89 Pharmaceutical Company jobs in Rahway

• The Regulatory Affairs Associate, with minimal guidance prepares, reviews and submits high quality annual reports with FDA within Annual report timelines and in accordance with regulatory guidelines and applicable federal laws.
• With minimal guidance, ensure to compile and complete the Annual reports of high-quality, following the regulatory guidelines and internal processes within time lines.
• Coordinate with all supporting departments for obtaining documents for annual report submissions.
• Should archive and maintain all post approval submissions in a systematic way in RA library.
• ssists in Projects Assigned for Post-Approval team (Client, CBE-30, CBE0).
• ssists technical services team by providing required information from the submissions as and when required.
• Organize and maintain submission components associated with a regulatory submission electronically.
• This may include scanning, converting to pdf, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress etc. under superior guidance.
• Gain more knowledge in the use of e-CTD structures for submissions.
• Works with colleagues in resolving regulatory issues and/or problem.
• Should archive and maintain all submissions in a systematic way.
• Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.
• Maintain current knowledge of regulations and other issues that affect products and industry.
• Maintain the regulatory databases up to date and as per the set criteria.

• Master's degree is Science or Technical, at least 3 Years of experience in Pharmaceutical Industry.
• Regulatory Affairs or related coursework.
• Working knowledge and experience with 21 CFR, US FDA guidance, ICH guidelines.
• Strong computer skills to learn new programs as quickly as possible.
• Experience in MS Word, Excel, Outlook and Adobe Acrobat is a must.
• Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required.
• bility to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.
• Excellent written and verbal communication skills and interpersonal skills.
• bility to communicate effectively and collaboratively as part of a team in a respectful manner.
• bility to work independently, self-starter.
• Good problem-solving skills and analytical ability.
• Strong computer skills to learn new programs as quickly as possible.
• Experience in MS Word, Excel, Outlook, and Adobe Acrobat is a must.

• Provide technical support to sales teams and account managers internally and/or during interactions with clients.
• Support responses to tenders and/or projects from a technical perspective
• Lead and support retailer programs for products within the business unit
• Support tracking of open and incoming order for local C&H laboratory
• Prepare or support the preparation of test plans, test protocols and / or SOPs according to regulatory and/or client requirements
• Train and prepare reports in the area of desktop reviews (ingredient and product label reviews in accordance with applicable US / Canada laws and regulations)
• Lead and support the execution of sensory and consumer panel testing plans
• Stay up to date on applicable and upcoming federal and state laws, hazardous materials regulations, and other applicable US / Canada laws and regulations applicable to cosmetics, personal care and household products
• Create/Review/Send test reports as required
• Additional responsibilities as assigned by supervisor

• Bachelor's degree within a scientific discipline such as chemistry, microbiology, etc Required
• Knowledge / experience of the cosmetics, personal care and/or household care sector Required
• Minimum 1-3 years of relevant experience Required
• Knowledge / experience in cosmetics, personal care or household care related testing services (microbiology, chemical, etc.) desirable Preferred
• Regulatory knowledge / experience desirable Preferred
• Knowledge or understanding of sensory testing Preferred

Direct message the job poster from Aequor Information Technologies Pvt. Ltd.

The Compliance Specialist is responsible to support Manufacturing by investigating, authoring and managing non-conformance reports (NCRs) for production and environmental monitoring (EM) events. Assign corrective and preventative actions (CAPAs) and effectiveness checks (ECs) to address issues identified throughout production. Work with cross-functional teams, including production, quality control, quality assurance and facilities , to ensure efficient problem-solving and resolution of non-conformance issues. Communicate findings, actions, and improvements to relevant stakeholders and management.

Key Responsibilities:

Non-Conformance Report (Client) Management:

- Investigate both significant and non-significant NCRs for production and EM events.

- Analyze data and Identify the root causes to ensure a thorough investigation and identification of underlying issues.

- Write and maintain comprehensive Client reports, including all necessary details such as cause, impact, and actions taken.

Corrective and Preventative Actions (CAPA):

- Work closely with cross-functional teams to develop and implement corrective and preventative actions in response to Client findings.

- Ensure CAPAs are well-defined, actionable, and address the root cause effectively.

- Monitor and track the progress of CAPAs, ensuring timely resolution and documentation of outcomes.

Effectiveness Checks (EC):

- Conduct effectiveness checks (ECs) to assess the success of implemented CAPAs and Client resolutions.

- Analyze the results of effectiveness checks to ensure that corrective actions have been effective in preventing recurrence.

- Recommend further adjustments to CAPAs if necessary, based on the effectiveness checks.

- Attention to detail and thoroughness in investigation.

- Ability to work independently and manage multiple tasks simultaneously.

- Strong collaboration and interpersonal skills to work across teams.

- Ability to analyze data and identify trends or areas for improvement.

Education:

- High School Diploma or GED and 8-10years experience preferred

- Bachelors Degree in Engineering, Life Sciences, or related field (5-7 years experience preferred)

Qualification:

- 2+ years of experience in manufacturing, quality assurance, or related fields, with experience in managing NCRs, CAPAs and ECs.

- Knowledge of industry regulations such as GMP, ISO 9001, and FDA guidelines.

- Strong analytical, problem-solving, and investigative skills.

- Excellent written and verbal communication skills.

- Proficient in Microsoft Office Suite and document control software.

• Seniority level Associate

• Employment type Contract

• Job function Quality Assurance, Manufacturing, and Research
• Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.

Why ImmunityBio?
* ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
* Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
* Work with a collaborative team with the ability to work across different areas of the company.
* Ability to join a growing company with professional development opportunities.

Position Summary

The Principal, Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements.

Essential Functions

• Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization.
• Approve, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirements
• Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products.
• Assist with developing and evaluating regulatory strategy
• Keep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on ImmunityBio products.
• Author and review departmental SOPs, as well as other SOPs that may impact Regulatory Affairs.
• Performs other special projects and duties as requested.

Education & Experience

• Bachelor's Degree in life sciences required; Master's degree preferred
• 10+ years of relevant regulatory compliance experience in pharmaceutical drug development required
• Knowledge and experience with organizing responses to Regulatory Authority requests required
• Experience with US and International Health Authority regulatory submissions preferred

Knowledge, Skills, & Abilities

• Knowledge of FDA, ICH and other guidance documents and requirements
• Knowledge of organizing responses to Regulatory Authority requests

• Strong knowledge of Health Authority regulatory requirements/guidelines
• Strong project management and computer skills (including Microsoft office)
• Strong document management experience (hard and e-copy)
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organizational skills, written/oral communication skills and attention to detail
• Ability to manage conflicting priorities and respond in a timely, effective manner

Working Environment / Physical Environment

• This is a full-time position (40 hours per week) Monday through Friday.
• This role may need to sit for long periods of time and use various computer programs.
• This desk-based role involves the close study of scientific and regulatory documents.
• They will work closely with scientific colleagues throughout the day, often on a project team basis.

Position Summary

The Principal, Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements.

Essential Functions

• Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization.
• Approve, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirements
• Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products.
• Assist with developing and evaluating regulatory strategy
• Keep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on ImmunityBio products.
• Author and review departmental SOPs, as well as other SOPs that may impact Regulatory Affairs.
• Performs other special projects and duties as requested.

Education & Experience

• Bachelor's Degree in life sciences required; Master's degree preferred
• 10+ years of relevant regulatory compliance experience in pharmaceutical drug development required
• Knowledge and experience with organizing responses to Regulatory Authority requests required
• Experience with US and International Health Authority regulatory submissions preferred

Knowledge, Skills, & Abilities

• Knowledge of FDA, ICH and other guidance documents and requirements
• Knowledge of organizing responses to Regulatory Authority requests

• Strong knowledge of Health Authority regulatory requirements/guidelines
• Strong project management and computer skills (including Microsoft office)
• Strong document management experience (hard and e-copy)
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organizational skills, written/oral communication skills and attention to detail
• Ability to manage conflicting priorities and respond in a timely, effective manner

Working Environment / Physical Environment

• This is a full-time position (40 hours per week) Monday through Friday.
• This role may need to sit for long periods of time and use various computer programs.
• This desk-based role involves the close study of scientific and regulatory documents.
• They will work closely with scientific colleagues throughout the day, often on a project team basis.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

$162,000 (entry-level qualifications) to $180,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Role Overview

This is an entry-level regulatory affairs associate position. The candidate needs to have the ability to pay close attention to details, be proficient in Word and Excel, and have excellent writing and communication skills. Interpret and apply regulations.

Primary Duties & Responsibilities

• Monitor and maintain current regulatory requirements and guidelines.
• Assist with the planning, writing and reviewing of regulatory documents including ad promo submissions, regulatory meeting documents, NDAs, annual reports, PADERs, amendments, and supplements to ensure high quality regulatory submissions.
• Assist with eCTD publishing of sequences.
• Manage and track labeling changes including drug registration and listing.
• Manage FDA correspondence including tracking logs of submissions and reports.
• Manage PO creation including setup of new vendors.
• Manage and coordinate timely renewals of state distribution licenses.
• Assist with miscellaneous regulatory-related administrative activities.

• Education: Bachelor of Science in Chemistry or Biology, PharmD preferred
• Languages: Fluent in English, proficiency in Spanish is desirable

• Specific Knowledge: Strong written and oral communication skills. Attention to detail, analytical, computer literacy, communication, problem-solving, and listening skills.
• Personal skills: Please list all that apply General management skills, strong interpersonal and people development skills, strong results-orientation, superior leadership skills, ability to anticipate problems and solve them

• Is required to interact with internal and external contacts independently
• Is regularly required to talk or hear either in person, videoconference or over a dial tone phone, as well as a mobile phone, when applicable.
• Is often required to sit and occasionally to stand, walk, bend, or lift.
• Is required to occasionally lift office products and supplies, up to 40
• Is desk-based and may be sitting for long periods of
• Must regularly use fingers and hands for fine manipulation: typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer)
• Must communicate clearly: video calls, phone calls, emails, in-person conversations
• Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive

• Contracts and Agreements :
• Review, draft, negotiate, and process agreements and amendments per organizational guidelines.
• Audit and Survey Management :
• Manage projects involving the collection and submission of data and information related to government audits, surveys, and requests.
• Provider Relations and Contracting :
• Handle provider contracting, including letters of agreement, and conduct follow-up.
• Fair Hearing (FH) Management :
• Review, disseminate, and handle FH notices; manage the FH calendar; conduct preparations for FHs and attend as needed.
• Review and handle communications and submit reports.
• Prepare status reports and updates on cases.
• Special Investigations :
• Handle activities of the Special Investigation Unit (SIU), including reporting and internal investigations.
• HIPAA Compliance :
• Update applicable HIPAA policies and procedures in compliance with laws and regulations.
• OIG/OMIG Compliance :
• Review OIG/OMIG requirements and best practices; update compliance materials, policies, and procedures to ensure adherence to regulations.
• DOH and CMS Contracts :
• Review and edit DOH and CMS plan contracts to ensure compliance with contract requirements.
• Regulatory Guidance :
• Review and disseminate CMS memos and DOH guidance, keeping up to date on laws and official guidance.
• Litigation and Legal Requests :
• Coordinate document requests from outside counsel for litigation matters.
• Database Management :
• Maintain databases related to provider credentials and other essential information.
• Policy Development :
• Draft policies, procedures, manuals, and plan materials.
• Team Oversight :
• Provide oversight and supervision of department staff.

• Juris Doctorate Required
• Minimum 3 years of experience in managed care contracting, credentialing, and compliance.
• Strong knowledge of MLTC, MAP, Medicaid, and Medicare programs.
• Commensurate supervisory experience.
• Ability to review and analyze legal and commercial terms of agreements.
• Proficient in investigating incidents and recommending solutions.
• Highly skilled in organizational management, attention to detail, and multitasking.
• Excellent writing, editing, and proofreading skills.

• $150,000 - $165,000 annually

• Benefits include health insurance, retirement plans, paid time off, and professional development opportunities.

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description JOB SUMMARY This will person will be a Regulatory liaison between product development and the regulatory agencies. This position will be responsible for regulatory submissions for new ANDAs and any changes being made to existing products. The position will also assist in labeling for new products, changes to labeling for existing prescription and OTC products. This position will also interact with other departments and cross functional teams both in US and India. DUTIES & ESSENTIAL JOB FUNCTIONS • Regulatory support of new and existing products including the preparation of ANDAs, supplements, Annual Reports, and responses to FDA deficiency letters/information requests.• Independently manage preparation (in paper or electronic formats (eCTD and SPL)), submission and monitoring progress of FDA review of ANDA's• Communication with functional groups for coordination and preparation of data for submission to FDA• Manage all Regulatory, Federal and State License requirements• Review change controls for regulatory requirements and according to appropriate regulations and guidance’s.• Familiar with Regulatory regulations (e.g. FDA guidance, ICH, 21 CFR etc)• Review labels as per FDA guidance• Regulatory support in drug listing.• Perform other duties as assigned Qualifications QUALIFICATIONS • BS or MS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy• 1 - 2 years’ experience in pharmaceutical regulatory affairs (mandatory)• Attention to detail• Excellent oral and written communication skills• Knowledge of US drug regulatory requirements (mandatory) REQUIRED BS or MS in Sciences or Pharmacy PREFERRED Experience with eCTD filingsRegulatory Affairs Certification (RAC) Additional Information For more information contact me at #J-18808-Ljbffr

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• Prepare, review, and submit regulatory documents to FDA.
• Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.
• Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards.
• Provide regulatory guidance to R&D team during product development life cycle.
• Stay updated on changes in regulatory requirements and communicate potential impacts to the organization.
• Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways.
• Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines.
• Represent the company in meetings with regulatory agencies and external partners as needed.
• Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies.
  
  

• Prepare, review, and submit regulatory documents to FDA.
• Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.
• Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards.
• Provide regulatory guidance to R&D team during product development life cycle.
• Stay updated on changes in regulatory requirements and communicate potential impacts to the organization.
• Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways.
• Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines.
• Represent the company in meetings with regulatory agencies and external partners as needed.
• Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies.
  
  

• Master's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred.
• Minimum of 7-10 years of experience in regulatory affairs within the medical device industry.
• Proven track record of leading and successfully obtaining 510(k) and De Novo clearances/approvals.
• Experience in interacting with FDA and other regulatory agencies.
• In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations.
• Strong leadership and project management skills, with the ability to manage multiple projects and priorities.
• Excellent communication, negotiation, and problem-solving skills.
• Ability to work collaboratively in a cross-functional team environment.
• Detail-oriented with strong organizational skills.

• Seniority level Mid-Senior level

• Employment type Contract

• Job function Legal
• Industries Pharmaceutical Manufacturing

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Allendale, NJ $215,000.00-$30,000.00 2 weeks ago

Whippany, NJ 169,865.00- 254,798.00 6 days ago

Newark, NJ 270,000.00- 340,000.00 1 day ago

New York City Metropolitan Area 175,000.00- 200,000.00 1 week ago

Bronx, NY 180,000.00- 200,000.00 2 weeks ago

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Be the Expert Behind Life-Changing Therapies - Join Us as a Process Expert!

Location: Onsite in Millburn, NJ | Shift: Monday-Friday, 9:00 AM - 5:30 PM

Pay Range: $35.71 - $9.29/hour

At PDS Tech Commercial , we're partnering with a leading name in Pharmaceutical Manufacturing to deliver innovation and excellence in Radioligand Therapy (RLT) . We're searching for a Process Expert who's ready to make an immediate impact-ensuring top-tier quality and compliance on the shop floor of a high-tech, purpose-driven production environment.

Make a Difference Where Precision Matters

As a Process Expert , you'll be a key player in supporting the execution of clinical and commercial batch manufacturing. You'll own deviation investigations, drive continuous process improvements, and play a central role in maintaining regulatory compliance-all while fostering a culture of collaboration and accountability.

What You'll Do:

• Lead timely and thorough investigations of process deviations, including Out of Specification (OOS) and Out of Expectation (OOE) results

• Collaborate across departments to determine root causes and assess impact

• Initiate and monitor CAPAs, ensuring implementation and effectiveness

• Serve as change manager for manufacturing change controls to support process and quality improvements

• Escalate critical issues per company procedures and clearly communicate findings and resolutions

• Draft and review GMP-compliant manufacturing documentation

What You Bring:

Required:

• Bachelor's degree (science or related discipline preferred)

• At least 1 year of GMP experience in a manufacturing setting

• Familiarity with pharmaceutical production processes

• Solid understanding of deviation and CAPA management

• Proficiency in technical writing and regulatory documentation

• Strong communication skills and the ability to work cross-functionally

Preferred:

• Experience in radiopharmaceuticals or sterile drug manufacturing

• Lean/Six Sigma or continuous improvement training/certification

Why Join Us?

At PDS Tech Commercial, you're not just another contractor-you're a valued team member. We partner with innovative companies where your work fuels meaningful change. In this role, you'll be part of a fast-paced environment where your expertise helps deliver therapies that matter . We offer competitive pay, consistent weekday hours, and the opportunity to grow your career in one of the most impactful areas of pharma manufacturing.

Join a Military Friendly® Employer committed to supporting veterans and service members

Apply Today - Build a Career That Makes a Difference

Ready to lead from the floor and make a measurable impact in the world of pharmaceutical innovation?

Apply now to become a Process Expert in Millburn, NJ!

Pay Details: $ 5.71 to 39.29 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance