- Johns Hopkins Medicine (Washington, DC)
- …sterile compounding processes and hazardous drug program to ensure compliance with regulatory standards (TJC, CMS, USP 797 and 800). Manages the staffing, ... care practitioners. In collaboration with Director of Pharmacy, Clinical Operations Manager counterpart, Clinical Pharmacy Manager and Informatics Pharmacist,… more
- Indotronix International Corporation (Allentown, PA)
- Regulatory Compliance Specialist II | Allentown, Pennsylvania, United States This position is for a Regulatory Programs Specialist. Please ensure this title ... by policies and procedures. This position receives guidance and oversight from manager . Typically, does not perform the work being supervised. Manages and… more
- Celularity Inc. (Florham Park, NJ)
- …with regulatory requirements and industry standards. The Sterility Assurance Manager will lead a team of professionals to conduct microbiological testing, ... following: Develop and implement sterility assurance programs, policies, and procedures in compliance with regulatory guidelines (eg, FDA, EMA). Directly lead… more
- Sutter Health (Modesto, CA)
- …TJC. A broad knowledge base of post-acute levels of care and associated regulatory compliance requirements. General understanding of coding and DRG assignment ... This position works in collaboration with the Physician, Utilization Manager , Medical Social Worker and bedside RN to assure...Safety and Health (NIOSH) and in accordance with the USP 800 guidelines. Sutter Health is an equal opportunity… more
- Hims and Hers Health, Inc. (New Albany, OH)
- …ensure compliance with FDA regulations, state regulations,cGMP standards, and USP requirements within a 503B outsourcing facility. This role focuses on managing ... System (QMS) to ensure compliance with 21 CFR Parts 210/211, 503b guidance, USP <797>, <800>, and ISO 14644. Oversee the review and approval of batch records,… more
- Cedent (Houston, TX)
- …review, and approve critical documentation, including protocols, reports, and regulatory submission sections, ensuring compliance with industry standards ... seeking a passionate and dedicated Manufacturing and Process Development Manager to be part of our dynamic team at...written. * Regulatory Expertise: In-depth knowledge of relevant regulatory guidelines (eg, FDA, USP ) for wellness… more
- Vertex Pharmaceuticals (Boston, MA)
- Job Description General Summary: The Manager of Quality Control will be responsible for supporting the oversight of QC external contract labs. The position will ... stability activities in support of clinical and commercial programs, while ensuring compliance with SOP's, policies and industry guidances. In addition, this role… more
- EctoHR, Inc. (Ypsilanti, MI)
- …its patients. Some key responsibilities include sterile and non-sterile compounding, ensuring USP compliance , and processing and packing orders. Perks of Working ... applicable laws and regulations Collaborating with the pharmacy team and Materials Manager on the procurement of drugs and supplies Assessing inventory needs and… more
- Sutter Health (San Francisco, CA)
- …staff committees as assigned to achieve integrated services. *Ensures comprehensive regulatory compliance , demonstrating that the facility maintains full ... accordance with hospital and department policies and procedures and regulatory requirements. *Evaluates workload and adjusts staffing to maintain...accreditation and compliance with state and federal regulations. *Assigns and edits… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …donation/stakeholder engagement (including sales) experience a plus. + Experience with regulatory compliance , quality control, quality assurance or GMP ... **Description** **Who is USP ?** The US Pharmacopeial Convention ( USP )...Ingredients, Excipients, and Active Pharmaceutical Ingredients. The Market Development Manager will be required to cultivate relationships with Industry… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based ... **Description** **Who is USP ?** The US Pharmacopeial Convention ( USP )...support departmental quality initiatives. This position reports to the Manager and interacts on a regular basis with other… more
- Beth Israel Lahey Health (Westwood, MA)
- … <797>, and USP <800> as well as federal and state regulatory compliance requirements **Preferred Qualifications:** 1. Bachelor's Degree 2. Hazardous Drug ... USP standards as well as Federal and State regulatory requirements. **Job Description:** **Pharmacy Technician BILH Systemwide Compounding Specialist Hybrid… more
- West Pharmaceutical Services (Exton, PA)
- …combination products and devices + Devise solutions to close or bridge any compliance gaps through regulatory change to existing programs + Identify fixturing ... Validation Manager , CCI Requisition ID: 70541 Date: Jul 1,...and capabilities. This role will also support in ensuring compliance to established and legacy programs withing the container… more
- Curia (Albuquerque, NM)
- Manager , Microbiology in Albuquerque, NM Build your future at Curia, where our work has the power to save lives Curia is a global contract development and ... matching contributions + Learning platform + And more! Summary The Microbiology Manager is responsible for overseeing the daily operations of the Microbiology… more
- Trinity Health (Westerville, OH)
- …of operational policies and standard work instructions + Assists with monitoring regulatory compliance (quality assurance, safety, USP 797/800, ... daily operations, and collaborate closely with the Clinical Pharmacy Manager to innovate and expand the program. This is...of readying room temperature and pressure monitors for Environment Compliance in accordance with USP Chapters <797>… more
- Element Materials Technology (Concord, CA)
- …provided fit its purpose and meets customer expectations at Element Concord. The Manager 's main duties are to ensure compliance and accuracy when reporting ... services that adhere to the quality management system, client requirements, and regulatory requirements as applicable ie ISO/IEC 17025:2017, USP , GMP, FDA,… more
- Integra LifeSciences (Princeton, NJ)
- …endotoxin-related risks from both a product and patient safety perspective. ** Regulatory Compliance & Documentation:** + Ensure thorough documentation and ... + Detail-oriented with a commitment to maintaining high-quality standards and regulatory compliance . + Experience with quality management systems (QMS)… more
- Kerry (Rothschild, WI)
- …ensures that all products meet the highest standards of quality, safety, and compliance with regulatory and customer requirements. The ideal candidate will have ... beverage and pharmaceutical industries and we are hiring a Sr. Quality Assurance Manager to support our growing business. Based in Rothschild, WI, the Sr. Quality… more
- Cardinal Health (Mansfield, MA)
- …and validation/verification protocols and reports. + Possesses significant working knowledge of USP , FDA and ICH regulatory requirements as applicable to ... for pharmaceutical products of Cardinal Health. Under the umbrella of Quality, Regulatory & Medical Affairs (QRMA), Chem Services develops and executes test… more
- Lilly (Indianapolis, IN)
- …reports, forms, and certificates of analysis. + Interact with auditors and regulatory inspectors. Compliance responsibilities such as: + Assure adherence to ... patients. Lilly RLT is currently searching for an Analytical Chemistry Laboratory Manager . The Analytical Chemistry (AC) Manager ensures laboratory readiness to… more
