- Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates.
- Understanding of how to plan, prepare and conduct GCP audits independently.
- Proficient in authoring and managing audit documents independently.
- Experience in reviewing and editing QMS related documents, i.e., SOPs, Work Practices, Forms, Training Materials, etc. independently.
- Develop CAPA plans and contribute to resolution of audit findings independently.
- Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently.
- Assists in other duties relating to overall compliance within Quality and Compliance department, as requested.
- Must be willing to travel up to 75% of the time for audits within the US and potential travel to Canada. Requirements:
- College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years' experience in GCP regulated industry if not a college graduate
- Minimum of 5 years' experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
- Expert knowledge of scientific principles and concepts.
- Reputation as emerging leader in field with sustained performance and accomplishment.
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Good communication skills and willingness to work with others to clearly understand needs and solve problems.
- Excellent problem-solving skills.
- Good organizational and communication skills.
- Proficient with 21 CFR Part 11, FDA, and GxP requirements.
- Expertise within CROs and scientific and clinical data/ terminology, and the drug development process.
-
IT Compliance Specialist
2 weeks ago
Insight Global Virginia, United StatesInsight Global is looking for an IT Compliance Specialist to support a large client in Richmond, VA. This role is hybrid with one week onsite in downtown Richmond, one week remote. This individual needs to be local to Richmond, VA. · Job responsibilities are listed below: · Revie ...
-
Affordable Housing Compliance Specialist
1 week ago
Premier Property Management Charleston, United StatesJob Title: Affordable Housing Compliance Specialist · Company Overview: Premier Property Management is a leading provider of affordable housing solutions committed to ensuring that everyone has access to safe, secure, and comfortable housing. We specialize in developing, managing ...
-
Accounts Payable Specialist
1 week ago
American Public Education, Inc. Charles Town, United States**Accounts Payable Specialist** · **American Public Education, Inc.** · The Accounts Payable Specialist is responsible for the Accounts Payable processing cycle including and not limited to invoices, expense reimbursements, corporate cards, creating purchase requisitions, respond ...
-
Pa Specialists Supervisor
5 days ago
WellSense Health Plan Charlestown, United StatesIt's an exciting time to join the WellSense Health Plan, a growing regional health insurance company with a 25-year history of providing health insurance that works for our members, no matter their circumstances. · **Job Summary**: · Responsible for the daily supervision and oper ...
-
Velocity Solutions North Charleston, United StatesNorth Charleston System Gastronomy Specialist (m/f/d) 2023 · WHAT TO EXPECT? · Your range of tasks is diverse: both on land in restaurants and on board the AG "EMS" ships, you will learn about the processes in system gastronomy. Guest service, food preparation, and compliance wit ...
-
Market Manager Assistant
2 weeks ago
Radiant Innovations Charles Town, United StatesLocation: Greater Rostock area | Contract type: Full-time/part-time, permanent | Job ID: 838261 · What you'll be doing with us: · As a leader, you want to take on responsibility and contribute to a culture of respectful leadership? Then support the store management in our REWE ma ...
-
Warehouse Control Clerk
2 weeks ago
Apex Dynamics Charleston, United StatesWHAT WE ARE LOOKING FOR · Ensuring production supply · Controlling warehouse logistics processes · Inventory control and clean-up · Contact person for customers in the production sector · Compliance with deadlines, quality and safety standards in the responsible area · WHAT YOU S ...
-
Loan Servicing Specialist Ii
2 days ago
Bank of Charles Town Charles Town, United StatesFull-Time · **Summary**: · Performs administrative tasks to book and service Commercial loans, participations, renewals, and modifications, that contain a variety of complex loan structures. Performs Mortgage Escrow analysis and other various Consumer servicing tasks. All functio ...
-
Peer Support Specialist
1 week ago
BayMark Health Services Charleston, United StatesJob Description · Peer Support SpecialistJOB SUMMARYThe Peer Support Specialist (PSS) will follow best practices to provide behavioral health services that foster supportive peer relationships with and among the persons enrolled in behavioral health services and other related pro ...
-
Travel Nurse
4 days ago
Triage Virginia, United StatesTriage is seeking an experienced General Practice Certified Nursing Assistant for an exciting Travel Nursing job in Virginia, MN. Shift: Inquire Start Date: 05/27/2024 Duration: 13 weeks Pay: $ / Week Travel CNA | Virginia, MN · Travel Nursing: Long Term Care Virginia · Location ...
-
Travel Respiratory Therapist
3 days ago
Triage Charleston, United StatesTriage is seeking an experienced Respiratory Therapist for an exciting Travel Allied job in Charleston, SC. Shift: Inquire Start Date: 06/17/2024 Duration: 13 weeks Pay: $ / Week Travel Respiratory Therapist | Charleston, SC · Travel Cardiopulmonary: Respiratory Therapy Charlest ...
-
Travel Respiratory Therapist
3 days ago
Triage Charleston, United StatesTriage is seeking an experienced Respiratory Therapist for an exciting Travel Allied job in Charleston, SC. Shift: Inquire Start Date: 06/17/2024 Duration: 13 weeks Pay: $ / Week Travel Respiratory Therapist | Charleston, SC · Travel Cardiopulmonary: Respiratory Therapy Charlest ...
-
Travel Respiratory Therapist
3 days ago
Triage Charleston, United StatesTriage is seeking an experienced Respiratory Therapist for an exciting Travel Allied job in Charleston, SC. Shift: Inquire Start Date: 06/17/2024 Duration: 13 weeks Pay: $ / Week Travel Respiratory Therapist | Charleston, SC · Travel Cardiopulmonary: Respiratory Therapy Charlest ...
-
One Call Specialist
6 days ago
TC Energy LLC Charleston, United StatesOur US Pipeline Safety Compliance team is seeking a One Call Specialist for a team that successfully manages one call tickets. The One Call Specialist is a strategic member of our pipeline safety team. The Specialist will support our commitment to sa Specialist, Operations, Damag ...
-
Health and Human Resources Specialist
5 days ago
State of West Virginia Charleston, United StatesLocated in the Division of STD, HIV, Hepatitis, and TB Elimination of the Office of Epidemiology and Prevention Services, the STD Prevention Specialist will work at the full performance level coordinating public health efforts to: Prevent and control sexually transmitted diseases ...
-
Stonerise Home Health South Charleston Charleston, United StatesWhy join our Stonerise Home Health team? · We provide high-quality care to help patients maintain their independence and dignity in the comfort of their own homes. Our team includes nurses, physical therapists, occupational therapists, speech language pathologists, social workers ...
-
CAMC Health System Charleston, United StatesJob Summary · Provide diagnostic and surgical services to the patients of CAMC and its affiliates per the terms of the contract. · Responsibilities · • To provide care to CAMC patients in the field of Oral Maxillofacial Surgery in compliance with the highest standards of medical ...
-
CAMC Health System Charleston, United StatesJob Summary · Provide diagnostic and surgical services to the patients of CAMC and its affiliates per the terms of the contract. · Responsibilities · • To provide care to CAMC patients in the field of Oral Maxillofacial Surgery in compliance with the highest standards of medical ...
-
Clinical Informatics Specialist
5 days ago
Applab Systems Inc virginia, United States· Hi, · Hope you are doing good... · I am Baiju represented to Applab Systems and I have an excellent job opportunity for you. Please find the below job description and if you are comfortable, please reply or contact me for further discussion. · Job Title: Clinical Informatics S ...
-
CAMC Health System Charleston, United StatesJob Summary · Provide evaluation and treatment services to the patients of the Charleston Area Medical Center, Inc. and its affiliates per the terms of the employment contract. Serve as Medical Director Echocardiography. · Responsibilities · Physician will provide care to CAMC pa ...
Senior Quality and Compliance Specialist - Charleston, United States - MMS Holdings Inc.
2 weeks ago
Description
MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma's international awards programs for the last three consecutive years. For more information, visit or follow MMS on .
Job Specific Skills:
