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Compliance Specialist jobs at MMS - 145 jobs

  • Recertification/Compliance Specialist

    Mms Group 4.7company rating

    Compliance specialist job at MMS

    Are you an experienced Recertification/Compliance Specialist ready to join our fantastic team of professionals? MMS Group is on the hunt for someone like YOU! As a Recertification/Compliance Specialist, you will be responsible for qualifying new residents for occupancy and requalifying existing residents for continued occupancy. This role demands organization and great attention to detail. Your daily tasks will include conducting interviews, processing paperwork, interacting with various vendors and agencies, and assisting with administrative and leasing tasks to keep the management office running smoothly. The Recertification/Compliance Specialist must proficiently multitask within specific time constraints. MMS Group is seeking an experienced Recertification/Compliance Specialist for a residential property located in Hempstead, NY. Pay Rate: $75,000.00/yearly Key Responsibilities: Maintain Waiting List: Keep the property waiting list current. Applicant Interviews: Conduct interviews with applicants and determine their eligibility. Data Collection: Coordinate on-site data collection and process resident information. Resident Interviews: Schedule resident recertification interviews. Income and Rent Calculation: Ensure accurate calculation of income, assets, and rent levels. Compliance Approval: Seek and obtain Compliance Department approval for new move-ins and selected recertifications. Move-In/Move-Out Coordination: Collaborate with maintenance staff to ensure timely move-in/move-out of residents. Apartment Inspections: Coordinate apartment inspections for recertifications. File Maintenance: Maintain resident files in accordance with company and regulatory agency policies. Office Assistance: Assist office staff with various tasks, including social media marketing. Additional Duties: Perform other duties outlined in the job description. Desired Skills: Independence: Capable of working in a challenging environment with minimal direction. Problem-solving: Solution-oriented thinking skills are highly valued. Organizational Skills: Ability to work independently, organize tasks, manage time, and prioritize projects. Communication: Excellent verbal and written communication and interpersonal skills Confidentiality: Ability to maintain the confidentiality of tenants and management company Teamwork: Ability to work harmoniously with other employees Cultural Sensitivity : Ability to work professionally with diverse ethnic and low-income families Technical Literacy: Ability to read and understand technical documentation such as federal housing regulations and associated policies and procedures Requirements: Experience: Three+ years of low-income, senior, or housing-related programs Education: Associate degree in Marketing and/or Business, preferred. Knowledge: rental assistance and affordable housing programs Certifications: COS, TCS, MORS, BOS, CMH, or AHM (preferred) Software Proficiency : Experience with RealPage OneSite or similar property management software. Computer Skills: Proficient in Microsoft Office (Word, Excel, Outlook). About Us: For fifty years, MMS Group and its affiliates (Arco Management and TUC Management) have been dedicated to quality property management. Our growing portfolio exceeds 40,000 residential units and includes affordable housing cooperatives, subsidized rental properties, supportive housing, and conventional apartment buildings. Our clients include progressive building owners, governmental agencies, real estate entrepreneurs, financiers, not-for-profit organizations, and cooperative and condominium boards. While each community and client are unique, each share our singular commitment to excellence. Why join our Team? We invite you to join our growing team of dedicated professionals in a high-tech environment. We offer competitive salaries, benefits, and opportunities for growth and advancement through continuous training and education programs. ?Contact us today to see how you can achieve your MMS Edge. Perks and Benefits: MMS Group believes in a healthy work-life balance. Keeping our employees in mind, here is a list of a few benefits we offer: Paid Holidays : 12 paid holidays per year. Paid Time-Off: Up to 2 weeks PTO in the first year, increasing with tenure. Healthcare Plans: Comprehensive Medical, Dental, and Vision plans available after 60 days of employment. Health Reimbursement Account: Up to $3K per calendar year. Life Insurance: Company-paid life insurance. Retirement Savings: Company-matched 401(k) retirement savings plan. Certifications and Licensing: Company-paid certifications and licensing. And much more! Are you the person we're looking for? Apply now. Visit us at **************** for more details! Equal Opportunity Employer #INDNE
    $75k yearly Auto-Apply 52d ago
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  • Oncology Specialist - RLT - Austin, Texas

    Novartis Group Companies 4.9company rating

    East Hanover, NJ jobs

    #LI-Remote This is a field-based and remote opportunity supporting key accounts in Austin, Abilene, Bryan College Station, Midland/Odessa, Temple, Waco and the surrounding area. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. Company will not sponsor visas for this position. As the Radioligand Therapy Oncology Specialist (RLT), you'll drive demand creation and develop, coordinate, and implement strategic business plans focused on referral and treatment networks of prostate (primary) and neuroendocrine tumor (secondary) customer accounts to further the Radioligand Therapy (RLT) platform for both the diagnostic and therapeutic portfolio. Your focus will be on driving clinical dialog in a sophisticated, multi-stakeholder healthcare professional environment including engagement, coordination, and planning. You will be a partner with Medical Oncologists, Urologists, Nuclear Medicine, and Radiation Oncologists. Job Description Key Responsibilities: Responsible for business ownership of prescribing and referring physicians, while driving relationships and creation and execution of business plans for territories to include delivery of disease education on diagnostic and therapeutic, product value propositions, treatment protocols and implementing customer programs as appropriate. Support product access, implement competitive response/pull-through strategies, maintain and grow key relationships with account partners in line with defined target priorities in a manner consistent and compliant with company policies and requirements. Develop and employ customized tools and strategies to gain appropriate access to engage with HCP targets within territory accounts to deliver clinical value proposition and establish RLT as the partner of choice in community hospital, academic hospitals, and community oncology accounts. Display an elevated level of self-awareness, a passion for learning, an ability to inspire those around you, a willingness to challenge the status-quo and embrace change to optimize execution. Embody a high-level of confidence to deliver messages in a clear and compelling way to customers, optimally handle objections, and close every call with a commitment to action to inspire changes in behavior. Continuously demonstrate deep understanding of territory market landscape, competitors, market segments / dynamics, product, clinical data, and anticipate environmental changes and challenges to optimize execution. Develop and execute a call-plan to achieve goals and improve access and sales opportunities, while promoting a highly technical and innovative product portfolio to a sophisticated audience. Comfort in using sales data reporting tools to understand trends and coupling with customer insights to identify territory and customer growth opportunities in a constantly evolving environment. Essential Requirements: Bachelor's degree required, advanced degree a plus. 3+ years' experience in specialty pharmaceuticals, biotech, or a sales role of similar complexity within the last 5 years. 1+ years' experience in oncology, urology, nuclear medicine, medical devices, or complex therapeutics. 1+ years' experience in prostate, NET or buy-and-bill therapeutic experience, within last 5 years. Strong ability to collaborate, work cross-functionally within a matrix environment, can communicate clinical product information, has a validated track-record of consistent high-performance, and is proficient in navigating and successfully selling to large accounts and key customer segments. Self-starter with analytic abilities to seek out, prioritize, and apply relevant information to solve problems to meet the needs of key customers, while also demonstrating ethical leadership and ability to champion an environment that promotes ethical behavior and compliance with company policies & laws. Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from the territory border. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license. Desirable Requirements: Experience with multiple product launches. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to . For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week. Novartis Compensation Summary: The salary for this position is expected to range between $151,200 and $226,800 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $145,600.00 - $270,400.00 Skills Desired Accountability, Account Management, Commercial Excellence, Competitive Intelligence, Compliance, Crm (Customer Relationship Management), Customer Engagement, Ethics, Healthcare Sector, Market Development, Problem Solving Skills, Process Knowledge, Revenue Growth, Selling Skills, Team Collaboration, Value Propositions
    $151.2k-226.8k yearly 6d ago
  • Specialist, CAPA I

    Abbvie 4.7company rating

    North Chicago, IL jobs

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (******************************* . Job Description Purpose: Performs root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for drug product manufacturing and packaging. Responsibilities: + Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements + Coordinates the exception document process and creates exception documents + Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions + Ensures all investigations are written according to corporate and site requirements + Participates in implementation and maintenance of the Quality System to meet all applicable regulatory requirements + Effectively collaborates/partners with other Quality areas and departments within the plant Qualifications + Bachelor's degree, preferably in one of the following areas: Biology, Chemistry or Engineering + 4+ years of experience in the pharmaceutical industry in Manufacturing, Quality or Engineering + Ability to problem solve and utilize analytical skills + Knowledge of Quality/Compliance management, Regulations and Standards Leveling will be commensurate to experience. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. + This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* Salary: $64,000 - $122,000
    $64k-122k yearly 2d ago
  • Oncology/Hematology Specialist, Denver South

    Incyte Corporation 4.8company rating

    Wilmington, DE jobs

    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function): The Oncology/Hematology Specialist, Denver South acts as primary customer contact for demand creation by executing the marketing strategy and promoting products. Essential Functions of the Job (Key responsibilities): The willingness and ability to travel as required, with accommodations available for individuals with disabilities. Engage with customers through various channels, including in-person at their offices, virtually, or as requested, ensuring accessibility and inclusivity for all individuals. Execute on marketing strategies, deliver branded sales messages and disease state education, execute planned promotional programs. Represent in a professional, compliant, and ethical manner. Provide feedback on marketing tools and tactics and effectiveness reviews of sales activities. Utilize team members to address customer needs and ensure access to Incyte products for patients who need them. Provide exceptional customer service through total account management, which includes ensuring product access and triaging all medical or reimbursement issues. Execute on marketing strategies, deliver branded and disease state sales messages, execute planned promotional programs. Demonstrate and communicate to external stakeholders in depth knowledge of the clinical benefits of Incyte's products. Develop and maintain strong disease state knowledge and exemplary selling skills. Create and maintain a strategically developed business plan that reflects in depth local market and account specific knowledge. Consistently achieve or exceed revenue targets. Qualifications (Minimal acceptable level of education, work experience, and competency) Local Oncology market knowledge. Customer centric selling approach. Possession of a valid driver's license and a satisfactory driving record, or the ability to obtain one if required for the role. Demonstrate ability to work effectively in matrix teams. Demonstrate ability to gain consistent access and develop strong professional relationships with health care providers in community and academic settings. History of successful sales performance documented in annual reviews and sales reports. Demonstrate strong business analytics and account management skills. Minimum of relevant experience in the Hematology/Oncology market, with a preference for experience in hematology. Minimum of several years of successful biotech/pharmaceutical sales experience, or equivalent relevant experience. A bachelor's degree or equivalent experience is preferred. The ability to travel is required using various modes of transportation (car, air, train, etc.). The level and frequency of travel, including overnights, will depend on the specific territory and/or business purpose or need. We encourage applications from individuals with disabilities and will provide reasonable accommodations to support travel requirements. Demonstrated leadership capabilities, welcoming diverse perspectives and fostering an inclusive team environment. Product 'access' knowledge. Strong communication skills, including the ability to engage with diverse audiences. Strong business planning acumen. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact if you have any questions or concerns or would like to exercise your rights.
    $86k-113k yearly est. 3d ago
  • Onboarding Specialist

    Octapharma Plasma, Inc. 3.8company rating

    Charlotte, NC jobs

    Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role: Onboarding Specialist This Is What You'll Do: Plan and coordinate the logistics of new employee onboarding, including scheduling and preparing materials. Conduct orientation sessions to introduce new hires to the company's culture, values, policies and procedures. Schedule and coordinate onboarding activities, providing guidance and support to new hires throughout the process. Ensuring completion of paperwork and following all legal and administrative compliance when onboarding candidates. Assist new hires with completing the necessary paperwork, including employee forms, benefits enrolment, and IT setup. Processes I-9 and E-Verify requests. Processes background checks and drug screens. This Is Who You Are: Excellent interpersonal skills, strong written and verbal communication skills. Highly ambitious and ability to think outside of the box. Eager to share new ideas and contribute to a team. Self-motivated and willing to assume the initiative. Attentive to every detail. Capable of thriving while working independently. This Is What It Takes: 2+ years of experience in onboarding and recruitment with a proven track record of successful onboarding processes and employee retention. Strong knowledge of onboarding best practices, HR policies and procedures, and employment laws and regulations to ensure compliance during the onboarding process. Strong organizational skills to manage and streamline the onboarding process efficiently. Excellent communication and interpersonal skills to build rapport with new employees and establish a positive onboarding experience. Attention to detail and organizational skills to coordinate and manage multiple onboarding processes simultaneously. Adaptability and flexibility to accommodate the diverse needs and backgrounds of new employees. Ability to collaborate and work effectively with remote team members with prior experience in corporate onboarding. Proficiency in Microsoft Office Suite. Proficiency in using HRIS systems and experience with different applicant tracking systems. May require travel to assist field locations with recruitment. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. INNER SATISFACTION. OUTSTANDING IMPACT.
    $33k-58k yearly est. 5d ago
  • Equine Specialist

    Zoetis, Inc. 4.9company rating

    Houston, TX jobs

    States Considered: Texas Role Description The US Equine business focuses on delivering maximum value to customers through portfolio solutions and strong partnerships. Zoetis provides more than medicines and services-we support customers through: A direct sales field force Aligned technical services teams Valueadded solutions that differentiate us from competitors The Equine Specialist manages the Zoetis Equine business with distributors, veterinarians, dealers, and horse owners within the assigned territory. A strong understanding of the equine market and its dynamics is highly advantageous. This role requires travel and overnight stays. Position Responsibilities Call on Equine and Mixed Animal Veterinarians, Dealers, and Distributor Representatives Quantify and qualify differences among Zoetis products and competitor products Utilize strong presentation skills to conduct educational training and producer seminars Build relationships and influence within key trade channels, including: Veterinarians Distributors OTC dealers Farm personnel University personnel Work closely with Equine distribution partners to drive sales results Manage a broad geographic area with a diverse customer base to achieve sales targets and business objectives Build trust with customers through reliability, credibility, and consistent followup Conduct territory planning and priority setting through data analysis, resource utilization, and execution of business plans Maintain technical and commercial knowledge, including: General equine industry knowledge Indepth Zoetis product knowledge Business and financial acumen of the local customer base Demonstrate teamwork by sharing, collaborating, and acting as a team player Perform other duties and responsibilities as assigned Education & Experience Undergraduate degree (BS/BA) required; equivalent experience considered A master's in Animal Science or a related field is a plus Minimum experience requirements: Associate Equine Specialist: 6+ months of equinerelated experience Equine Specialist: 2+ years of equinerelated experience Senior Equine Specialist: 8+ years of equinerelated experience Animal health experience and equine industry knowledge preferred Ability and willingness to travel overnight at least 50% of the time, including some weekends Technical Skill Requirements Indepth product and disease knowledge Excellent written and oral communication skills Proficiency in PowerPoint, Excel, and Word Physical Position Requirements Valid driver's license required Willingness to drive to customer locations across the defined geography (horse, clinic, and dealer facilities) Ability to work on equine farms Willingness to work with animals, including husbandry, treatment administration, and product administration education Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis 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. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $93k-123k yearly est. 5d ago
  • Regulatory Manager

    Precision Medicine Group 4.1company rating

    Remote

    The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function. Essential functions of the job include but are not limited to: Provides regulatory guidance throughout the clinical development life cycle Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications. Also provides strategic regulatory input as required. Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers Works within a project team, and where necessary, leads project for the region or globally Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. Assist in development of Regulatory Affairs Specialists and other operational area staff, as required Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions. Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval Provides ICH GCP guidance, advice and training to internal and external clients Serve as representative of Global Regulatory Affairs at business development meetings Qualifications: Minimum Required: Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline Computer literacy (MS Office/ Office 365) Fluent in English Preferred: Graduate, postgraduate Possesses basic understanding of financial management Other Required: 5 + years or more relevant regulatory affairs experience Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development Availability for domestic and international travel including overnight stays Competencies Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment Motivates other members of the project team to meet timelines and project goals Flexible attitude with respect to work assignments, and new learning Resolves project related problems and prioritize workload to meet deadlines with little support from management Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective Collects data of consistently high standard Communicates both verbally and in written form in an acceptable manner Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$106,000-$151,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
    $106k-151k yearly Auto-Apply 1d ago
  • Compliance Specialist IV

    J&J Family of Companies 4.7company rating

    New Brunswick, NJ jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Customer Management **Job Sub** **Function:** Non-Technical Customer Service **Job Category:** Professional **All Job Posting Locations:** New Brunswick, New Jersey, United States of America **Job Description:** **Employer:** Johnson & Johnson Health Care Systems Inc. **Job Title:** Compliance Specialist IV **Job Code:** A011.7404.7 **Job Location:** New Brunswick , NJ **Job Type:** Full-Time **Rate of Pay:** $134,000 - $148,000/year **Job Duties:** Develop, execute, and oversee Quality and Compliance (Q&C) programs for Med Tech US field inventory within the North America Region, including Field Inventory Locations (FIL), Field Sales Offices, Loaner Sites, and Distribution Centers (DC). Support "last mile" delivery of surgical loaner sets support joint reconstruction and orthopedic customers across the US. Serve as a liaison with Quality, Distribution, Sales, Commercial, and Supply Chain partners on distribution quality related matters to drive timely resolution of quality related issues. Identify and support implementation of improvement opportunities consistent with business objectives and the Enterprise Quality Standards. Define, implement, and validate quality requirements and systems in alignment with departmental strategies. Participate in and lead audits, inspections, investigations, and remediation activities. Ensure the Quality program maintains regulatory compliance. Provide quality support for existing and new distribution processes. Develop, implement, and review standard operating procedures. Establish and maintain relationships with NA DELIVER, DePuy Synthes Sales Inc., and other Med Tech Franchise customers in order to solve problems and meet changing competitive and regulatory environments. Execute and improve systems/processes in Inspection readiness; Commercial Quality including field inventory consignment and Loaner programs; Process changes; Validation, Calibration, and Preventive Maintenance systems; Delivery service issue trending; and Nonconformance investigation and corrective action plan development, implementation, and effectiveness monitoring. **Requirements:** Employer will accept a Bachelor's degree in Engineering, Life Sciences, or related field and 6 years of experience in the job offered or in a Compliance Specialist IV-related occupation. *May telecommute. *Up to 20% domestic travel required. This job posting is anticipated to close on **2/16** **/2026.** Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: + Vacation -120 hours per calendar year + Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year + Holiday pay, including Floating Holidays -13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year + Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child + Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year + Caregiver Leave - 80 hours in a 52-week rolling period10 days + Volunteer Leave - 32 hours per calendar year + Military Spouse Time-Off - 80 hours per calendar year + This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement. + For additional general information on Company benefits, please go to: - ********************************************* **Required Skills:** **Preferred Skills:**
    $134k-148k yearly 16d ago
  • Compliance Specialist IV

    Johnson & Johnson 4.7company rating

    New Brunswick, NJ jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Customer Management Job Sub Function: Non-Technical Customer Service Job Category: Professional All Job Posting Locations: New Brunswick, New Jersey, United States of America Job Description: Employer: Johnson & Johnson Health Care Systems Inc. Job Title: Compliance Specialist IV Job Code: A011.7404.7 Job Location: New Brunswick , NJ Job Type: Full-Time Rate of Pay: $134,000 - $148,000/year Job Duties: Develop, execute, and oversee Quality and Compliance (Q&C) programs for Med Tech US field inventory within the North America Region, including Field Inventory Locations (FIL), Field Sales Offices, Loaner Sites, and Distribution Centers (DC). Support "last mile" delivery of surgical loaner sets support joint reconstruction and orthopedic customers across the US. Serve as a liaison with Quality, Distribution, Sales, Commercial, and Supply Chain partners on distribution quality related matters to drive timely resolution of quality related issues. Identify and support implementation of improvement opportunities consistent with business objectives and the Enterprise Quality Standards. Define, implement, and validate quality requirements and systems in alignment with departmental strategies. Participate in and lead audits, inspections, investigations, and remediation activities. Ensure the Quality program maintains regulatory compliance. Provide quality support for existing and new distribution processes. Develop, implement, and review standard operating procedures. Establish and maintain relationships with NA DELIVER, DePuy Synthes Sales Inc., and other Med Tech Franchise customers in order to solve problems and meet changing competitive and regulatory environments. Execute and improve systems/processes in Inspection readiness; Commercial Quality including field inventory consignment and Loaner programs; Process changes; Validation, Calibration, and Preventive Maintenance systems; Delivery service issue trending; and Nonconformance investigation and corrective action plan development, implementation, and effectiveness monitoring. Requirements: Employer will accept a Bachelor's degree in Engineering, Life Sciences, or related field and 6 years of experience in the job offered or in a Compliance Specialist IV-related occupation. * May telecommute. * Up to 20% domestic travel required. This job posting is anticipated to close on 2/16/2026. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: * Vacation -120 hours per calendar year * Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year * Holiday pay, including Floating Holidays -13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year * Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child * Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year * Caregiver Leave - 80 hours in a 52-week rolling period10 days * Volunteer Leave - 32 hours per calendar year * Military Spouse Time-Off - 80 hours per calendar year * This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement. * For additional general information on Company benefits, please go to: - ********************************************* Required Skills: Preferred Skills:
    $134k-148k yearly Auto-Apply 16d ago
  • Compliance Specialist IV

    Johnson & Johnson 4.7company rating

    Brunswick, OH jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Customer Management Job Sub Function: Non-Technical Customer Service Job Category: Professional All Job Posting Locations: New Brunswick, New Jersey, United States of America Job Description: Employer: Johnson & Johnson Health Care Systems Inc. Job Title: Compliance Specialist IV Job Code: A011.7404.7 Job Location: New Brunswick , NJ Job Type: Full-Time Rate of Pay: $134,000 - $148,000/year Job Duties: Develop, execute, and oversee Quality and Compliance (Q&C) programs for Med Tech US field inventory within the North America Region, including Field Inventory Locations (FIL), Field Sales Offices, Loaner Sites, and Distribution Centers (DC). Support “last mile” delivery of surgical loaner sets support joint reconstruction and orthopedic customers across the US. Serve as a liaison with Quality, Distribution, Sales, Commercial, and Supply Chain partners on distribution quality related matters to drive timely resolution of quality related issues. Identify and support implementation of improvement opportunities consistent with business objectives and the Enterprise Quality Standards. Define, implement, and validate quality requirements and systems in alignment with departmental strategies. Participate in and lead audits, inspections, investigations, and remediation activities. Ensure the Quality program maintains regulatory compliance. Provide quality support for existing and new distribution processes. Develop, implement, and review standard operating procedures. Establish and maintain relationships with NA DELIVER, DePuy Synthes Sales Inc., and other Med Tech Franchise customers in order to solve problems and meet changing competitive and regulatory environments. Execute and improve systems/processes in Inspection readiness; Commercial Quality including field inventory consignment and Loaner programs; Process changes; Validation, Calibration, and Preventive Maintenance systems; Delivery service issue trending; and Nonconformance investigation and corrective action plan development, implementation, and effectiveness monitoring. Requirements: Employer will accept a Bachelor's degree in Engineering, Life Sciences, or related field and 6 years of experience in the job offered or in a Compliance Specialist IV-related occupation. *May telecommute. *Up to 20% domestic travel required. This job posting is anticipated to close on 2/16/2026. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement. For additional general information on Company benefits, please go to: - ********************************************* Required Skills: Preferred Skills:
    $134k-148k yearly Auto-Apply 15d ago
  • Operations Compliance Specialist

    Catalent Pharma Solutions 4.4company rating

    San Diego, CA jobs

    + **Work Schedule:** Monday-Friday, core hours 8am-4:30pm + 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent's West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution. The Operations Compliance Specialist ensures patient safety, regulatory compliance, and inspection readiness by leading investigations and managing deviations and complaints with precision and accountability. This role facilitates Rapid Response Team fact-gathering, authors clear and comprehensive investigation reports, and proposes effective Corrective and Preventive Actions (CAPAs) to prevent recurrence of quality events. Leveraging industry-standard Lean and Six Sigma tools, the Specialist drives root cause analysis (RCA), leads cross-functional problem-solving sessions, and develops Standard Operating Procedures (SOPs) and work instructions to strengthen operational standards. **The Role:** + Participate in and facilitate Rapid Response Team fact gathering + Write Investigation reports - These written reports will clearly communicate what happened, why it happened, when it happened + Propose CAPAs - how to prevent event from happening in the future. Author SOPs and work instructions + Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events + Review investigation documentation for Out of Spec/Trend (OOS/T) or atypical results, as well as deviations from regulations, corporate policy or site procedures + Manage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner + Facilitate cross-functional problem-solving events. Communicates clearly with internal and external clients, both verbal and written. Use clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks + Other duties as assigned **The Candidate:** + High School Diploma/GED required. Bachelor of Science in Engineering, Pharmaceutical Sciences, or a related field is highly preferred. Lean Six Sigma certification is highly desirable + Minimum of two (2) years of experience with pharmaceutical packaging and distribution processes, Standard Operating Procedures (SOPs) and GxPs + Minimum of one (1) year of experience with technical writing such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GxP environment + Preferred knowledge of systems - JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, EDMS, etc. + Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time. Must be able to communicate effectively with internal and external customers, peers and managers + Physical requirements: able to perform duties which include standing, walking, sitting frequently and significant amount of use of office equipment and computers, keyboards, and writing by hand; Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges occasionally **Pay:** + The anticipated salary range for this role in San Diego, CA is $80,000 to $90,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $80k-90k yearly 52d ago
  • Operations Compliance Specialist

    Catalent 4.4company rating

    San Diego, CA jobs

    Work Schedule: Monday-Friday, core hours 8am-4:30pm 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent's West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution. The Operations Compliance Specialist ensures patient safety, regulatory compliance, and inspection readiness by leading investigations and managing deviations and complaints with precision and accountability. This role facilitates Rapid Response Team fact-gathering, authors clear and comprehensive investigation reports, and proposes effective Corrective and Preventive Actions (CAPAs) to prevent recurrence of quality events. Leveraging industry-standard Lean and Six Sigma tools, the Specialist drives root cause analysis (RCA), leads cross-functional problem-solving sessions, and develops Standard Operating Procedures (SOPs) and work instructions to strengthen operational standards. The Role: Participate in and facilitate Rapid Response Team fact gathering Write Investigation reports - These written reports will clearly communicate what happened, why it happened, when it happened Propose CAPAs - how to prevent event from happening in the future. Author SOPs and work instructions Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events Review investigation documentation for Out of Spec/Trend (OOS/T) or atypical results, as well as deviations from regulations, corporate policy or site procedures Manage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner Facilitate cross-functional problem-solving events. Communicates clearly with internal and external clients, both verbal and written. Use clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks Other duties as assigned The Candidate: High School Diploma/GED required. Bachelor of Science in Engineering, Pharmaceutical Sciences, or a related field is highly preferred. Lean Six Sigma certification is highly desirable Minimum of two (2) years of experience with pharmaceutical packaging and distribution processes, Standard Operating Procedures (SOPs) and GxPs Minimum of one (1) year of experience with technical writing such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GxP environment Preferred knowledge of systems - JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, EDMS, etc. Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time. Must be able to communicate effectively with internal and external customers, peers and managers Physical requirements: able to perform duties which include standing, walking, sitting frequently and significant amount of use of office equipment and computers, keyboards, and writing by hand; Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges occasionally Pay: The anticipated salary range for this role in San Diego, CA is $80,000 to $90,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. Several Employee Resource Groups focusing on Diversity and Inclusion. Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. 152 hours of PTO + 10 paid holidays. Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. Tuition Reimbursement - Let us help you finish your degree or earn a new one! WellHub program to promote overall physical wellness. Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $80k-90k yearly Auto-Apply 16d ago
  • Operations Compliance Specialist

    Catalent Pharma Solutions, Inc. 4.4company rating

    San Diego, CA jobs

    * Work Schedule: Monday-Friday, core hours 8am-4:30pm * 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent's West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution. The Operations Compliance Specialist ensures patient safety, regulatory compliance, and inspection readiness by leading investigations and managing deviations and complaints with precision and accountability. This role facilitates Rapid Response Team fact-gathering, authors clear and comprehensive investigation reports, and proposes effective Corrective and Preventive Actions (CAPAs) to prevent recurrence of quality events. Leveraging industry-standard Lean and Six Sigma tools, the Specialist drives root cause analysis (RCA), leads cross-functional problem-solving sessions, and develops Standard Operating Procedures (SOPs) and work instructions to strengthen operational standards. The Role: * Participate in and facilitate Rapid Response Team fact gathering * Write Investigation reports - These written reports will clearly communicate what happened, why it happened, when it happened * Propose CAPAs - how to prevent event from happening in the future. Author SOPs and work instructions * Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events * Review investigation documentation for Out of Spec/Trend (OOS/T) or atypical results, as well as deviations from regulations, corporate policy or site procedures * Manage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner * Facilitate cross-functional problem-solving events. Communicates clearly with internal and external clients, both verbal and written. Use clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks * Other duties as assigned The Candidate: * High School Diploma/GED required. Bachelor of Science in Engineering, Pharmaceutical Sciences, or a related field is highly preferred. Lean Six Sigma certification is highly desirable * Minimum of two (2) years of experience with pharmaceutical packaging and distribution processes, Standard Operating Procedures (SOPs) and GxPs * Minimum of one (1) year of experience with technical writing such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GxP environment * Preferred knowledge of systems - JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, EDMS, etc. * Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time. Must be able to communicate effectively with internal and external customers, peers and managers * Physical requirements: able to perform duties which include standing, walking, sitting frequently and significant amount of use of office equipment and computers, keyboards, and writing by hand; Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges occasionally Pay: * The anticipated salary range for this role in San Diego, CA is $80,000 to $90,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: * Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. * Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. * Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. * Several Employee Resource Groups focusing on Diversity and Inclusion. * Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. * 152 hours of PTO + 10 paid holidays. * Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. * Tuition Reimbursement - Let us help you finish your degree or earn a new one! * WellHub program to promote overall physical wellness. * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $80k-90k yearly Auto-Apply 15d ago
  • Compliance Specialist

    Children's National Medical Center 4.6company rating

    Silver Spring, MD jobs

    Under general supervision from a Compliance Director, the Compliance Specialist monitors CNHS's adherence to regulatory requirements and organizational policies and procedures. This position will interact with all levels of CNHS stakeholders, including staff, management, leadership, and Boards of Directors. Functional accountabilities include internal investigations, auditing and monitoring activities, and education and training, as well as maintaining data and analytics that report on department operations. The position requires exceptional communication and critical thinking skills, as well as attention to detail, resourcefulness, and a commitment to process improvement. Minimum Education Bachelor's Degree (Required) Minimum Work Experience 5 years Experience in a healthcare compliance role or equivalent experience (Required) Functional Accountabilities Safety * Speak up when team members appear to exhibit unsafe behavior or performance * Continuously validate and verify information needed for decision making or documentation * Stop in the face of uncertainty and takes time to resolve the situation * Demonstrate accurate, clear and timely verbal and written communication * Actively promote safety for patients, families, visitors and co-workers * Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Compliance Management * Ensure sensitive and confidential issues are concisely communicated, resolved, and documented in accordance with applicable legal requirements and organizational policies and procedures. * Assist with implementation of compliance work plan * Develop presentations for the Compliance Management Committee and work groups. * Review and revise compliance policies and procedures on a periodic basis. * Assist Compliance Directors and the Vice President of Compliance with other department activities, as assigned. * Maintain and manage files relating to compliance activities. * Assist Compliance Directors and the Vice President of Compliance with developing and reporting compliance metrics, as needed. Internal Investigations & Reviews * Perform and document internal investigations in accordance with applicable legal requirements and organizational policies and procedures. * Maintain a log of compliance investigations and reviews in accordance with department requirements. Compliance Education & Training * Provide compliance educational and training offerings. * In partnership with the Legal Department, serve as a subject matter resource and provide consultation services regarding the application and implementation of current legal requirements and organizational policies and procedures. * Monitor legal and industry developments and identify opportunities for their application and integration into compliance activities. Auditing & Monitoring * Perform compliance audits and reviews. * Serve as strategic partner to internal stakeholders in the assessment and analysis of audit findings (by internal and external auditors) to determine root causes of issues identified and corrective action plans. Organizational Accountabilities Organizational Accountabilities (Staff) Organizational Commitment/Identification * Anticipate and responds to customer needs; follows up until needs are met Teamwork/Communication * Demonstrate collaborative and respectful behavior * Partner with all team members to achieve goals * Receptive to others' ideas and opinions Performance Improvement/Problem-solving * Contribute to a positive work environment * Demonstrate flexibility and willingness to change * Identify opportunities to improve clinical and administrative processes * Make appropriate decisions, using sound judgment Cost Management/Financial Responsibility * Use resources efficiently * Search for less costly ways of doing things Safety * Speak up when team members appear to exhibit unsafe behavior or performance * Continuously validate and verify information needed for decision making or documentation * Stop in the face of uncertainty and takes time to resolve the situation * Demonstrate accurate, clear and timely verbal and written communication * Actively promote safety for patients, families, visitors and co-workers * Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
    $51k-65k yearly est. 60d+ ago
  • Compliance Specialist

    Children's National 4.6company rating

    Silver Spring, MD jobs

    Compliance Specialist - (250002D9) Description Under general supervision from a Compliance Director, the Compliance Specialist monitors CNHS's adherence to regulatory requirements and organizational policies and procedures. This position will interact with all levels of CNHS stakeholders, including staff, management, leadership, and Boards of Directors. Functional accountabilities include internal investigations, auditing and monitoring activities, and education and training, as well as maintaining data and analytics that report on department operations. The position requires exceptional communication and critical thinking skills, as well as attention to detail, resourcefulness, and a commitment to process improvement. Qualifications Minimum EducationBachelor's Degree (Required) Minimum Work Experience5 years Experience in a healthcare compliance role or equivalent experience (Required) Functional AccountabilitiesSafetySpeak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Compliance ManagementEnsure sensitive and confidential issues are concisely communicated, resolved, and documented in accordance with applicable legal requirements and organizational policies and procedures. Assist with implementation of compliance work plan Develop presentations for the Compliance Management Committee and work groups. Review and revise compliance policies and procedures on a periodic basis. Assist Compliance Directors and the Vice President of Compliance with other department activities, as assigned. Maintain and manage files relating to compliance activities. Assist Compliance Directors and the Vice President of Compliance with developing and reporting compliance metrics, as needed. Internal Investigations & ReviewsPerform and document internal investigations in accordance with applicable legal requirements and organizational policies and procedures. Maintain a log of compliance investigations and reviews in accordance with department requirements. Compliance Education & TrainingProvide compliance educational and training offerings. In partnership with the Legal Department, serve as a subject matter resource and provide consultation services regarding the application and implementation of current legal requirements and organizational policies and procedures. Monitor legal and industry developments and identify opportunities for their application and integration into compliance activities. Auditing & MonitoringPerform compliance audits and reviews. Serve as strategic partner to internal stakeholders in the assessment and analysis of audit findings (by internal and external auditors) to determine root causes of issues identified and corrective action plans. Organizational AccountabilitiesOrganizational Accountabilities (Staff) Organizational Commitment/Identification Anticipate and responds to customer needs; follows up until needs are met Teamwork/Communication Demonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial Responsibility Use resources efficiently Search for less costly ways of doing things Safety Speak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Primary Location: Maryland-Silver SpringWork Locations: Inventa Towers 1 Inventa Place Silver Spring 20910Job: Non-Clinical ProfessionalOrganization: LegalPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: 8:30-5Job Posting: Oct 15, 2025, 8:21:39 PMFull-Time Salary Range: 73070. 4 - 121804. 8
    $51k-65k yearly est. Auto-Apply 4h ago
  • Healthcare Compliance Specialist

    Grifols Sa 4.2company rating

    Raleigh, NC jobs

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Position Overview: The Compliance Specialist supports the North American Healthcare Compliance organization in administration of an effective US healthcare compliance program. He or she will work internally to support compliance processes and procedures. The position can have a US or global scope of work. Responsibilities include but are not limited to: * Support compliance operations, including project reviews and documentation * Support compliance process and procedure development, documentation, and implementation * Support compliance monitoring and auditing program * Participate in and contribute to risk assessment and gap analysis * Assist in the collection, aggregation, analysis and reporting of compliance data to internal and external parties * Investigate and document compliance issues and concerns * Assist in monitoring and implementation of compliance training program * Support development and revision to compliance training * Provide guidance and clarification to customers on compliance policies and regulations * Work collaboratively with compliance colleagues to meet company objectives and serve customers Skills/Qualifications/Education: The requirements below are representative of the knowledge, skills, education and/or ability required. * Bachelor's degree with two years of experience, or equivalent combination of education and experience * Ability to travel 15% primarily within the US * Familiarity with US healthcare compliance laws and regulations preferred * Exposure to US and international commercial operations preferred * Ability to conduct audits with guidance * Strong attention to detail * Ability to issue spot straight forward issues and analyze data for patterns and inconsistencies * Understands how work fits into larger business * Demonstrates leadership skills and interest * Strong interpersonal skills * Strong verbal and writing skills * Ability to communicate effectively * Strong ethics, concern for standards, and desire to help others do the right thing * Ability to perform duties with the highest degree of confidentiality, objectivity, and fairness * Ability to work independently * Understands the purpose and components of presentations and is able to develop presentation and present to a small group * Proficient with standard PC software * Obtains professional development annually, including learnings from outside the company Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws. Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters
    $48k-75k yearly est. 2d ago
  • Quality & Compliance Manager

    GSMS 3.1company rating

    Camarillo, CA jobs

    Quality & Compliance Manager Job Title: Quality & Compliance Manager Job Type: Full-time Job Category: Professional Department/Division: Quality/Operations Created Date: 12/17/2025 Revised Date: NA FLSA Status: Exempt Shift: 1st Experience: Minimum 8+ years in pharmaceutical operations required. High School Diploma required. Bachelor's degree preferred, health sciences preferred. Summary The Quality & Compliance Manager will lead the development, management, and execution of the supplier quality management, internal audit & inspection readiness, and CAPA programs at GSMS. This role is responsible for supplier quality management of suppliers that provide raw materials, drug products, and GMP services to GSMS; the GSMS internal audit and inspection readiness program; and the GSMS CAPA prograom. This role oversees supplier qualification & performance, external & internal audit strategy, compliance with FDA regulations, and CAPA monitoring & effectiveness. General Duties and Responsibilities: Responsible for the development and execution of the supplier quality management program and processes for GMP suppliers. Manage the quality of drug product, raw material, and GMP service suppliers to ensure GSMS and FDA requirements are met Qualify new suppliers per GSMS policies and procedures. Negotiate, approve and manage quality agreements between GSMS and suppliers Participate on a cross functional supplier management team with colleagues from Supply Chain, Purchasing, and Commercial Operations to assess, communicate, and manage supplier performance via scorecards and business meetings Develop and maintain supplier risk ranking including evaluating internal and supplier Preventive Controls Oversee the Supplier Change Notification (SCN) process, ensuring GSMS is notified of supplier changes and GSMS processes & procedures are thoroughly assessed and updated as required. Work collaboratively with suppliers and GSMS Quality teams on Supplier Corrective Action Request (SCAR) process, ensuring effective corrective actions are being taken by suppliers. Develop and maintain a current and accurate database of supplier quality management information such as Supplier History File, Approved Vendor List (AVL), risk analysis results, supplier performance, etc. Develop and manage GSMS external and internal audit programs. Oversee and conduct external and internal audits, ensuring any improvements or corrective actions are addressed to GSMS's satisfaction. Manage GSMS CAPA program. Lead CAPA meetings and monitor timeliness & effectiveness of correction actions. Helps drive a culture of continuous improvement. Assist with leading regulatory and 3 rd party inspections and audits, including pre-inspection readiness, inspection execution, and post inspection responses. Performs other quality and compliance-related duties as assigned. Supervision: Received: Directives from Director, Quality & Regulatory Compliance Given: N/A Equipment: Standard office equipment, computers, safety glasses, cap, booties, gloves, as required. Physical/Cognitive Requirements: Strong knowledge of FDA GMP regulations, practices and trends. Working knowledge of pharmaceutical processing and manufacturing processes. Strong communication skills at all levels, both written and verbal; both individually and in a group setting. Strong leadership, negotiation and influencing skills Strong skills in analytical thinking and problem solving. Proficiency in audit planning, execution, and reporting. Ability to translate complex data into actionable information Ability to evaluate complex compliance issues and concerns Ability to perform multiple tasks and ability to effectively manage conflict. Ability to work in teams to obtain results. Good decision-making skills. Ability to make decisions with limited information. Proactively identify issues and take action. Effectively manage change and comfortable changing direction and acting without complete information. Good organizational and prioritization skills. May be required to work longer than the typical 8-hour work day. Sedentary position that may requires pro-longed long periods of desk work. Requires light physical duties in keeping work areas clean and organized. Regularly required to walk the production and warehouse areas. Computer Skills: Required working knowledge of basic Microsoft Office applications. Working knowledge of data analysis software and reporting. Miscellaneous Requirements: Must be able to pass screening, drug test and background check. Adhere to company's drug-free workplace policies. Travel 25-30% domestic to supplier locations. Attitude: Must be enthusiastic, concerned with job and company as whole, openness with management, and punctual. Self-discipline and a desire to achieve results. Must be detail-oriented. Team player, professional, and achieve high quality results. The hiring range for this position in Camarillo, CA is $85,000 to $115,000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills and experience among other factors. A bonus may be provided as part of the compensation package, in addition to a full range of other health and welfare benefits.
    $85k-115k yearly 8d ago
  • DEA Compliance Specialist

    QuVa Pharma 4.5company rating

    Sugar Land, TX jobs

    Our DEA Compliance Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include managing and coordinating all DEA related activities at the manufacturing site. This person is a subject matter expert on all matters related to DEA compliance in pharmaceutical manufacturing industry, to include the distributing of controlled substances. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. What the DEA Compliance Specialist Does Each Day: * Manages and coordinates all DEA related activities at multiple production facilities * Conducts year end and biennial inventory and report ARCOS quarterly reporting and cycle count inventory via DEA website * Responsible for implementing and gathering data to support YERS inventories * Coordinates all movement of control substances from manufacturing through analytical testing * Trains internal individuals on controlled substance Standard Operating Procedures * Maintains compliance of all DEA, State and Board of Pharmacy registrations * Coordinates all controlled substance destruction with appropriate Quality and Logistics departments * Responsible for all necessary DEA registration and ordering forms (DEA 222) * Responsible for regulatory requirements for CSOS setup and maintenance * Responsible for submitting CII quotas to DEA, maintain organized DEA files on related activities * Coordinates and document DEA audits for sites and issue audit reports to management upon completion * Remains current on DEA regulations in order to address organization business needs Our Most Successful DEA Compliance Specialists: * Are detail-oriented with strong verbal and written communications skills * Express energy, show accountability, and multi-task * Fulfill expectations, establish sustainable relationships with team members, maintain effective and meaningful communication channels * Have a sense of urgency, accountability, and resourcefulness * Are self-starters and independent learners Minimum Requirements for this Role: * Bachelor's degree or equivalent with 5 to 7 years work experience * Able to successfully complete a drug and background check * Expert in DEA manufacturing regulations and requirements * Experience in maintaining DEA compliance systems * Knowledgeable in drug quota management and submissions * Experienced in the workings of the department of justice and DEA for communications * Implementing compliance systems to maintain corporate compliance of all DEA regulations * Knowledge in the security requirements * Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation * Must be currently authorized to work in the United States on a full-time basis; Quva will not sponsor applicants for work visas Any of the Following Will Give You an Edge: * Experience in DEA Compliance or DEA related roles * 2 to 3 years work experience with DEA / Controlled Substances Benefits of Working at Quva: * Comprehensive health and wellness benefits including medical, dental and vision * 401k retirement program with company match * 17 paid days off plus 8 paid holidays per year * Occasional weekend and overtime opportunities with advance notice * National, industry-leading high growth company with future career advancement opportunities About Quva: Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is "at will."
    $46k-73k yearly est. 13d ago
  • Healthcare Compliance Specialist

    Grifols Shared Services North America, Inc. 4.2company rating

    Rex, NC jobs

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Position Overview: The Compliance Specialist supports the North American Healthcare Compliance organization in administration of an effective US healthcare compliance program. He or she will work internally to support compliance processes and procedures. The position can have a US or global scope of work. Responsibilities include but are not limited to: - Support compliance operations, including project reviews and documentation - Support compliance process and procedure development, documentation, and implementation - Support compliance monitoring and auditing program - Participate in and contribute to risk assessment and gap analysis - Assist in the collection, aggregation, analysis and reporting of compliance data to internal and external parties - Investigate and document compliance issues and concerns - Assist in monitoring and implementation of compliance training program - Support development and revision to compliance training - Provide guidance and clarification to customers on compliance policies and regulations - Work collaboratively with compliance colleagues to meet company objectives and serve customers Skills/Qualifications/Education: The requirements below are representative of the knowledge, skills, education and/or ability required. - Bachelor's degree with two years of experience, or equivalent combination of education and experience - Ability to travel 15% primarily within the US - Familiarity with US healthcare compliance laws and regulations preferred - Exposure to US and international commercial operations preferred - Ability to conduct audits with guidance - Strong attention to detail - Ability to issue spot straight forward issues and analyze data for patterns and inconsistencies - Understands how work fits into larger business - Demonstrates leadership skills and interest - Strong interpersonal skills - Strong verbal and writing skills - Ability to communicate effectively - Strong ethics, concern for standards, and desire to help others do the right thing - Ability to perform duties with the highest degree of confidentiality, objectivity, and fairness - Ability to work independently - Understands the purpose and components of presentations and is able to develop presentation and present to a small group - Proficient with standard PC software - Obtains professional development annually, including learnings from outside the company Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws. **Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters** Learn more about Grifols (************************************** **Req ID:** 538663 **Type:** Regular Full-Time **Job Category:** GENERAL MANAGEMENT
    $47k-74k yearly est. 2d ago
  • Compliance Manager - Affordable Property Management

    MMS Group 4.7company rating

    Compliance specialist job at MMS

    Job Description We are looking for a Lease-Up Compliance Manager for our corporate office. The Lease-Up Compliance Manager is responsible for ensuring compliance with federal, state, and local affordable housing regulations during the lease-up phase of new properties. This position plays a critical role in overseeing resident eligibility, coordinating with site teams, and ensuring timely and accurate file approvals. The Lease-Up Compliance Manager serves as a key resource for property management teams, investors, and regulatory agencies. Duties and Responsibilities: Lead the compliance efforts for new lease-ups, ensuring adherence to affordable housing program requirements, including LIHTC, HUD, HOME, and other funding sources. Review, approve, and monitor resident applications, income verifications, and other eligibility documentation to ensure compliance with regulatory requirements. Provide training and support to site teams on lease-up procedures, compliance regulations, and best practices. Collaborate with property managers, regional teams, and external auditors to ensure accurate and timely lease-up execution. Develop and maintain compliance tracking systems to monitor lease-up progress and ensure timely submission of reports. Conduct internal audits of lease-up files to ensure accuracy and compliance with program guidelines. Serve as the primary liaison with housing agencies, syndicators, and investors regarding compliance matters during the lease-up process. Assist in preparing responses to compliance audits and regulatory agency requests. Stay informed on changes in affordable housing regulations and update policies and procedures as needed. Help prepare for internal and external audits by organizing tenant files, ensuring all documentation is up-to-date, and addressing any discrepancies found during preliminary reviews Provide excellent customer service to prospective and current clients, tenants, and representatives of tenants, addressing their inquiries and guiding them through the lease-up process Work closely with the LIHTC Compliance Lead to ensure all leasing activities adhere to IRS Section 42, HUD guidelines and state-specific housing requirements. Help in achieving full occupancy and meet lease up deadlines within all regulatory timelines The lease-up compliance manager may work on multiple projects at one time as directed by the lease-up acquisition Lead Any other related duties as assigned Education and Experience: Minimum 3-5 years of experience in affordable housing compliance, with a strong focus on lease-ups Must have the ability to travel Minimum 2 years of college experience preferred 3 years of compliance/audit experience HCCP, CPO, TCS or equivalent housing certifications, preferred Strong knowledge of LIHTC, HUD, and other affordable housing programs. Experience in reviewing and approving resident eligibility files in accordance with compliance guidelines. Proficiency in property management software and compliance tracking systems. Excellent organizational, communication, and problem-solving skills. Ability to manage multiple projects and meet critical deadlines. OneSite property management software experience preferred Business acumen, cross-functional competence, interpersonal savvy, and strong analytical capabilities Excellent oral and written English skills and strong presentation and command skills About Us: For fifty years, MMS Group and its affiliates (Arco Management and TUC Management) have been dedicated to quality property management. Our growing portfolio exceeds 40,000 residential units and includes affordable housing cooperatives, subsidized rental properties, supportive housing, and conventional apartment buildings. Our clients include progressive building owners, governmental agencies, real estate entrepreneurs, financiers, not-for-profit organizations, and cooperative and condominium boards. While each community and client are unique, each share our singular commitment to excellence. Why join our Team? We invite you to join our growing team of dedicated professionals in a high-tech environment. We offer competitive salaries, benefits, and opportunities for growth and advancement through continuous training and education programs. Contact us today to see how you can achieve your MMS Edge. Perks and Benefits: MMS Group believes in a healthy work-life balance. Keeping our employees in mind, here is a list of a few benefits we offer: Paid Holidays: 12 paid holidays per year. Paid Time-Off: Up to 2 weeks PTO in the first year, increasing with tenure. Healthcare Plans: Comprehensive Medical, Dental, and Vision plans are available after 60 days of employment. Health Reimbursement Account: Up to $3K per calendar year. Life Insurance: Company-paid life insurance. Retirement Savings: Company-matched 401(k) retirement savings plan. Certifications and Licensing: Company-paid certifications and licensing. And much more! Are you the person we're looking for? Apply now. Visit us at **************** for more details! Equal Opportunity Employer
    $91k-143k yearly est. 31d ago

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