Quality assurance specialist jobs in San Marcos, CA - 261 jobs

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others The Director, Quality Assurance (GCP) oversees the development, implementation, maintenance, and performance of GCP Quality Assurance systems both within company and external vendors. The Director will execute and/or ensure proper oversight of the GCP QA audit program management, clinical operations phase 1 to phase 4 study team support, regulatory inspections, and GCP QA infrastructure development.**ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:**These may include but are not limited to:General* Provide GCP quality assurance strategy and oversight of QA GCP operations* Ensures that clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies* Develop and implement risk management strategies to identify, assess, and mitigate risks* Drive effective initiatives that foster a culture of quality and continuous improvement* Successfully collaborate on multiple projects with cross-functional stakeholders* Lead investigations of significant complexity* Prepare and present to executive management* Manage, lead, and mentor quality assurance team members; lead cross-functional teams on compliance projects Audit Management* Develop a plan with CROs for clinical sites' audit execution* Manage clinical site, TMF, and GCP and GLP vendor audit activities* Generate and/or review and approve overall GCP QA audit plans and schedules* Generate and/or review and approve audit trend reports* Execute the GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends Study Team Support & Issue Escalation Management* Represent QA at program-wide (e.g., study team or governance) meetings and provide GCP guidance and feedback* Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads, and responsible for informing the head of QA and Management, as required* Manage quality events, CAPAs, and deviations* Collaborate with cross-functional teams (Clinical Operations, Clinical Research, Regulatory, etc.) to embed quality by design in clinical programs.* Provide guidance and support to Trial Master File activities Quality Systems / Inspections / Infrastructure* Ensure adequate systems and controls are in place for GCP compliance* Identify and address quality systems gaps, including internal processes and personnel GCP training* Execute the review of GCP SOP tracking and status reports to ensure timely review and development of SOPs* Author, review, or revise SOPs related to clinical and non-clinical studies* Develop and provide GCP training* Support regulatory inspection activities* and GCP inspection readiness activities* Prepare internal team, clinical sites, and vendors for inspection readiness* Thoroughly review clinical study documents* Perform breach assessments* Oversee quality vendor management and governance for GCP and GLP vendors* Review Quality Agreements to ensure clear delineation of responsibilities and compliance expectations between the sponsor and the vendor* Contribute and present GCP quality events and metrics at the Quality Management Review meeting* Support other Quality Assurance and Quality Systems activities* Other duties as assigned.**Education and Experience**Required:* Minimum Bachelor's degree in a science discipline and at least 12 years' experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered)* Minimum of 8 years of working in a GCP QA function* Previous experience leading inspection readiness and audits* Thorough understanding of FDA, EU and local regulations, as well as understanding of ICH guidelines* Hands-on experience in developing and implementing GCP procedures* Strong working knowledge of GCP and GLP regulations* Proven ability to cultivate and develop relationships with cross functional teams and vendors* Demonstrated leadership ability to identify, manage and develop QA teams* Must be able to make critical and strategic decisions based on risk-assessments* Capable of managing multiple projects simultaneously* Excellent communication and listening skills Preferred:* Auditing certification is a plus**Physical Demands and Work Environment:**Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.**Travel:**You may be required to travel for up to 10% of your time.**The Anticipated Base Salary Range: $1****76,000 - $220,000***In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.*The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.**Equal Opportunity Employer:**Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.**Vaccination requirement:**Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone #J-18808-Ljbffr

About the job Type: Full-Time, Direct Hire NCC Talent Solutions is proud to partner with a growing CDMO biotech startup in San Diego to identify a Head of Quality who will play a critical leadership role in building, scaling, and safeguarding the company's Quality function during an exciting phase of growth. This is a high-impact opportunity for a quality leader who enjoys rolling up their sleeves, setting standards, and serving as a strategic partner to the business while ensuring compliance with global regulatory expectations. About the Role As the Head of Quality, you will lead the Quality Assurance organization and serve as the primary QA representative across internal teams and external partners. You will be responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) in alignment with FDA, EMA, and ICH GMP regulations, while supporting regulatory inspections, customer audits, and submissions. Beyond compliance, this role is instrumental in driving operational excellence-reducing waste, improving efficiency, and embedding quality as a core business enabler as the organization scales. Key Responsibilities: Leadership & Strategy Lead, mentor, and develop the Quality Assurance team. Serve as the QA representative for assigned programs at the management and external stakeholder level. Oversee all QA programs and projects, ensuring cross-functional alignment and on-time execution. Provide leadership in the design and continuous improvement of QA processes, systems, tools, and organizational structures. Quality Systems & Compliance Establish, implement, and maintain a robust Quality Assurance System. Ensure internal documentation and processes comply with applicable regulatory requirements. Translate evolving regulatory expectations into practical internal quality standards. Independently monitor and assess the effectiveness of the QMS. Operational Quality Oversight Partner closely with internal departments and external service providers to uphold quality policy. Own and manage the company's documentation control system, including creation, review, approval, and maintenance of GMP documentation. Lead deviation management, CAPAs, and change control processes. Support and participate in internal audits, customer audits, regulatory inspections, and contractor audits. Review and approve qualification and validation plans and batch releases. Process Ownership & Continuous Improvement Act as process owner for assigned quality processes, including: Regular review and optimization of processes Ensuring appropriate training and readiness of impacted employees Staying current on regulatory trends, guidance, and industry best practices Serving as the primary point of contact during audits and inspections Desired Qualifications Education Bachelor's degree (or higher) in Pharmacy, Biotechnology, Natural Sciences, Engineering, or a related field, or equivalent professional experience. Experience & Expertise Minimum of 5 years of experience in Quality Assurance in a GMP-regulated environment, preferably with experience with aseptic processing. Strong working knowledge of bioprocessing, manufacturing, and analytical operations. Demonstrated leadership or people-management experience. Experience supporting regulatory inspections and audits. Skills Strong written and verbal communication skills in English. Ability to balance strategic thinking with hands-on execution in a fast-paced, growth-stage environment. Why This Role This is a rare opportunity to shape the Quality function from the ground up within a growing CDMO, with direct influence on compliance, culture, and long-term success. The Head of Quality will be a trusted leader and partner to the business, with visibility, autonomy, and the ability to make a lasting impact. NCC Talent Solutions is managing this search on behalf of our client. All inquiries and applications will be handled with discretion.

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.

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 Create accurate Bill of Materials and assembly drawings for our ERP system that informs the Manufacturing and Assembly teams what to fabricate and how to assemble the product. This is a full-time position, and hours of work and days are varied. Ability to work Monday through Friday (6:30 A.M - 3:30 P.M., 7A.M -4P.M.) Occasional evening and weekend work may be required as job duties demand. Key Tasks & Responsibilities (Essential Functions) * Interpret and create drawings for simple to complex product and assembly drawings in order to make accurate BOMs. * Creation of BOMs and drawings for individual parts, sub-assemblies and finished products. * Modify/Update existing BOMs to meet the needs of new specific requirements. * Develop drawings for new custom parts needed in the BOMs. * Work collaboratively with Engineering and Design Assist Departments. * Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Experience (minimum experience required) * Proficient knowledge working in Windows environment and software related (Outlook, Office, etc.). * Knowledge of engineering Solid works software. * Knowledge and understanding of the concept of Bills of Materials and how they are built. * Ability to learn new software and processes. * Ability to read and interpret drawings and diagrams. * Ability or willingness to learn how to analyze parts, assemblies, and production processes. * High capacity to work in a focused and methodical manner. * High capacity to work under pressure and fulfill tight deliver schedules. * Comfortable working on highly focused tasks. Computer program knowledge should include the following, but training is available for the right candidate: * MS Office (excel, PowerPoint, Word), SharePoint * SolidWorks * Adobe Illustrator & Photoshop (preferred but not essential) Education * Minimum - High School Diploma with 1-2 years of drafting technician experience. * College or Associate Degree manufacturing or drafting technical education preferred. Preferred Experience (i.e., industry experience) Highly proficient in the use of PC and software related to engineering: * 3D modeling * 2D technical drawing * Data base drawing management * The candidate must be a fast learner with excellent retention of knowledge and details Physical Requirements * Light Work Work Environment * This position is within a professional work environment. * This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. * The employee is exposed to a variety of extreme conditions that may be found while walking the production floor. * No travel will be required for this position. #LI-EG1 The range for this position is $36,000 to $64,800. Placement within this range may vary, depending on the applicant's experience and geographic location. Acuity offers generous benefits including health care, dental coverage, vision plans, 401K benefits, and commissions/incentive compensation depending on the role. For a list of our benefits, click here. We value diversity and are an equal opportunity employer. All qualified applicants will be considered for employment without regards to race, color, age, gender, sexual orientation, gender identity and expression, ethnicity or national origin, disability, pregnancy, religion, covered veteran status, protected genetic information, or any other characteristic protected by law. Please click here and here for more information. Accommodation for Applicants with Disabilities: As an equal opportunity employer, Acuity Inc. is committed to providing reasonable accommodations in its application process for qualified individuals with disabilities and disabled veterans. If you have difficulty using our online system due to a disability and need an accommodation, you may contact us at **************. Please clearly indicate what type of accommodation you are requesting and for what requisition. Any unsolicited resumes sent to Acuity Inc. from a third party, such as an Agency recruiter, including unsolicited resumes sent to an Acuity Inc. mailing address, fax machine or email address, directly to Acuity Inc. employees, or to Acuity Inc. resume database will be considered Acuity Inc. property. Acuity Inc. will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Acuity Inc. will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor, but does not have the appropriate approvals to be engaged on a search. E-Verify Participation Poster e-verify.gov eeoc.gov Nearest Major Market: San Diego Job Segment: Drafting, Machinist, Sharepoint, Developer, ERP, Engineering, Manufacturing, Technology

JOB TITLE: Quality Assurance Manager PAY RATE: $75/hour We are a national aerospace and defense staffing agency seeking highly qualified candidates for a position with a top-tier client. Job Details: Job Type: Contract (12 months with potential for extension) Industry: Aerospace / Defense / Aviation Benefits: Medical, dental, and vision (Cigna) Perks: Bonus potential + Priority access via Tier 1 supplier Openings Nationwide: Thousands of opportunities across the U.S. Qualifying Questions: Are you a U.S. person as defined under ITAR regulations? Do you meet the educational and experience requirements for this role? Can you commute to the job location or relocate if necessary? Summary: Regulatory compliance (FAA, AS9100, DCMA) Leadership and development of quality teams Oversight of inspection, documentation, and airworthiness activities Continuous improvement and audit readiness Requirements: Minimum of 7 years of related experience within a 14 CFR Part 145 Repair Station, with exposure to 14 CFR Part 21 PAH or AS9100 aerospace manufacturing environments At least 5 years of leadership experience managing and developing teams Bachelor's or Associate's degree in a related field preferred FAA Airframe and/or Powerplant (A&P) license required FAA Inspector Authorization (IA) strongly preferred Strong working knowledge of Federal Aviation Regulations, airworthiness directives, and approved maintenance and alteration data Demonstrated ability to provide direction while collaborating effectively with management teams Experience with DCMA flight and ground operations compliance preferred Proven ability to lead and manage a team of quality professionals in a goal-driven environment Ability to read and interpret technical data, repair manuals, and engineering drawings In-depth knowledge of FAA regulations, including 14 CFR Parts 21, 43, 65, 91, and 145 Experience researching and interpreting aircraft historical records and logbooks Excellent verbal and written communication skills Strong work ethic with a high level of organization and attention to detail Must be a U.S. Citizen (as defined by ITAR). About Us: The Structures Company is a premier national aerospace and defense staffing agency specializing in contract, contract-to-hire, and direct hire placements. We deliver expert workforce solutions across engineering, IT, production, maintenance, and support roles. As trusted partners to major aerospace OEMs and Tier 1 suppliers, we connect professionals with opportunities to grow and excel in the aviation and aerospace industries. Eligibility Requirements: Must be a U.S. Citizen, lawful permanent resident, or protected individual under 8 U.S.C. 1324b(a)(3) to comply with ITAR regulations. Keywords: aerospace, aviation, engineering, maintenance, aircraft design, defense Take your career to new heights-apply today!

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.

Are you driven by quality, detail, and making sure issues are resolved the right way the first time? Hologic is seeking a Quality Supply Assurance Specialist II to support our business operations by ensuring timely resolution of quality issues while maintaining full compliance for non-conformances and associated quality records. In this role, you'll work cross-functionally to support MRB and product quality forums, guide investigations, and contribute to continuous improvement across our Quality Management System. If you enjoy working in a highly detailed, regulated environment and want to help ensure safe, reliable products reach our customers, this role is for you. Knowledge Working knowledge of FDA Quality System Regulations and ISO 13485. Familiarity with risk management concepts and quality workflows related to non-conformances, corrections, and corrective actions. Understanding of Quality Systems elements such as Material Review Board (MRB), Product Quality Committee (PQC), and quality metrics. Knowledge of ERP-based quality transactions and basic quality data reporting. Skills Ability to review and assess non-conformance, correction, and corrective action records for accuracy, completeness, and appropriateness. Strong facilitation skills to support and coordinate cross-functional meetings (MRB, PQC, Product Response Team). Proficiency in Microsoft Word, Excel (including graphing and data presentation), and related office tools. Experience working in ERP systems (strongly preferred). Excellent oral and written communication skills, including clear technical writing for quality records and SOP support. Ability to support investigations using quality workflows, trend queries, and other analytical tools. Strong organizational and multitasking skills in a detail-oriented, regulated environment. Behaviors Self-starter who works effectively with minimal supervision. Detail-focused and diligent in maintaining compliant, accurate quality records. Collaborative team member who enjoys partnering across departments and acting as a QA interface. Continuous improvement mindset, actively contributing ideas to improve processes and quality system performance. Accountable and reliable, ensuring timeliness in deliverables and follow-through on quality commitments. Experience BA/BS degree required, or equivalent experience/certification. 2+ years of experience in Quality, with strong emphasis on Quality Systems and non-conformances. Experience in an FDA-regulated environment is required. Experience supporting external audits and regulatory body inspections is beneficial. ASQ Certification (CQA, CQE) preferred. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $65,900- $103,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-NT1

General Atomics (GA), and its affiliated companies, is one of the world's leading resources for high-technology systems development ranging from the nuclear fuel cycle to remotely piloted aircraft, airborne sensors, and advanced electric, electronic, wireless and laser technologies. We have an exciting opportunity for an ISSO to join our Security Classified Systems team. This position is located in San Diego (Rancho Bernardo) CA. 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 be able to meet the requirements to obtain and maintain a Department of Energy (DOE) Q clearance 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 focus 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.

Veteran Firm Seeking a Software Documentation Specialist for an Onsite Assignment in San Diego, CA My name is Stephen Hrutka, and I lead a Veteran-owned consulting firm in Washington, DC, focused on strategic sourcing, supply chain, and IT Staffing. We are seeking to fill the Software Documentation Specialist role for an innovative rail engineering solutions provider and systems integrator company. The ideal candidate is a San Diego resident with 4-6 years of experience in technical documentation, and proficiency with document management tools. If you're interested, I'll gladly provide more details about the role and further discuss your qualifications. Thanks, Stephen M Hrutka Principal Consultant *************** Executive Summary: HRUCKUS is looking for an experienced Software Documentation Specialist to support a client's technical delivery and services teams by creating, managing, and maintaining all technical documentation for their software products. Essential Job Functions/Responsibilities: * Developing user manuals, technical specifications, test plans and online help content to ensure clarity and accessibility * Organization and maintain company's documents, including cataloging * Collaboration with engineers, product managers and other team members to gather information and ensure accuracy * Manage documentation projects from inception to completion, including planning, scheduling, and tracking progress to meet deadlines * Proactively identifies documentation needs, proposes improvements, and takes ownership of content creation and maintenance processes. Position Requirements: * Bachelor's degree in Technical Communication, or a related field * 4-6 years of experience in creating technical documentation, including test plans and software development guides. * Ability to communicate clearly, both orally and in writing * Strong organizational skills * Proficiency in document management tools Position Details: * This is an onsite role in San Diego, CA. * This position will report primarily to a Sr. Director of Engineering and interface with multiple managers across technical delivery and services teams. * Salary range is from $82,000 to $85,000 annually.

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 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 ********************.

ADARx is seeking a qualified and highly motivated individual at the QA Associate III level to join the Quality Assurance (QA) group. This is a key role within the QA group and offers exciting opportunity for the successful candidate to make major contributions to the development, implementation and maintenance of the Quality Management System (QMS) at ADARx. This role will collaborate closely with CMC and Clinical functions at ADARx to ensure that quality practices, procedures, standards and systems are established and followed to maintain compliance to applicable cGxP regulations. Essential Responsibilities: * Assist in the development, implementation, improvement and maintenance of ADARx's overall Quality Management System (QMS). * Support the implementation of an electronic Quality Management System (eQMS) and act as the administrator to ensure proper configuration and usage of the system. Provide training and support to eQMS users. * Provide QA support and oversight to internal staff and suppliers to ensure compliance with SOPs and relevant cGxP requirements. * Manage the Document Control process for creating or revising controlled documents following internal procedures. * Manage the training program and ensure all GxP related personnel receive appropriate training. Maintain and update training files and training curricula. * Support the development of QA-related training materials and provide QA process training to new and existing employees. * Author, review, and approve Quality System records, including deviation, CAPA, change records, etc. * Author, review, and approve controlled documents for QA and other functional areas. * Conduct and support supplier qualification activities, including issuance and review of quality questionnaires, supplier audits, and review of quality agreements. * Manage supplier files and the approved supplier list to ensure they are accurate and up-to-date. * Support internal audits, including planning, risk assessment, scope, audit program development, fieldwork, reporting and action follow-up. * Collect and summarize Key Quality Indicator (KQI) metrics for review to identify trends. * Support the preparation and hosting of regulatory inspections and external audits. * Proactively identify gaps/risks and propose solutions to support continuous improvement. Essential Physical Characteristics: Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: * BS/MS degree in a related scientific or technical discipline * 6+ years of experience in the biotech/pharmaceutical industry * 4+ years of experience in the QA function in a cGxP environment * Strong understanding of cGMP and ICH regulations and guidance * Demonstrated experience in development and implementation of quality processes, procedures and systems * Prior experience using an eQMS is required Preferred Qualifications * Previous experience in a GMP QC lab or manufacturing environment preferred * GCP experience a plus * Experience in implementation and/or administration of an eQMS is a plus Required Key Attributes: * Must be able to work independently with supervision as needed. * Must be collaborative, work well with other team members in a matrix team environment. * Excellent written and verbal communication skills are essential for this role. * Strong organizational skills with attention to detail and accuracy. * Ability to maintain a high level of confidentiality and exercise discretion. * Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges. * Understand project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders. Compensation: * This is a full-time position, Monday-Friday. * Pay is commensurate with experience. * Equity-based compensation * Performance-based bonuses * 401(k) with Company Match * Medical, Dental, Vision * Flexible Spending Account * Life Insurance * Employee Assistance Program * Employee Discounts * Gym Membership * Paid Vacation * Paid Holidays * Paid Sick, Jury Duty, Bereavement Work Authorization: * United States (Required) * Background Check * As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the "Company" or "ADARx") located in San Diego, is a late-clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of highly regarded investors. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement * The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. * Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. * The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law. * Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses. * Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Required Skills: - Bachelor's degree in Technical Communication, or a related field - 4-6 years of experience in creating technical documentation, including test plans and software development guides. - Ability to communicate clearly, both orally and in writing - Strong organizational skills - Proficiency in document management tools

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, this opportunity is perfect 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 (MBRs) and Certificates of Conformances while supporting quality control activities, including data entries, lean manufacturing/scheduling, record archiving, documenting training records, and supporting change controls. Responsibilities * Consistently apply core values (Integrity, Impact, 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 to allow for timely approvals with an accurate compilation of product Master Batch Records, including Certificates of Conformance. * Assist in verifying manufacturing scheduling to ensure all quality activities occur on or ahead of schedule. * Document and record data entries using software tools in cooperation with handwritten records. * Review executed records for compliance, ensuring completeness of all necessary testing and documents across various processes as needed. * Archive, retain, and sort printed and electronic records per quality standards. * Ensure product processes adhere to established quality standards and guidelines. * 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 as needed. * Support the maintenance of training records and training matrices. * 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. * Effectively communicate quality-related information to supervisors, colleagues, and other relevant stakeholders. * Comply with ISO Quality Management System, FDA 21 CFR Part 820 Quality System Requirements (QSR), and medical device industry requirements. * Assist in the implementation of the quality management system. Essential Skills * 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. Additional Skills & Qualifications * Hands-on experience with batch record review and Good Documentation Practices. * QC data review and review of SOPs and controlled documents. * 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 Onsite, full-time position located in vibrant Carlsbad, California. Our innovative solutions are revolutionizing the industry, offering a workplace where data drives success and your career flourishes. 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 23, 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.

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

Description: Job Title: Digital Specialist I Reports To: Digital Manager or Digital Supervisor Summary: This position is responsible for accurately preparing and scanning a high volume of data to convert printed material into digital images within a reasonable proximity to department hourly average. Essential Functions Responsible for preparing and scanning paper documents according to customer specifications and directions. Accepting changes to those specifications and directions understanding customer needs may change. Utilize the automatic feeder and flatbed scanner to scan a variety of paper sizes. Set scanner parameters as identified for each job to ensure accurate handling per customer specifications. Responsible for daily maintenance/cleaning of scanner to ensure image quality. Responsible for logging document/box numbers assigned during scanning for future retrieval. Assist other team members with document preparation and indexing. Complete all other tasks assigned by supervisor or Director of Operations. Requirements: Competencies: Detailed knowledge of the digital scanning process including an understanding of how digital scanners work. Ability to locate and select appropriate client files in the computer system for scanning into the appropriate location. Able and willing to consistently report to work on time prepared to perform duties of position. Understanding of the need to set and meet departmental productivity benchmarks and quality standards. Well organized and detail oriented. Able to work both on a team and individually. Compensation is $18/hr. with $0.50 night shift differential. Work Environment: Must be able to tolerate heat in the summer and cold in the winter. Physical Demands: While performing the duties of this job, the employee is regularly required to stand and walk. The employee is occasionally required to sit, climb/balance, stoop, kneel, or crouch. Must be able to reach, handle, carry, and lift between 10 lbs. and up to 50 lbs. While performing job duties, the employee is regularly required to talk, hear, read, and identify numbers for accurate order filling and receiving of material. Education and Eligibility Requirements Must be able and willing to communicate effectively in English. Must have skill and proficiency using a computer workstation and scanner systems. Ability to trouble-shoot computer problems as they relate to electronic document conversion. Must be able and willing to work overtime hours as needed. Must have a positive and respectful attitude towards both coworkers and customers. Must be able and willing to follow Company policies and procedures. Other duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the applicant for this job. Activities, duties, and responsibilities may change at any time with or without notice. VRC is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate based on race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, disability, veteran status, marital status, or any other legally protected status. All qualified applicants will receive equal consideration for employment.

Cirsium Biosciences is creating the next generation of manufacturing technologies for viral vector production. Our novel plant-based platform solves the existing problems of speed, flexibility, scalability, and safety in viral vector manufacturing while dramatically reducing production costs. Our goal is to enable global and equitable access to life-changing genetic therapies. Position Overview We are seeking a highly collaborative Director, Quality Assurance to join and lead the QA function for our growing organization. This strategic role will oversee all aspects of Quality, including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. Our ideal candidate should have a strong knowledge of relevant regulations and be able to manage and work cross‑functionally to ensure compliance of Cirsium's ongoing development programs with local, state and federal requirements. This position will support developing a culture of quality, ensuring compliance with regulatory requirements, driving continuous improvement in quality systems, supporting the successful development, manufacturing, and commercialization of our unique products. Key responsibilities Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues. Work with the company's external suppliers and contract organizations to ensure consistent quality and compliance. Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding Work on qualification and validation plans, assure proper batch releases and disposition. Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA). Provide quality input on contracts and serve as a point person for negotiations of quality agreements. Champion a culture of quality and continuous improvement across manufacturing and development operations. Qualifications Bachelor's degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements Demonstrated hands‑on experience working on complex projects. In‑depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. Strong partnering and communication skills required, as well as project management skills. Must be focused on working collaboratively and within our values of: Data rules, All‑in, Own it (Accountable), Caring and Humble. Ability to work effectively in a collaborative, fast‑paced environment. Strong analytical skills, excellent problem‑solving skills, and innovative thinking for sustainable practices. Strong organizational and time‑management skills with the ability to handle multiple projects. Excellent leadership and communication skills, and the ability to work in a collaborative, fast‑paced environment. Generous PTO Health Insurance & Health Savings Account Vision Insurance Employee Assistance Program (EAP) Stock Options Professional Development Opportunities 401(k) Plan Life & AD&D Insurance And More... Cirsium Biosciences is an emerging company located in San Diego, California. We offer highly competitive compensation and employee programs, including comprehensive health, dental and vision plans, generous time off, and equity in our early‑stage company. We are dedicated to fostering a workplace that keeps our team inspired and engaged. We offer an inclusive company culture where employees feel respected and valued. Cirsium Biosciences is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories. #J-18808-Ljbffr

A leading pharmaceutical company in San Diego seeks a Director, Quality Assurance (GCP) to oversee GCP QA systems, ensuring compliance with regulatory requirements. The role demands extensive experience in GCP as well as a strong leadership and auditing background. The ideal candidate will have a track record of developing quality strategies and collaborating across multiple teams. Competitive compensation includes a salary range of $176,000 - $220,000, alongside comprehensive health benefits and additional perks. #J-18808-Ljbffr

ADARx is seeking a qualified and highly motivated individual at the QA Associate III level to join the Quality Assurance (QA) group. This is a key role within the QA group and offers exciting opportunity for the successful candidate to make major contributions to the development, implementation and maintenance of the Quality Management System (QMS) at ADARx. This role will collaborate closely with CMC and Clinical functions at ADARx to ensure that quality practices, procedures, standards and systems are established and followed to maintain compliance to applicable cGxP regulations. Essential Responsibilities: Assist in the development, implementation, improvement and maintenance of ADARx's overall Quality Management System (QMS). Support the implementation of an electronic Quality Management System (eQMS) and act as the administrator to ensure proper configuration and usage of the system. Provide training and support to eQMS users. Provide QA support and oversight to internal staff and suppliers to ensure compliance with SOPs and relevant cGxP requirements. Manage the Document Control process for creating or revising controlled documents following internal procedures. Manage the training program and ensure all GxP related personnel receive appropriate training. Maintain and update training files and training curricula. Support the development of QA-related training materials and provide QA process training to new and existing employees. Author, review, and approve Quality System records, including deviation, CAPA, change records, etc. Author, review, and approve controlled documents for QA and other functional areas. Conduct and support supplier qualification activities, including issuance and review of quality questionnaires, supplier audits, and review of quality agreements. Manage supplier files and the approved supplier list to ensure they are accurate and up-to-date. Support internal audits, including planning, risk assessment, scope, audit program development, fieldwork, reporting and action follow-up. Collect and summarize Key Quality Indicator (KQI) metrics for review to identify trends. Support the preparation and hosting of regulatory inspections and external audits. Proactively identify gaps/risks and propose solutions to support continuous improvement. Essential Physical Characteristics: Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: BS/MS degree in a related scientific or technical discipline 6+ years of experience in the biotech/pharmaceutical industry 4+ years of experience in the QA function in a cGxP environment Strong understanding of cGMP and ICH regulations and guidance Demonstrated experience in development and implementation of quality processes, procedures and systems Prior experience using an eQMS is required Preferred Qualifications Previous experience in a GMP QC lab or manufacturing environment preferred GCP experience a plus Experience in implementation and/or administration of an eQMS is a plus Required Key Attributes: Must be able to work independently with supervision as needed. Must be collaborative, work well with other team members in a matrix team environment. Excellent written and verbal communication skills are essential for this role. Strong organizational skills with attention to detail and accuracy. Ability to maintain a high level of confidentiality and exercise discretion. Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges. Understand project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders. Compensation: This is a full-time position, Monday-Friday. Pay is commensurate with experience. Equity-based compensation Performance-based bonuses 401(k) with Company Match Medical, Dental, Vision Flexible Spending Account Life Insurance Employee Assistance Program Employee Discounts Gym Membership Paid Vacation Paid Holidays Paid Sick, Jury Duty, Bereavement Work Authorization: United States (Required) Background Check As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a late-clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of highly regarded investors. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law. Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses. Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.