Compliance Specialist

2 months ago

Fremont, United States Catalyx Full time

Catalyx is seeking a Compliance Specialist to join our team in Fremont, Ca.


Who We Are:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.


The Role:

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organizations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.


We are seeking an experienced and driven Compliance Specialist to assist us with a major pharmaceutical client.



Responsibilities:


Individual contributor responsible to manage change control records and lead projects in support of Manufacturing Operations. This position will support in the monitoring, reporting of deviations, change controls and improvement projects. This position is responsible to own and change control records, CAPAs and Periodic Review documents and SOP revisions.

Helps to Identify areas for Continuous Process Improvement and applies operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains.


Skills and Experience:


Possesses knowledge in the area of manufacturing biopharmaceuticals.

Experience in managing simple to moderate projects, and CAPA.

Possesses knowledge of cGMP systems and of regulations from different regional jurisdictions.

Some knowledge of change controls, deviations, project management, and audits/inspections.

Some experience leading meetings, and mastery of some techniques to keep meetings effective and team on task.

Projects are cross functional, and the project scope is limited.

The specialist should be able to independently influence peers to achieve a common goal.

Experience writing technically (e.g. SOPs or protocols, or deviations, etc.)


Time management:

Must be able to multi-task and be organized.

Experience in biotech and pharmaceutical manufacturing is a requirement.

Preferable experience being a manufacturing operator or technician.

Education:

Bachelor’s degree with a focus in Biopharmaceuticals.

Experience: 2 Years Experience with cGMP and biopharma.



Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.


Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.


At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.

  • Transportation Compliance Specialist

    3 weeks ago

    Fremont, United States LT Corporation, Inc. Full time

    About the Job:LT Corporation, Inc. is seeking a highly skilled Transportation Compliance Specialist to join our team. In this role, you will be responsible for managing compliance and driver safety within all operational areas, including truck inspections, medical certificates, licensing, driver log management, drug and alcohol testing, and hours of...

  • Clinical Compliance Specialist

    5 days ago

    Fremont, Michigan, United States Corewell Health Full time

    Corewell Health OverviewThe Clinical Regulatory Compliance Specialist plays a vital role in supporting the organization's commitment to health and wellness. At Corewell Health, we strive to provide a safe environment for our team members, patients, visitors, and community.Scope of WorkThis position assists with management of compliance and/or accreditation...

  • Documentation and Compliance Specialist

    3 weeks ago

    Fremont, California, United States Specialized Coating Services Full time

    Job OverviewWe are seeking a skilled Documentation and Compliance Specialist to join our team at Specialized Coating Services in Fremont.This full-time position offers a competitive salary, benefits, and the opportunity to work with a growing manufacturing company.About the RoleThe successful candidate will be responsible for developing and implementing...

  • Environmental Product Compliance Specialist

    1 day ago

    Fremont, California, United States Info Way Solutions Full time

    We are looking for a seasoned Environmental Product Compliance Specialist to join our team at Info Way Solutions. The successful candidate will be responsible for ensuring that our software solutions meet the highest standards of environmental product compliance.About the Company:Info Way Solutions is a leading provider of software solutions for the...

  • Regulatory Compliance Project Lead

    4 weeks ago

    Fremont, California, United States Catalyx Full time

    About the RoleCatalyx is seeking a skilled Compliance Specialist to join our team. As a key member of our manufacturing operations, you will play a vital role in ensuring compliance with regulatory requirements.This is an exciting opportunity for an individual contributor who is passionate about delivering high-quality results and driving continuous process...

  • MFG Compliance Specialist

    2 months ago

    Fremont, United States Planet Pharma Full time

    1st Shift: Mon-Fri, 8:00AM-5:00PM$35 - $47.50 6 month extendable CONTRACT Fremont, CA - onsite Duties: Individual contributor responsible to manage change control records and lead projects in support of Manufacturing Operations.This position will support in the monitoring, reporting of deviations, change controls and improvement projects.This position is...

  • Fleet and Safety Compliance Manager

    1 month ago

    Fremont, United States LT Corporation, Inc. Full time

    Position Description for Transportation Manager, LT Corp LogisticsCompany: LT Corp LogisticsReports to: Director, LT Corp LogisticsLocation: Fremont, OHCompany Overview:LT Corporation (LT Corp), based in Cleveland, Mississippi, is the parent company of a Family of Companies including Buckeye Fabricating Company, Kryton Engineered Metals, LP Cylinder Service,...

  • RN Clinical Regulatory Compliance Specialist

    7 months ago

    Fremont, United States Spectrum Health Full time

    This is a corporate position with primary work supporting Clinical Compliance, Accreditation and Regulatory Compliance at Corewell Health Ludington and Gerber Hospitals. About Corewell Health Our new name signals our bold commitment to health and wellness. At our core, we are here to help people be well so they can live their healthiest life possible....

  • Validation and Compliance Specialist

    6 days ago

    Fremont, California, United States Fladger Assoc. Inc. Full time

    About UsAt Fladger Assoc. Inc., we are committed to delivering high-quality services that meet the needs of our clients. As a Validation Engineer, you will play a critical role in ensuring the quality and integrity of our processes.The estimated salary for this role is $120,000 per year, which is negotiable based on experience.Key...

  • Asset Protection Specialist

    3 weeks ago

    Fremont, United States Home Depot Full time

    Home Depot - JobID: 61E245F1C5554D618DA7220927CF6DF4 [Loss Prevention / Security] As an Asset Protection Specialist at Home Depot, you'll: Prevent financial loss caused by theft and fraud; Support safety and environmental program compliance in your assigned store/multiple stores; Identify incidents of theft and fraud, review CCTV and exception reports,...

  • Cloud Security Specialist

    7 days ago

    Fremont, California, United States Info Way Solutions Full time

    We are seeking a seasoned Cloud Security Specialist to join our Info Way Solutions team in Phoenix, AZ. This position comes with a competitive salary of $150,000 - $200,000 per year.About the Role:The Cloud Security Specialist will be responsible for ensuring the security and integrity of our cloud-based infrastructure. The ideal candidate will possess a...

  • Occupational Therapy Specialist

    6 days ago

    Fremont, California, United States Fremont Healthcare Center Full time

    Occupational Therapy Specialist WantedFremont Healthcare Center is seeking an experienced Occupational Therapy Specialist to join our team.About the JobThis 13-week contract position involves working with patients to develop and implement occupational therapy interventions. As an Occupational Therapy Specialist, you will be responsible for conducting...

  • Quality Assurance Compliance Specialist III: Expert in Regulatory Excellence

    3 weeks ago

    Fremont, California, United States Ardelyx Full time

    Company OverviewArdelyx is a leading commercial biopharmaceutical company dedicated to discovering, developing, and commercializing innovative first-in-class medicines that address significant unmet medical needs. With a strong focus on quality and compliance, Ardelyx has established itself as a trusted partner in the industry.SalaryThe anticipated...

  • Meat Quality Assurance Specialist

    2 weeks ago

    Fremont, California, United States US1224 Newport Meat Northern California, Inc. Full time

    US1224 Newport Meat Northern California, Inc. is seeking a skilled Meat Quality Assurance Specialist to join our team in the meat and seafood industry. This role plays a vital part in ensuring compliance with corporate and regulatory requirements.About the RoleWe are looking for an experienced professional to monitor and evaluate Food Safety & Quality...

  • Warehouse Support Specialist

    6 days ago

    Fremont, California, United States Home Depot Full time

    **Job Overview**The Home Depot is seeking a highly skilled and detail-oriented Warehouse Support Specialist to join our team in the Distribution Center. In this role, you will be responsible for ensuring inventory accuracy within the processing areas, system quality, and vendor compliance.We are an Equal Opportunity Employer and offer a competitive salary of...

  • Seasonal Tax Specialist

    6 days ago

    Fremont, California, United States Jackson Hewitt - HSF Full time

    About the RoleThis Seasonal Tax Specialist position offers an exciting opportunity to join our team and utilize your tax expertise to make a difference for clients. With a focus on delivering exceptional client service, this role requires a strong passion for helping others and a willingness to learn and grow.Key ResponsibilitiesProvide expert tax...

  • Cloud Infrastructure Specialist

    3 weeks ago

    Fremont, California, United States AMAX Full time

    Cloud Infrastructure SpecialistWe are seeking a skilled Cloud Infrastructure Specialist to join our team at AMAX. In this role, you will be responsible for designing, deploying, and managing cloud infrastructure specifically tailored for GPU hosting.Key Responsibilities:Design and deploy cloud infrastructure for GPU hosting.Optimize GPU utilization and...

  • Pharmacy Quality Assurance Specialist

    4 weeks ago

    Fremont, United States RPh on the Go Full time

    Job Title: Pharmacy Quality Assurance SpecialistAbout the Job:Assist the pharmacy department in meeting quality and regulatory goals.Ensure compliance with industry standards and best practices.Collaborate with the team to implement pharmacy automation processes.Requirements:Minimum 1+ years of pharmacy experience required.Experience with Pyxis automated...

  • Coding Specialist

    3 weeks ago

    Fremont, California, United States Washington Township Medical Foundation Full time

    Certified Coding SpecialistJob Overview:The Washington Township Medical Foundation seeks a skilled Certified Coding Specialist to join our team. This role is responsible for accurately assigning codes to medical records, ensuring optimal reimbursement and compliance with coding guidelines.About the Role:We are seeking an individual with excellent analytical...

  • Diagnostic Imaging Specialist

    3 weeks ago

    Fremont, California, United States beBee Professionals Full time $60,000 - $80,000

    Overview">We are seeking a highly skilled Diagnostic Imaging Specialist to join our team at beBee Professionals in Fremont. This exciting opportunity will involve conducting diagnostic imaging procedures and ensuring the highest quality of patient care.">About the Role">This role is ideal for a dedicated professional with experience in diagnostic imaging,...