of Contents and Table of Authorities (utilizing Best Authority) Perform redlines using Litera Compare and native Word Log work and cost recovery information All other duties as assigned or required Skills & experience: Required: After orientation at Cooley LLP, exhibit proficiency in the Microsoft Office suite, iManage and other firm applications Available to work overtime and flexible schedule, as required Knowledge of Microsoft Office Suite, iManage, Visio, Acrobat, IntApp, eDictation, Litera, Compare and Best Authority Fast and accurate typing General understanding of personal computers Previous experience supporting multi-locations and time zones Previous legal document processing experience 1. Document Specialist I: Minimum 1+ year prior document processing experience 2.Document Specialist II: Minimum 5+ years prior document processing experience with proven software knowledge and document expertise Cooley offers a competitive compensation and excellent benefits package and is committed to fair and equitable employment practices. EOE. The expected hourly pay range for this position with a work schedule of 40 hours per week is $32.00 - $56.50 ($66,560.00 - $117,520.00 annually). Please note that final offer amount will be dependent on geographic location, applicable experience and skillset of the candidate. We offer a full range of elective benefits including medical, health savings account (with applicable medical plan), dental, vision, health and/or dependent care flexible spending accounts, pre-tax commuter benefits, life insurance, AD&D, long-term care coverage, backup care for children and/or adults and other parental support benefits. In addition to elective benefit options, benefited employees receive firm-paid life insurance, AD&D, LTD, short term medical benefits as well as 20 days of Paid Time Off (“PTO”) and 10 paid holidays each year. We provide generous parental leave and fertility benefits. New employees will attend a detailed benefit orientation to learn more about our many benefits and resources.

Connexion's mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve. Title: Quality Assurance Coordinator Hiring Organization: Connexion Systems & Engineering Compensation, Benefits, and Employment Type Duration: 5+ month contract, potential for extension or conversion Pay rate: $35-$37.10/hr Job Location: San Diego, CA Schedule: Mon - Fri, 1 st shift Job#: bh18414 Description: We're supporting a fast-growing life sciences organization in identifying an experienced Quality Assurance Coordinator to join their Quality team. This is an excellent opportunity for someone looking to deepen their experience in regulated environments, contribute to a robust Quality Management System, and support an upcoming ERP system rollout. About the Role The QA Coordinator will play a key role in supporting Quality Assurance activities, document control, and QMS compliance within a dynamic and collaborative environment. This individual will contribute to the implementation, maintenance, and continual improvement of the organization's Quality Management System (QMS) and will be involved in cross-functional interactions across Manufacturing, R&D, Supply Chain, IT, and more. Key Responsibilities Process and manage document control requests; support training activities within the eQMS (SmartSolve). Assist with QA tasks related to the company's new ERP system implementation. Collaborate across multiple quality processes, including change control, nonconformance, complaints, CAPA, supplier quality, audits, risk management, product release, and design control. Ensure compliance with quality procedures and maintain complete, accurate quality records. Generate, review, and maintain QMS documentation. Track and report QMS performance metrics, KPIs, and data for monthly and management reviews. Support preparation and execution of internal audits and external regulatory/customer audits. Participate in QMS system enhancements and expanded use of eQMS features. Coordinate daily tasks, training plans, and overall workflow to ensure timely completion. Provide cross-functional support and serve as a resource on critical QMS processes. Perform additional QA-related tasks or special projects as needed. Required Skills & Qualifications Understanding of quality standards and regulations such as ISO 13485, MDSAP, FDA 21 CFR 820, and EU IVDD. Proficiency with MS Office tools (Word, Excel, PowerPoint) and Adobe Acrobat. Strong organizational skills, attention to detail, and ability to manage multiple priorities. Strong communication and interpersonal skills. Ability to work independently with minimal supervision. Quick learner with solid problem-solving abilities. Education & Experience Bachelor's degree in a scientific discipline or equivalent experience. At least 1 year of Quality Assurance experience in a regulated environment (GMP/GLP preferred). Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly. You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line. If you are active in a job search but this job is not for you, please reach out to *************************. We would be glad to help you find the perfect job

The Assurance Experienced Associate will be responsible for preparing financial statements with disclosures, applying basic areas of GAAP as necessary and documenting, validating, testing, and assessing various control systems. This position may also be involved in reviews and agreed-upon procedure engagements. Job Duties: Control Environment: * Applies knowledge and understanding of the collective effect of various factors on establishing or enhancing effectiveness, or mitigating the risks, of specific policies and procedures by: * Identifying and considering all applicable policies, laws, rules, and regulations of the firm, regulators, or other authoritative bodies as part of engagement team * Making constructive suggestions to improve client internal controls and accounting procedures * Documenting and validating the operating effectiveness of the clients' internal control system GAAP: * Applies knowledge and understanding of governing principles; applying these principles to client transactions; and documenting and communicating an understanding and application of these principles by: * Providing support of conclusions with authoritative literature * Drafting basic sets of financial statements with disclosures * Researching intermediate areas of accounting and forming an initial opinion on the correct treatment independently GAAS: * Applies knowledge and understanding of professional standards; application of the principles contained in professional standards; and the ability to document and communicate an understanding and application of professional standards on an engagement by: * Developing and applying an intermediate knowledge of auditing theory, a sense of audit skepticism, and the use of BDO audit manuals * Applying auditing theory to various client situations * Documenting in line with BDO policy, identifying deviations and notifying more senior team members in order to obtain appropriate approvals * Applying knowledge to identify instances where testing may be reduced or expanded and notifying more senior team members of the occurrence * Contributing ideas/opinions to the engagement teams Methodology: * Applies knowledge and application of BDO standards to guide effective and efficient delivery of quality services and products by: * Completing all appropriate documentation of BDO work papers * Ensuring assigned work is performed in accordance with BDO methodology and requirements Research: * Applies methodology used to seek or maintain information from authoritative sources and to draw conclusions regarding a target issue based on the information by: * Researching basic and intermediate accounting topics and forming an initial opinion on the treatment independently * Other duties as required: Supervisory Responsibilities: * N/A Qualifications, Knowledge, Skills and Abilities: Education: * Bachelor's degree in Accounting, Finance, Economics or Statistics, required OR Bachelor's degree in other focus area and CPA certification, required * Master's in Accountancy, preferred Experience: * One (1) or more years of prior relevant audit experience and/or public accounting, private industry accounting or consulting/professional services experience, required License/Certifications: * Eligible to sit for the CPA exams upon starting employment required and actively pursuing completion of the exams, required * CPA, preferred Software: * Proficient with the Microsoft Office Suite, preferred * Experience with assurance applications and research tools, preferred Language: * N/A Other Knowledge, Skills & Abilities: * Basic understanding and experience planning and coordinating the stages to perform an audit of a basic public and/or private company * Ability and willingness to travel, as needed * Knowledge of internal accounting controls and professional standards and regulations (GAAP, GAAS, Sarbanes-Oxley, etc) * Strong verbal and written communication skills with the ability to adapt style and messaging to effectively communicate with professionals at all levels both within the client organization and the firm * Ability to successfully multi-task while working independently and within a group environment * Solid analytical and diagnostic skills and ability to break down complex issues and implementing appropriate resolutions * Ability to of work in a demanding, deadline driven environment with a focus on details and accuracy * Solid project management skills Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography. California Range: $83,000 - $90,000 Colorado Range: $75,000 - $80,000 Illinois Range: $76,000 - $82,000 Maryland Range: $72,000 - $78,000 Minnesota Range: $70,000 - $74,000 NYC/Long Island/Westchester Range: $75,000 - $80,000 New Jersey Range: $76,500 - $83,000 Ohio Range: $70,000 - $78,000 Washington Range: $80,000 - $85,000

Stefanini Group is looking for Production Documentation Specialist - Irvine, CA This position is responsible for the generation/issuance of master batch record documentation, fulfillment of internal/external requests and housekeeping of active/archived department documents to support internal and external business requirements. · Generate, verify accuracy and issue master batch record documents including generation of LIMs record for drug product manufacturing and packaging based on the weekly production schedule, ensuring that all documentation required for each drug product batch is compiled prior to issuance to production for execution. · Daily monitor and update QA-issued SOP Binders used throughout the manufacturing site when new effective SOPs are issued, and perform routine audits of all TPM SOP Binders throughout the site. · Provide timely support and complete responses to QA documentation requests such as logbook issuance and reconciliation. · Maintain document master batch record files and QA archives, so they are appropriately filed, labeled, stored and readily accessible. · Maintain/update databases to ensure proper tracking of batch record issuance · Perform other duties as assigned, or as business needs require. Primary Outcomes · Completes accurate and timely review of all documentation listed above and ensures all Documentation is current, accurate and on schedule. · Works on assignments that are complex in nature, where ability to recognize deviation from accepted practice is required · Normally receives minimal instructions on routine work, and minimal instructions on new assignments Position Requirements: · Education Required: High School Diploma / GED · Education Preferred: AA Degree or some college · Experience Required: 3 years related experience · Experience Preferred: 4-6 years related experience · Specialized or Technical Knowledge Licenses, Certifications needed: N/A · Competencies: Please list five or six areas of competencies below that are necessary for the incumbent to do this position and that distinguish it from others similar to it Technical · Strong computer literate and experience using "Windows" computer software applications such as Word and Excel. Excellent oral and written communication. Ability to proofread · Experience with Business Applications such as Oracle, Electronic Document Management System, and LIMs is strongly preferred. · Experience with Scientific and/or Pharmaceutical terms is required. Planning & Organizational · Strong organization and time management is required · Able to work with the production schedule and plan accordingly as documentation is issued 10 business days in advance of scheduled run. · Able to adapt to changes in schedule and respond accordingly in order to issue current, effective documentation. · Ability to work in environment with interruptions/urgent requests and resume previous activities seamlessly. · Overtime/Off Shift On-site support may be required. · Interpersonal Excellent interpersonal skills are required as this position requires daily contact with our internal customers. Teamwork is essential as coordination between Documentation Control personnel is mandatory. Communication Proficient verbal communication skills are required as this position requires contact with our internal customers. Autonomy and Independence Preferred.

General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. We have an exciting opportunity for an Information Systems Security Officer (ISSO) to join our Classified Systems team in San Diego (Poway), CA. With general supervision, this position is responsible for participating in monitoring, evaluating and administering system compliance with information technology (IT) security requirements to ensure company, regulatory and customer requirements are met. DUTIES AND RESPONSIBILITIES: interprets regulations as they apply to information systems, platforms, and IT operating processes, practices and procedures. Participates in the development or modification of the computer environment information assurance security program plans and requirements. Participates in the development, distribution, and maintenance of System Security Plans, instructions, guidance, and standard operating procedures. Participates in audits of IT, platforms, and operating procedures; analyzes results. Participates in identifying risks and makes recommendations for improvements; may participate in corrective measures when incidents or vulnerabilities are discovered. Maintains knowledge of applicable policies, regulations, and compliance documents related to classified computing assets and environments. May represent the organization as a primary contact with internal representatives. Maintains the strict confidentiality of sensitive information. Performs other duties as assigned. Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Typically requires a bachelors degree in a related discipline and six or more years of progressive professional experience in information assurance or a related field. Equivalent professional experience may be substituted in lieu of education. Must possess an active Secret clearance and have the ability to obtain and maintain a TS (with SAP & SCI eligibility). Must maintain DoD 8570 IAM Level I (e.g. Security +) professional certification as required by customers or contractual obligations. Security + certification required. Experience with DoD policy such as Risk Management Framework and Joint SAP Implementation Guide. Operational experience with installing, troubleshooting, and auditing Windows desktop & server operating systems. Experience with DISA STIGs, SCAP tool, ACAS. Experience installing and troubleshooting common x86-based computer hardware. Must demonstrate a general understanding of information assurance principles, theories, concepts and techniques. Must have experience organizing, planning, scheduling, conducting, and coordinating work assignments to meet project milestones or established completion dates. Must possess the ability to understand new concepts quickly and apply them in an evolving environment while contributing to the development of new processes. Must be customer focused and possess: The ability to identify issues, analyze data and develop solutions to a variety of problems. Good analytical, verbal and written communication skills to accurately document, report, and present findings. Good interpersonal skills enabling an effective interface with other professionals; and good computer skills. Ability to work independently or in a team environment is essential as is the ability to work extended hours as required.

Job TitleQuality Assurance Coordinator About Us Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health. Find your future at Revvity Overview: BioLegend (a division of Revvity, Inc.) is seeking a highly motivated Quality Assurance Coordinator. The Quality Assurance Coordinator will be a multi-faceted and integral part of the Quality Assurance team and will perform and administer Quality Assurance (QA) activities at BioLegend, in accordance with BioLegend Vision, Mission, Quality Policy and Quality Objectives for implementation, maintenance and improvement of BioLegend's Quality Management System (QMS) and support the upcoming ERP system deployment. The QA Coordinator will be responsible for processing document control requests as well as assisting with the ongoing ERP project as needed, while supporting document control duties and training processes within current eQMS system (Smartsolve) as needed. Responsible for working with one or more of the following quality system processes: document control and training. Interacting with other QA departments and processes: change management, nonconformance, complaint management, CAPA management, supplier quality management, internal audits, post-market surveillance and vigilance management, risk management, QA product release and QA design control responsibilities. The QA Coordinator is responsible for ensuring quality systems procedures are followed and records are compliant in their applicable areas of responsibility. This role requires some work experience and knowledge of standards and regulations such as MDSAP, ISO 13485 and country and region-specific regulations (i.e. FDA 21 CFR 820, EU IVDD). Qualified individuals must also be proficient in computer word processing using Word and in other data analysis and presentations programs such as Excel, and PowerPoint. The QA Coordinator should possess strong organization skills and attention to detail and accuracy and they must be self-motivated, able to multi-task, and work effectively in a fast-paced environment; Good communication and interpersonal skills are essential in interactions with employees and others. The QA Coordinator must be a fast learner with the ability to quickly analyze and solve problems. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Acts in a support capacity for critical QMS processes such as, non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing, supplier Management and validation. Reviews quality records for all related areas of responsibility. Demonstrates the ability to work with limited direction and can prioritize projects independently Responsible for personal daily task management, training plans and performance management. Assist with generating, reviews and maintains QMS documents. Assist with monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and key performance indicators (KPIs). Assists with data preparation for Quality Management Reviews. Provides administrative support for external audits (regulatory or customer) and Internal Audits. Participates in the use of the eQMS system and expanded applications as appropriate. This position will interact with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain. Assist with monthly and management review data and metrics for areas of responsibility. Other projects or responsibilities as may be required. Basic Qualifications: Bachelors in a scientific discipline or equivalent work experience. A minimum of 0-1 work experience in quality assurance. Experience with GMP/GLP or similar regulated products. Experience in MS Word, Excel, Powerpoint, Adobe Acrobat (PDF) OR Associates Degree or equivalent work experience. A minimum of 2 years' work experience in quality assurance. Experience with GMP/GLP or similar regulated products. Experience in MS Word, Excel, Powerpoint, Adobe Acrobat (PDF) Preferred Experience: IVD, MDSAP, ISO 13485 or similar compliance experience Work Environment & Physical Demands Office While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear. The base salary range for this full-time position is $56,500.00 - $62,400.00. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered. #LI-JB1 What do we offer? We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits: Medical, Dental, and Vision Insurance Options Life and Disability Insurance Paid Time-Off Parental Benefits Compassionate Care Leave 401k with Company Match Employee Stock Purchase Plan Learn more about Revvity's benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page. *For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information. Revvity is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any characteristic or status protected by applicable federal, state, and/or local laws. If you are an applicant with a disability that requires reasonable accommodation to complete any part of the application process or are limited in the ability-or unable to use-the online application system and need an alternative method for applying, you may contact ********************.

Starting pay is $20.00 + per hour DOE Monday - Friday schedule A Shamrock Foods Quality Assurance Specialist is the voice of the customer and should always have the customers best interest in mind. The role encompasses but is not limited to, inspecting, and testing all produce to assure each product meets quality specifications when received into the warehouse, pick slots and all returned product from customers. The specialist will communicate daily with buyers in all aspects of produce including questionable product receiving, returns and slotting. Assists in ensuring the Shamrock Foods sales department has the very best produce available to ship to our customers and for the growth of the category. Essential Duties: * Daily inspections of the high volume produce products and most perishable produce for quality and ensure logical slot rotations. * Checks all incoming produce for quality, potential shelf life, sizing, USDA grade and acceptability of packaging. * Rejects any wrong or unacceptable products and reports all issues to buyers, Markon and Vendor Quality. * Serve as company liaison with Markon on all produce quality issues. * Communicates with produce purchasing on all incoming produce issues to jointly make a decision on the best course of action. * Daily slot checks in the warehouse with regard to produce are required for ensuring acceptable quality standards and proper follow through to have bad product dumped, working with produce re-pack to rework marginal product to be in a saleable condition, or sell through salvage. * Work with produce product returns to assure that only saleable products are returned to the pick slots. * Respond immediately to any quality challenges communicated from sales, customers, buyers or Shamrock inbound/outbound teams. * Other duties may be assigned. Qualifications: * High school diploma or general education degree (GED). * One plus year related work experience in various areas of the produce industry and/or training in produce quality inspections. * Demonstrates problem solving capabilities. * Demonstrates good communication skills. * Must be able to work in various temperature-controlled zones ranging from -5 F to ambient temperatures. * Must be flexible and willing to work the demands of the department which may be subject to evenings, weekends, and holidays. Corporate Summary: At Shamrock Foods Company, people come first - our associates, our customers, and the families we serve across the nation. A privately-held, family-owned and -operated Forbes 500 company, Shamrock is an innovator in the food industry and has been since being founded in Arizona in 1922. Our Mission: At Shamrock Foods Company, we live by our founding family's motto to "treat associates like family and customers like friends." Why work for us? Benefits are a major part of your overall compensation, and we believe offering them at an affordable cost is not only the right thing to do, but it helps keep you and your family healthy. That's why Shamrock Foods pays for the majority of your health insurance, allowing you to take home more of your paycheck. And it doesn't stop there - our associates also enjoy additional benefits such as 401(k) Savings Plan, Profit Sharing, Paid Time Off, as well as our incredible growth opportunities, continued education and wellness programs. Equal Opportunity Employer At Shamrock Foods Co all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status, sexual orientation, gender identity or any other basis protected by applicable law.

The QA Warehouse Associate is responsible for providing operational support to the Technical Inspector/Tire Warranty Technician. This position plays a key role in the handling, processing, and documentation of warranty tires and scrap materials, ensuring that all quality assurance and warehouse procedures are followed. Key Responsibilities: * Load and unload warranty tires using a forklift and/or by hand * Process scrap tires, including lumping and cutting as required * Move scrap tires to designated storage or disposal areas * Clean and maintain the QA C.A.P. Center to ensure a safe and organized work environment * Receive and stage inbound warranty adjustments for inspection and processing * Verify Bill of Lading (BOL) counts and update logs accurately * Assist in other quality assurance and warehouse activities as directed Qualifications: * Experience operating a forklift (certification preferred) * Ability to perform physically demanding tasks, including lifting and moving heavy items * Strong attention to detail and accuracy in recordkeeping * Commitment to safety protocols and procedures * Ability to work collaboratively in a team environment

Job DescriptionSalary: $25 - $30/hr Ready to Transform Your Career? Join SpiTrex 3D! Are you looking to be part of a dynamic team in the cutting-edge world of additive manufacturing? Do you thrive in a fast-paced, growing environment that blends high technology and USA manufacturing? If so, we have the perfect opportunity for you! We are a leading additive manufacturing company located in vibrant Carlsbad, California. Our innovative solutions are revolutionizing the industry, and we're seeking a talented Quality Assurance Associate to join our growing team. Imagine a workplace where your growth knows no bounds - where data drives success, and your career flourishes. We believe SpiTrex 3D is a workplace like no other. It is a place to be challenged, explore your curiosity, and grow your career. Job Overview: As a Quality Assurance Associate at SpiTrex 3D, you will play a crucial role in ensuring the highest standards of quality for our 3D printed products and services. Your focus will be on supporting and organizing critical Master Batch Records (MBRs) and Certificates of Conformances while supporting quality control activities such as with data entries (ERP System), lean manufacturing/scheduling, record archiving, documenting training records, and supporting change controls. Essential Functions: Company Culture and Mission: Consistently apply core values (Integrity, Impact, Dedication) to your decision-making process and interactions with others. Uphold and contribute to the companys quality policy commitment. Master Batch Records: Prepare master batch record job folders for new production builds Support and organize records and data entries to allow for approvals in a timely manner with an accurate compilation of product Master Batch Records, which include Certificates of Conformance. Assist in verifying manufacturing scheduling to ensure that all quality activities are occurring at or ahead of schedule. Using Microsoft Word, Excel, and JobBoss2 document and record data entries in cooperation with handwritten records. Review executed records for compliance, ensuring completeness of all necessary testing and documents across various processes as needed Quality Control Records: Archive, physical retains, printed records, and electronic records with scanning, filing, and sorting per quality standards. Ensure product processes adhere to established quality standards and guidelines. Support data collection and monitor data throughout the production process where needed. Defect Detection/nonconformances: Collaborate and support the identify and document defects, nonconformances, or deviations from quality standards. Work closely with quality leadership and production teams to address and resolve quality issues promptly. Support corrective actions to prevent recurrence of defects as needed. Training and Education: Stay updated on industry trends, quality standards, and regulations as needed. Support the maintenance of training records and training matrixes. Shipping Receiving: Assist with front office incoming receiving and outgoing shipments for both products and supplies. Assist in developing and performing quality checks and documentation for incoming materials. Communication Effectively communicate quality related information to supervisors, colleagues, and other relevant stakeholders. Compliance Comply with ISO 13485 Quality Management System, FDA 21 CFR Part 820 Quality System Requirements (QSR), and medical device industry requirements. Assist in the implementation of the quantity management system. Other work-related tasks as assigned. Competency: Understanding of quality control principles and inspection techniques. Strong understanding of GMPs and GDP for production and generation of batch records. Basic familiarity with mechanical testing and materials characterization. Excellent organizational skills. Basic ability to read and interpret engineering drawings and specifications. Problem-solving and troubleshooting skills. Organizational and time management skills. Very strong attention to detail. Strong commitment to safety and quality assurance. Effective communication and interpersonal skills to work with cross-functional teams. Education and Experience: Associate degree in related field and/or 18 months-4 years experience preferred. Experience in quality control in the medical device industry, aerospace, or automotive industry preferred. Experience with mechanical testing and materials characterization preferred. Benefits Include: Medical, Vision and Dental Insurance Short Term Disability 401(k) plus match Vacation days Paid holidays

As a Quality Assurance Associate, you will play a crucial role in ensuring the highest standards of quality for our 3D printed products and services. Your focus will be on supporting and organizing critical Master Batch Records (MBRs) and Certificates of Conformances while supporting quality control activities such as with data entries (ERP System), lean manufacturing/scheduling, record archiving, documenting training records, and supporting change controls. Essential Functions: * Company Culture and Mission: * Consistently apply core values (Integrity, Impact, Dedication) to your decision-making process and interactions with others. * Uphold and contribute to the company's quality policy commitment. * Master Batch Records: * Prepare master batch record job folders for new production builds * Support and organize records and data entries to allow for approvals in a timely manner with an accurate compilation of product Master Batch Records, which include Certificates of Conformance. * Assist in verifying manufacturing scheduling to ensure that all quality activities are occurring at or ahead of schedule. * Using Microsoft Word, Excel, and JobBoss2 document and record data entries in cooperation with handwritten records. * Review executed records for compliance, ensuring completeness of all necessary testing and documents across various processes as needed * Quality Control Records: * Archive, physical retains, printed records, and electronic records with scanning, filing, and sorting per quality standards. * Ensure product processes adhere to established quality standards and guidelines. * Support data collection and monitor data throughout the production process where needed. * Defect Detection/nonconformances: * Collaborate and support the identify and document defects, nonconformance's, or deviations from quality standards. * Work closely with quality leadership and production teams to address and resolve quality issues promptly. * Support corrective actions to prevent recurrence of defects as needed. * Training and Education: * Stay updated on industry trends, quality standards, and regulations as needed. * Support the maintenance of training records and training matrixes. * Shipping Receiving: * Assist with front office incoming receiving and outgoing shipments for both products and supplies. * Assist in developing and performing quality checks and documentation for incoming materials. * Communication * Effectively communicate quality related information to supervisors, colleagues, and other relevant stakeholders. * Compliance * Comply with ISO 13485 Quality Management System, FDA 21 CFR Part 820 Quality System Requirements (QSR), and medical device industry requirements. * Assist in the implementation of the quantity management system. * Other work-related tasks as assigned. Competency: * Understanding of quality control principles and inspection techniques. * Strong understanding of GMPs and GDP for production and generation of batch records. * Basic familiarity with mechanical testing and materials characterization. * Excellent organizational skills. * Basic ability to read and interpret engineering drawings and specifications. * Problem-solving and troubleshooting skills. * Organizational and time management skills. * Very strong attention to detail. * Strong commitment to safety and quality assurance. * Effective communication and interpersonal skills to work with cross-functional teams. Education and Experience: * Associate degree in related field and/or 18 months-4 years' experience preferred. * Experience in quality control in the medical device industry, aerospace, or automotive industry preferred. * Experience with mechanical testing and materials characterization preferred. Job Type & Location This is a Contract to Hire position based out of Carlsbad, CA. Pay and Benefits The pay range for this position is $25.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Carlsbad,CA. Application Deadline This position is anticipated to close on Jan 6, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Starting pay is $20.00 + per hour DOE Monday - Friday schedule A Shamrock Foods Quality Assurance Specialist is the voice of the customer and should always have the customers best interest in mind. The role encompasses but is not limited to, inspecting, and testing all produce to assure each product meets quality specifications when received into the warehouse, pick slots and all returned product from customers. The specialist will communicate daily with buyers in all aspects of produce including questionable product receiving, returns and slotting. Assists in ensuring the Shamrock Foods sales department has the very best produce available to ship to our customers and for the growth of the category. Essential Duties: Daily inspections of the high volume produce products and most perishable produce for quality and ensure logical slot rotations. Checks all incoming produce for quality, potential shelf life, sizing, USDA grade and acceptability of packaging. Rejects any wrong or unacceptable products and reports all issues to buyers, Markon and Vendor Quality. Serve as company liaison with Markon on all produce quality issues. Communicates with produce purchasing on all incoming produce issues to jointly make a decision on the best course of action. Daily slot checks in the warehouse with regard to produce are required for ensuring acceptable quality standards and proper follow through to have bad product dumped, working with produce re-pack to rework marginal product to be in a saleable condition, or sell through salvage. Work with produce product returns to assure that only saleable products are returned to the pick slots. Respond immediately to any quality challenges communicated from sales, customers, buyers or Shamrock inbound/outbound teams. Other duties may be assigned. Qualifications: High school diploma or general education degree (GED). One plus year related work experience in various areas of the produce industry and/or training in produce quality inspections. Demonstrates problem solving capabilities. Demonstrates good communication skills. Must be able to work in various temperature-controlled zones ranging from -5 F to ambient temperatures. Must be flexible and willing to work the demands of the department which may be subject to evenings, weekends, and holidays. Corporate Summary: At Shamrock Foods Company, people come first - our associates, our customers, and the families we serve across the nation. A privately-held, family-owned and -operated Forbes 500 company, Shamrock is an innovator in the food industry and has been since being founded in Arizona in 1922. Our Mission: At Shamrock Foods Company, we live by our founding family's motto to “treat associates like family and customers like friends.” Why work for us? Benefits are a major part of your overall compensation, and we believe offering them at an affordable cost is not only the right thing to do, but it helps keep you and your family healthy. That's why Shamrock Foods pays for the majority of your health insurance, allowing you to take home more of your paycheck. And it doesn't stop there - our associates also enjoy additional benefits such as 401(k) Savings Plan, Profit Sharing, Paid Time Off, as well as our incredible growth opportunities, continued education and wellness programs. Equal Opportunity Employer At Shamrock Foods Co all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status, sexual orientation, gender identity or any other basis protected by applicable law.

The Assurance Experienced Associate will be responsible for preparing financial statements with disclosures, applying basic areas of GAAP as necessary and documenting, validating, testing, and assessing various control systems. This position may also be involved in reviews and agreed-upon procedure engagements. Job Duties: Control Environment: Applies knowledge and understanding of the collective effect of various factors on establishing or enhancing effectiveness, or mitigating the risks, of specific policies and procedures by: Identifying and considering all applicable policies, laws, rules, and regulations of the firm, regulators, or other authoritative bodies as part of engagement team Making constructive suggestions to improve client internal controls and accounting procedures Documenting and validating the operating effectiveness of the clients' internal control system GAAP: Applies knowledge and understanding of governing principles; applying these principles to client transactions; and documenting and communicating an understanding and application of these principles by: Providing support of conclusions with authoritative literature Drafting basic sets of financial statements with disclosures Researching intermediate areas of accounting and forming an initial opinion on the correct treatment independently GAAS: Applies knowledge and understanding of professional standards; application of the principles contained in professional standards; and the ability to document and communicate an understanding and application of professional standards on an engagement by: Developing and applying an intermediate knowledge of auditing theory, a sense of audit skepticism, and the use of BDO audit manuals Applying auditing theory to various client situations Documenting in line with BDO policy, identifying deviations and notifying more senior team members in order to obtain appropriate approvals Applying knowledge to identify instances where testing may be reduced or expanded and notifying more senior team members of the occurrence Contributing ideas/opinions to the engagement teams Methodology: Applies knowledge and application of BDO standards to guide effective and efficient delivery of quality services and products by: Completing all appropriate documentation of BDO work papers Ensuring assigned work is performed in accordance with BDO methodology and requirements Research: Applies methodology used to seek or maintain information from authoritative sources and to draw conclusions regarding a target issue based on the information by: Researching basic and intermediate accounting topics and forming an initial opinion on the treatment independently Other duties as required: Supervisory Responsibilities: N/A Qualifications, Knowledge, Skills and Abilities: Education: Bachelor's degree in Accounting, Finance, Economics or Statistics, required OR Bachelor's degree in other focus area and CPA certification, required Master's in Accountancy, preferred Experience: One (1) or more years of prior relevant audit experience and/or public accounting, private industry accounting or consulting/professional services experience, required License/Certifications: Eligible to sit for the CPA exams upon starting employment required and actively pursuing completion of the exams, required CPA, preferred Software: Proficient with the Microsoft Office Suite, preferred Experience with assurance applications and research tools, preferred Language: N/A Other Knowledge, Skills & Abilities: Basic understanding and experience planning and coordinating the stages to perform an audit of a basic public and/or private company Ability and willingness to travel, as needed Knowledge of internal accounting controls and professional standards and regulations (GAAP, GAAS, Sarbanes-Oxley, etc) Strong verbal and written communication skills with the ability to adapt style and messaging to effectively communicate with professionals at all levels both within the client organization and the firm Ability to successfully multi-task while working independently and within a group environment Solid analytical and diagnostic skills and ability to break down complex issues and implementing appropriate resolutions Ability to of work in a demanding, deadline driven environment with a focus on details and accuracy Solid project management skills Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography. California Range: $83,000 - $90,000 Colorado Range: $75,000 - $80,000 Illinois Range: $76,000 - $82,000 Maryland Range: $72,000 - $78,000 Minnesota Range: $70,000 - $74,000 NYC/Long Island/Westchester Range: $75,000 - $80,000 New Jersey Range: $76,500 - $83,000 Ohio Range: $70,000 - $78,000 Washington Range: $80,000 - $85,000

Job Title: QA AssociateJob Description Are you looking to be part of a dynamic team in the cutting-edge world of additive manufacturing? Do you thrive in a fast-paced, growing environment that blends high technology and USA manufacturing? If so, we have the perfect opportunity for you! As a Quality Assurance Associate, you will play a crucial role in ensuring the highest standards of quality for our 3D printed products and services. Your focus will be on supporting and organizing critical Master Batch Records and Certificates of Conformances while supporting quality control activities. Responsibilities * Consistently apply core values such as Integrity, Impact, and Dedication to decision-making processes and interactions with others. * Uphold and contribute to the company's quality policy commitment. * Prepare master batch record job folders for new production builds. * Support and organize records and data entries for timely approvals and accurate compilation of product Master Batch Records. * Assist in verifying manufacturing scheduling to ensure quality activities occur as scheduled. * Document and record data entries using ERP System, Excel, and JobBoss2 in cooperation with handwritten records. * Review executed records for compliance, ensuring completeness of all necessary testing and documents. * Archive physical retains, printed records, and electronic records, ensuring adherence to quality standards. * Collaborate to identify and document defects, nonconformances, or deviations from quality standards. * Work closely with quality leadership and production teams to address and resolve quality issues promptly. * Support corrective actions to prevent recurrence of defects. * Stay updated on industry trends, quality standards, and regulations. * Support the maintenance of training records and training matrices. * Assist with incoming receiving and outgoing shipments for both products and supplies. * Develop and perform quality checks and documentation for incoming materials. * Effectively communicate quality-related information to supervisors, colleagues, and other stakeholders. * Comply with ISO Quality Management System, FDA 21 CFR Part 820 Quality System Requirements, and medical device industry requirements. * Assist in the implementation of the quality management system. Essential Skills * Understanding of quality control principles and inspection techniques. * Strong understanding of GMPs and GDP for production and generation of batch records. * Basic familiarity with mechanical testing and materials characterization. * Excellent organizational skills. * Ability to read and interpret engineering drawings and specifications. * Problem-solving and troubleshooting skills. * Organizational and time management skills. * Strong attention to detail. * Commitment to safety and quality assurance. * Effective communication and interpersonal skills to work with cross-functional teams. Additional Skills & Qualifications * Associate degree in a related field and/or 18 months-4 years' experience preferred. * Experience in quality control in the medical device industry, aerospace, or automotive industry preferred. * Experience with mechanical testing and materials characterization preferred. Work Environment The position is onsite and full-time in Carlsbad, California. Our innovative solutions are revolutionizing the industry, offering a unique workplace where your growth knows no bounds. This is a place to be challenged, explore your curiosity, and grow your career. Job Type & Location This is a Contract to Hire position based out of Carlsbad, CA. Pay and Benefits The pay range for this position is $25.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Carlsbad,CA. Application Deadline This position is anticipated to close on Jan 14, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.