Sr. Quality & Regulatory Specialist
Job description
For over 40 years, Charles River Cell Solutions has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies.
We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making Cell Solutions a rewarding and valuable place to work. We believe in making a difference, and at Cell Solutions, you will make a difference every day.
IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
Job Summary
This position will provide support to ensure the organization maintains compliance with the organization’s Quality Systems, current Good Manufacturing Practices (cGMPs), current Good Tissue Practice (cGTPs), and in adherence with all applicable Federal, State, local, international, and industry regulations and standards. This position will also oversee the management of regulatory documentation related to the organization’s Institutional Review Board (IRB) activities, will be responsible for maintaining regulatory documentation associated with clinical trials and will assist with the new and ongoing qualification of suppliers performing collections under separate IRB jurisdiction.
- Performs job functions in compliance with all quality systems, FDA/EMA and other applicable international requirements related to GMPs and GTPs, State regulations and AABB Accreditation standards. Maintains training competency on applicable Quality Assurance, Quality Systems, and Regulatory policies and procedures.
- Maintains all forms, logs and other applicable records and spreadsheets related to the job functions.
- Maintains confidentiality of donor information and materials.
- Assists in the preparation of records prior to and during external assessments.
- Manages documentation associated with all IRB activities related to sponsor and study site submissions and approvals for studies where our organization is the sponsor.
- Establishes and maintains research files and documentation pertaining to regulatory requirements for all clinical trials for which our company acts as a study site or leukapheresis center.
- Meets with monitors from pharmaceutical companies/study sponsors/CROs, along with other management staff.
- Works with outside clinical trial coordinators, CROs, research staff, and investigators to assure that all regulatory documents for their research studies are current.
- Works with departmental staff to ensure internal operational procedures and protocols are developed to comply with study protocol requirements.
- Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
- Assists QA management staff with initial and ongoing supplier qualifications of contracted collection entities operating under separate IRB study protocols and consents.
- Verifies that supplier files contain documentation verifying current IRB approvals for collections being performed under external IRB study protocols and consents.
- Assists with the management of Quality System Reports (QSRs), including deviations, corrective and preventive actions (CAPA), exceptions, customer complaints, and post-donation information. Notify management and departments for any issues impacting SQuIPP of products.
- Assist with developing, maintaining and training on QA, Quality Systems and Regulatory policies and procedures.
- Maintains current licensure, registration and certification documentation.
- Maintain working knowledge of donor suitability criteria and infectious disease testing.
- Maintains, reviews and updates donor deferral documentation on all applicable records and in the Blood Establishment Computer System.
- Works closely with the Medical Director and QA management staff to create and draft donor deferral letters and consignee/customer notification letters.
Job Qualifications
- B.S., B.A. or Associate Degree preferred, but not required if work history is equivalent.
- Minimum four (4) years of related experience or equivalent combination of education and experience.
- Nationally recognized Research Professional Certification (e.g., SOCRA, CRS or Association for Clinical Research Professional) preferred, but not required
- Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.
- Ability to quickly learn new software programs as needed.
The pay range for this position is $67,000-82,800. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
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