Engineering Jobs in Ca

The Technical Sales will lead joint technology development with customers, promote the company's technology and brand, manage technical-line customer relationships, and understand and develop solutions to meet customer needs.

Key Responsibilities

• Continuously monitor and analyze industry and product technology trends, focus on customer needs, and explore potential customer requirements by focusing on high-value areas/products, and strategic projects.
• Track competitors routinely gather and analyze competitor overviews and product comparisons.
• Develop annual product plans for key customer segments, define key solutions, and set related sales targets.
• Drive Customer-segment brand planning and execution. Develop external value proposition and communication strategy for product solutions, ensure key solution messages are effectively and promptly delivered to target customers and stakeholders.
• Organize industry and customer workshops, manage customer visits, and lead event marketing activities such as promotional introductions.
• Drive high-level technical engagement with key customers, provide end-to-end solution support, articulate solution value aligned with customer needs, and build long-term customer trust and partnership.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field. Masters’ degree is a plus.
• Familiarity with WBS, PDCA cycle, SMART and 6W2H frameworks.
• Understand consumer electronics, manufacturing processes, and equipment industry.
• Good customer-centric mindset with strong service awareness.
• Ability to work under pressure and handle customer demands.
• Strong team player, able to adapt quickly to new teams and projects.
• Ability to coordinate cross-departmental collaboration to achieve goals.
• The base pay range for this role is between $85,675 and $119,945 annually and your base pay will depend on your skills, qualifications, experience, and location.

Preferred Skills

• PMP certification.
• Expertise in marketing, customer product manufacturing processes, and automation/test equipment or system development.

Job Title: Salesforce Lead Consultant - Sales & Service cloud, LWC

Location: Torrance, CA - Hybrid Must (4 Days to office) - Locals Preferred

Employment Type: Contract-To-Hire/ Fulltime/ Permanent

About Smart IT Frame:

At Smart IT Frame, we connect top talent with leading organizations across the USA. With over a decade of staffing excellence, we specialize in IT, healthcare, and professional roles, empowering both clients and candidates to grow together.

Roles and Responsibilities

Drive the architectural strategy and vision for complex enterprise solutions within the Technical Architecture family Develop and maintain architectural frameworks and governance to ensure consistency across projects Conduct architectural reviews and provide expert guidance to development teams Facilitate communication between stakeholders including business development and operations teams Identify risks and propose mitigation strategies related to architectural decisions Lead innovation initiatives by exploring new architectural styles and patterns Provide leadership in troubleshooting and resolving complex architectural issues Support the professional growth of team members through coaching and knowledge sharing

Mandatory Skills: Architecture Patterns and Styles,Microservices Architecture,Architectural diagrams,SOA and Microservices Based Architecture,Software Engineering and Design Architecture,CI/CD Architecture,Service Oriented Architecture,Architectural Patterns

Experience Level: 8 to 10 years

The Director of Manufacturing will lead the production, planning, quality inspection and inventory control teams and work with the test and engineering teams for successful LRIP (Low-Rate Initial Production) of our Subsurface Compressor Systems; perform cost reduction; improve productivity, ensure quality builds; and ensure deliveries are made on time.

Essential Duties and Responsibilities:

1. Lead and direct the manufacturing team to meet delivery commitments.
2. Develop and maintain the Master Production Schedule; identify risks and take mitigating actions to address them preemptively.
3. Ensure production builds meet delivery, design, quality and forecasted budget.
4. Drive the S&OP forecasting process based on sales outlook, fleet support and internal usage.
5. Maintain spare part requirements for the operating fleet including R&D. Drive the S&OP process through purchase approvals.
6. Institute plans to improve productivity, reduce build costs and execute high quality builds. Continue to implement KPIs for these and define and track performance metrics, including OTTR and forecast accuracy.
7. Initiate NCR and follow through to closure to correct and prevent re-occurrence of manufacturing issues.
8. Verify quality traceability in the production management systems per ISO 9001
9. Ensure build procedures are consistently followed and operators are trained.
10. Build hardware failure contingency plans for production work and field support to reduce delivery risk and lead times
11. Implement 5S, including a special focus on safety assessment and PPE.
12. Assist in dispositioning discrepant material and ensuring engineering intent is met in the manufacturing process.
13. Contribute to and comply with ISO9001.

Skills, Experience, Education, and Abilities:

• BS degree in a technical field (Manufacturing, Industrial or Mechanical Engineering preferred) or equivalent combination of education/experience.
• A minimum of 7 years progressive and related experience required.
• Demonstrated ability to support hands-on decision making, management, mentoring and development of technicians and engineers in a highly collaborative environment.
• Ability to read prints and familiar with interpretation of GD&T call outs.
• Strong understanding of geometric tolerancing per ASME Y14.5, dimensional stack-ups, inspection procedures and metrology equipment.
• Experience building turbomachinery, which includes high-speed rotating equipment, electric motors, compressors and oil management systems.
• Familiar with creating ERP system BOM’s & Routers; experience with Global Shop is a plus.
• Knowledge of standard manufacturing processes for complex, precision turbo machinery: casting, machining, milling, grinding, rotor balancing, mechanical and electrical assembly, inspection techniques, oil management systems (tubing, fittings, etc.) and pressurized assemblies.
• Experience with NPI of complex equipment.
• Kaizen, 5S, Six Sigma, Demand Flow Technology, Lean Manufacturing, ISO 9001 experience is a plus.
• Experience configuring assembly lines, in-process Kanban’s and visual work instructions is a plus.
• Good interpersonal and interfacing skills (i.e. communicating well with people across different departments both internally and externally)
• Additional computer skills: Microsoft Office Suite

Intangibles Sought:

• Able to exercise independent judgment and make decisions on technical issues.
• Ability to establish positive rapport with individuals at all levels of organization.
• Ability to motivate working team through leadership and “can do” attitude.
• Self-awareness; not afraid to ask for help or admit error.
• Willingness to engage in constructive debate.
• Ownership, initiative and accountability.
• Flexibility in range of responsibilities.

Supervisory Responsibilities:

Position will lead the manufacturing team. Position will be responsible for directing and coordinating activities of others to meet company objectives.

Physical Demands / Work Environment:

Time will be split between office and shop floor. Personal protective equipment, such as safety glasses, gloves, or masks may be required in some assembly areas. Some travel will be required as needed for vendor visits/qualifications.

Ray Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation.

We are currently seeking a highly motivated and detail-oriented VP of Quality and Compliance to join our team in the mission to restore vision to patients. This role will report to the Chief Development Officer

The selected candidate will work closely with our Clinical and CMC teams and establish the Quality Department. The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and/or Quality Control functions. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and will require 15-20% domestic travel to our contract development and manufacturing organizations in the United States.

Position Overview:

The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and Quality Control functions. They are responsible for leading all quality control systems, regulatory compliance, and safety, ensuring products/services meet industry standards. They are responsible for clinical and CMC quality requirements, vendor management, internal and external compliance, and ensuring that AAV drug substance and product manufacturing, testing, and release meet FDA, EMA, and ICH regulatory standards, from clinical stage to commercialization.

The Vice President of Quality will establish, lead and develop the quality function, in line with the company's stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment.

Essential Duties and Responsibilities:

• Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical CROs and CMC CDMO’s
• Maintain efficient systems and processes that ensure RayTx and its vendor network comply with GXP standards
• Ensure the appropriate identification, evaluation, and management of risks associated with quality
• Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations
• Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle
• Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues
• Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations
• Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP activities
• Prior experience establishing a Quality Department and growing a group.
• Strong knowledge and understanding of clinical trial design.
• Quality Management System (QMS) Oversight:Develop, implement, and maintain robust quality systems, including document control, change control, deviation management, and CAPA (Corrective and Preventive Actions).
• Provide expert quality oversight on AAV manufacturing processes, analytical method validations, and comparability studies.
• Prior experience developing GCP / GMP auditing plans.
• Regulatory Compliance: Ensure site compliance with global regulations (FDA, EMA) and lead audit readiness efforts (internal and external inspections).
• Batch Disposition: enact internal quality reviews of GMP batch records, and management of finalization and release of clinical or commercial AAV vectors.
• Vendor Management: Oversee quality agreements and audits for Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CRO’s).
• Team Leadership: Mentor and lead quality personnel, fostering a culture of quality, safety, and operational excellence

Qualifications and Experience:

• Minimum bachelor's degree in relevant scientific or engineering discipline.
• 8+ years relevant biotech experience.
• Experience in GMP AAV gene therapy manufacturing preferred.
• Knowledge of AAV analytical methods and testing preferred.
• Experience working with CDMO, CRO’s, and other external vendors preferred.
• Experience with clinical quality oversight, SOP generation
• Experience with vendor management and audit planning
• Excellent scientific knowledge and acumen.
• Familiarity with regulatory requirements and documentation
• Ability to travel up to 20%

Compensation Range and Benefits:

• The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
• Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.

Search Firm Representatives Please Read Carefully

Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.

Overview:

We are seeking an experienced Beverage Production Manager to oversee the daily operations of our production facility. In this critical role, you will lead a team of production and maintenance staff to ensure efficient manufacturing of high-quality cannabis‑infused beverages, including soft drinks, juices, RTD teas, or similar products.

The ideal candidate is a hands-on leader with deep knowledge of food and beverage production processes, quality standards, and safety regulations. You will drive operational excellence, optimize production efficiency, and contribute to scaling our production capacity while maintaining product integrity and cost control. You should be comfortable working in a rapidly evolving segment of the beverage industry, able to adapt quickly to changing regulations and market demands.

Responsibilities:

• Plan, schedule, and supervise all production activities to meet daily, weekly, and monthly targets. Monitor production lines for efficiency, output, and quality.
• Manage, train, and develop a team of 50+ production associates, including hiring, performance evaluations, and fostering a positive work environment.
• Implement and enforce HACCP, CDPH, DCC, and SQF standards to ensure product safety, consistency, and compliance. Conduct regular audits and troubleshoot quality issues.
• Identify opportunities for process improvements, equipment upgrades, and cost reductions using lean manufacturing principles, Six Sigma, or similar methodologies.
• Prepare production reports, analyze KPIs (e.g., OEE, yield, downtime), and present data‑driven insights to senior leadership.
• Collaborate with maintenance teams to ensure equipment reliability. Champion workplace safety protocols, conduct risk assessments, and maintain OSHA compliance.

Required Skills:

• Bachelor’s degree in Food Science, Engineering, Operations Management, or a related field.
• Must have Lean Manufacturing certifications (e.g., Six Sigma Green Belt, PMP)
• 5+ years of experience in beverage production management, with at least 2 years in a supervisory role.
• Proven track record in high‑volume manufacturing environments (e.g., bottling lines, canning, aseptic processing).
• 5+ years of exp in working in high‑volume manufacturing environments (e.g., bottling lines, canning, aseptic processing)
• Strong knowledge of GMPs, HACCP, DCC regulations, and food safety standards.
• Exp with ERP systems like SAP or Oracle
• Bilingual (Spanish).

Be the quality champion who ensures every product we design meets the highest engineering, customer, and regulatory standards!

As a Design Quality Assurance (DQA) Engineer, you’ll play a pivotal role in guiding product development from concept through full life‑cycle compliance. You’ll ensure that all engineering work follows Teledyne Controls’ established design standards, development processes, and work instructions while verifying that resulting products and documentation meet contractual obligations, customer quality requirements, industry standards, and regulatory guidelines. This role directly supports engineering excellence—helping teams build reliable, compliant, and high‑performing aerospace products that our customers can trust.

What You'll Do

• Review Original Equipment Manufacturer (OEM) & Airline Customers quality provisions as part of contract review or contract formation for new proposals or contracts.
• Ensure compliance with OEM and Airline Customers imposed contract provisions – Quality Management System (QMS) Policies/ Processes/ Development requirements.
• Ensure compliance with Teledyne Controls Quality Management System (QMS) Policies/ Processes/ Development requirements and applicable OEM or Airline Customers approved contract quality provisions.
• Create or update Software Quality Assurance Plans (SQAPs) or Hardware Quality Assurance Plans (HQAPs) – for customer submission and approval.
• Support coordination and liaison with Customers for development programs quality related issues, concerns, plan of action(s), and resolution.
• Perform product life cycle documentation reviews and process audits. Review and approve Engineering documentation, design changes (EOs) and development folders.
• Participate in Systems, Hardware, and Software design & development reviews process covering: Planning, Requirements, Design, and Verification & Validation(V&V); and support development programs formal customer reviews such as: Plan Review (PL), Requirements Review (RR), Preliminary Design Review (PDR), Critical Design Review (CDR), Test Readiness Review (TRR), and Production Readiness Review (PRR).
• Support Engineering Test Procedure (ETP)/System Test monitoring, Test Set-up Conformity, and review Test Reports and failure investigations reports.
• Support Qualification test monitoring, Test Set-up Conformity; and review Qualification Test Reports and failure investigations reports.
• Plan, perform, and support hardware or software product conformity, First Article Inspection review and audits; and support Stage of Involvement (SOI) reviews and audits.
• Oversee product change management submission and approval process for compliance with OEM customers’ requirements (EDES, NOC, etc.).
• Support Product transition processes to Manufacturing in collaboration with Factory Quality Control, Supplier Quality Control, and Manufacturing Engineering.
• Support and conduct Internal AS9100 Audits, customers requested audits, and internal audit program.

What You Need

• Bachelor’s degree in quality engineering or other related Engineering discipline,
• 7+ years of experience applying quality improvement methodologies, tools, and techniques, or equivalent experience in product design and development within AS9100/ISO 9001 environments and working with QMS standards.
• Strong working knowledge of DO‑178 software compliance and DO‑254 hardware compliance is highly desired.
• Familiarity with AS9145, including APQP and PPAP processes, is preferred.
• Ability to provide clear guidance and establish quality positions on program development and compliance issues for program management and engineering teams.
• Experience with MRP or ERP systems is preferred.
• ASQ certification is preferred.
• Must be a U.S. Person (includes U.S. citizens, lawful permanent residents, refugees, and asylees)

Salary: Up to 120K depending on experience

What We Offer

• Competitive pay and comprehensive health benefits
• 401(k) with company match and retirement plans
• Paid time off and flexible work arrangements
• Professional development and training opportunities
• Employee wellness programs and assistance resources
• A collaborative environment focused on innovation and safety

What Happens Next

Apply online through Teledyne’s careers page. If your qualifications align, our team will contact you for interviews and guide you through the process.

Teledyne is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Employment is contingent on background checks and compliance with applicable regulations.

AI Research Scientist | Machine Learning | Deep Learning | Natural Language Processing | LLM | Hybrid | San Jose, CA

Title: AI Research Scientist

Location: San Jose, CA

Responsibilities:

• Design, execute, and analyze machine learning experiments, establishing strong baselines and selecting appropriate evaluation metrics.
• Stay up to date with the latest AI research; identify, adapt, and validate novel techniques for company-specific use cases.
• Define rigorous evaluation protocols, including offline metrics, user studies, and adversarial (red team) testing to ensure statistical soundness.
• Specify data and annotation requirements; develop annotation guidelines and oversee quality control processes.
• Collaborate closely with domain experts, product managers, and engineering teams to refine problem statements and operational constraints.
• Develop reusable research assets such as datasets, modular code components, evaluation suites, and comprehensive documentation.
• Work alongside ML Engineers to optimize training and inference pipelines, ensuring seamless integration into production systems.
• Contribute to academic publications and represent the company in research communities, as needed.

Educational Qualifications:

• Ph.D. in Computer Science, Artificial Intelligence, Machine Learning, or a related field is strongly preferred.
• Candidates with a master’s degree and exceptional research or industry experience will also be considered.

Industry Experience:

• 3–5 years of experience in AI/ML research roles, ideally in applied or product-focused environments.
• Demonstrated success in delivering research-driven solutions that have been deployed in production.
• Experience collaborating in cross-functional teams across research, engineering, and product.
• Publications in top-tier AI/ML conferences (e.g., NeurIPS, ICML, ACL, CVPR) are a plus.

Technical Skills:

• Strong foundational knowledge in machine learning and deep learning algorithms.
• Hands-on experience with PEFT/LoRA, adapters, fine-tuning techniques, and RLHF/RLAIF (e.g., PPO, DPO, GRPO).
• Ability to read, implement, and adapt state-of-the-art research papers to real-world use cases.
• Proficiency in hypothesis-driven experimentation, ablation studies, and statistically sound evaluations.
• Advanced programming skills in Python (preferred), C++, or Java.
• Experience with deep learning frameworks such as PyTorch, Hugging Face, NumPy, etc.
• Strong mathematical foundations in probability, linear algebra, and calculus.
• Domain expertise in one or more areas: natural language processing (NLP), symbolic reasoning, speech processing, etc.
• Ability to translate research insights into roadmaps, technical specifications, and product improvements.

AI Research Scientist | Machine Learning | Deep Learning | Natural Language Processing | LLM | Hybrid | San Jose, CA

Job Title: Stationary Engineer

Unit: Plant Maintenance

Location: Marina del Rey, CA (Locals Only)

Shift: Day 3x12-Hour (07:00 - 19:00)

Start Date: 05/04/2026

Job Duration: 35 Weeks

Gross weekly: $1944.00

***POSITION REQUIRES WEEKEND AVAILABILITY***

*** ROTATING SCHEDULE***

Required:

• HSD/GED
• Vocation/Technical diploma for Stationary Engineering
• 2 years of experience as an apprentice or journey-level Stationary Engineer
• Experience working in a hospital, healthcare, or complex facility environment
• Steam Engineer license (500 HP or greater)
• EPA Universal Certification for handling refrigerants
• Los Angeles Unlimited Steam Engineer License (issued by the city of LA)

Preferred:

• Prior lead, foreman, or supervisor experience

Primary Duties and Responsibilities:

• Operates, monitors, and maintains boilers, chillers, generators, compressors, pumps, and related central plant equipment to ensure uninterrupted mechanical power and utility services throughout the hospital.
• Performs preventive maintenance, inspections, and operational checks on facility systems and equipment to support safe and reliable operations.
• Troubleshoots mechanical, electrical, and control system issues and implements corrective actions to minimize equipment downtime and operational disruptions.
• Utilizes hand tools, diagnostic instruments, and testing equipment to evaluate system performance and complete assigned maintenance tasks.
• Monitors building automation and management systems to ensure optimal performance of heating, ventilation, air conditioning, and utility systems.
• Responds to system alarms, equipment failures, and urgent maintenance requests in a timely manner to support hospital operations and patient care needs.
• Maintains accurate logs, records, and documentation related to equipment operation, maintenance activities, and regulatory compliance requirements.
• Ensures compliance with safety standards, regulatory requirements, and hospital policies while performing maintenance and operational duties.
• Assists in coordinating maintenance activities and work assignments to support departmental priorities and operational efficiency.
• Collaborates with facilities management, engineering staff, and other hospital departments to address operational needs and resolve facility-related concerns.
• Participates in system testing, start-up, and shutdown procedures for equipment and utilities as required.
• Supports emergency preparedness efforts by assisting with backup power operations, disaster response activities, and restoration of services following outages or incidents.
• Identifies equipment performance issues, maintenance needs, and opportunities for operational improvements and communicates recommendations to leadership.

Interested candidates, please reach out directly to my recruiter at or (215)-559-9446

Machine Learning Engineer | Python | Pytorch | Distributed Training | Optimisation | GPU | Hybrid, San Jose, CA

Title: Machine Learning Engineer

Location: San Jose, CA

Responsibilities:

• Productize and optimize models from Research into reliable, performant, and cost-efficient services with clear SLOs (latency, availability, cost).
• Scale training across nodes/GPUs (DDP/FSDP/ZeRO, pipeline/tensor parallelism) and own throughput/time-to-train using profiling and optimization.
• Implement model-efficiency techniques (quantization, distillation, pruning, KV-cache, Flash Attention) for training and inference without materially degrading quality.
• Build and maintain model-serving systems (vLLM/Triton/TGI/ONNX/TensorRT/AITemplate) with batching, streaming, caching, and memory management.
• Integrate with vector/feature stores and data pipelines (FAISS/Milvus/Pinecone/pgvector; Parquet/Delta) as needed for production.
• Define and track performance and cost KPIs; run continuous improvement loops and capacity planning.
• Partner with ML Ops on CI/CD, telemetry/observability, model registries; partner with Scientists on reproducible handoffs and evaluations.

Educational Qualifications:

• Bachelors in computer science, Electrical/Computer Engineering, or a related field required; Master’s preferred (or equivalent industry experience).
• Strong systems/ML engineering with exposure to distributed training and inference optimization.

Industry Experience:

• 3–5 years in ML/AI engineering roles owning training and/or serving in production at scale.
• Demonstrated success delivering high-throughput, low-latency ML services with reliability and cost improvements.
• Experience collaborating across Research, Platform/Infra, Data, and Product functions.

Technical Skills:

• Familiarity with deep learning frameworks: PyTorch (primary), TensorFlow.
• Exposure to large model training techniques (DDP, FSDP, ZeRO, pipeline/tensor parallelism); distributed training experience a plus
• Optimization: experience profiling and optimizing code execution and model inference: (PTQ/QAT/AWQ/GPTQ), pruning, distillation, KV-cache optimization, Flash Attention
• Scalable serving: autoscaling, load balancing, streaming, batching, caching; collaboration with platform engineers.
• Data & storage: SQL/NoSQL, vector stores (FAISS/Milvus/Pinecone/pgvector), Parquet/Delta, object stores.
• Write performant, maintainable code
• Understanding of the full ML lifecycle: data collection, model training, deployment, inference, optimization, and evaluation.

Machine Learning Engineer | Python | Pytorch | Distributed Training | Optimisation | GPU | Hybrid, San Jose, CA

Job Title: QA Consultant (GxP)

Location: San Diego, CA (On-site)

Position Type: Contract / Consultant

Department: Quality Assurance

Reports To: Site Quality Head / Director, QA

Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed

About Us

Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need.

Position Summary

The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions.

You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams.

Key Responsibilities

Support concurrent activities for legacy Quality systems during QMS integration and system migration phases.

Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems.

Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls.

Operate and support legacy Quality systems during the transition to new platforms.

Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records.

Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA).

Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records.

Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS).

Support continuous improvement efforts for events within EDMS and LMS.

Work with document owners to ensure timely periodic review of procedures.

Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools.

Generate and trend quality metrics, communicating findings to leadership.

Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans.

Review and approve paper-based quality documentation and electronic quality records.

Promote a culture of quality, teamwork, and accountability with a patient-first mindset.

Align daily activities with department goals and company values.

Ability to lift up to 20 pounds as needed.

Qualifications

Education: Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered).

Experience: Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred).

Technical Skills:

Strong knowledge of Quality Management Systems in a cGxP manufacturing environment.

Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.

Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) such as ComplianceWire or Qualio.

Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).

Competencies:

Exceptional written and verbal communication skills.

Strong attention to detail and ability to manage multiple projects simultaneously.

Proven ability to work independently and collaboratively in a fast-paced, dynamic environment.

Experience developing training materials and delivering training to employees.

Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents.