Senior Compliance Specialist
The Senior Compliance Specialist is responsible for ensuring Berg Quality Systems are of the highest quality by maintaining and improving compliance to procedures, policies, and guidelines.
- Assist in the management of the electronic Quality Management System (eQMS) (MasterControl).
- Author and review SOPs, as well as, review non-departmental SOPs.
- Provide day-to-day management of document control processes and workflows within the eQMS.
- Oversee Laboratory notebook management and procedures.
- Oversee Quality documentation, records, and filing.
- Assist and facilitate inspection readiness program, and procedures.
- Assist in the review and approval of GMP documentation.
- Manage change control, CAPA, deviation, and investigation programs
- Assist in the management of the internal and external audit program, which includes, focus on GxP, GLP, and GCP compliance, regulatory agency inspection readiness, and for-cause inspections.
- Provide support to the Clinical team and Laboratory team to ensure compliance with GCP, GLP, and applicable regulatory requirements.
- Work with clinical operations and regulatory affairs to review regulatory submission documents.
- Facilitate vendor management for all GxP functional area departments.
- Assist in the development and approval of Quality Agreements with vendors.
- Oversee and/or conduct QA review of clinical protocols, Investigator Brochures, and reports.
- Maintain relationships with vendors, contractors, and consultants to ensure the effective execution of assigned tasks.
- Responsible for the facilitation and maintenance of training records.
- Responsible for records management and facilitation of off-site records storage.
- Assist in the review and completion of Trial Master Files (TMFs).
- Other duties, as assigned
- Requires a Bachelor’s (Master’s degree preferred) in a related scientific discipline with 3-5 years’ experience in a GxP regulated environment
- Must be certified in compliance; preferably in Healthcare Research Compliance (https://www.hcca-info.org/certification/become-certified/chrc)
- Must have previous experience with an eQMS System
- Broad knowledge of clinical processes and procedures, electronic documentation systems, and Good Clinical Practices 21CFR Parts 50, 56, 312 and Good Manufacturing Practices
- Must demonstrate attention to detail and excellent record keeping skills
- Must be proficient in MS Office Suite (e.g. Word, Excel, PPT) required for review and preparation of documents and reports for inspections
- Proven ability to find creative, practical solutions to complex problems
- Excellent communication and interpersonal skills
- Superior and proven organizational skills
- Ability to multi-task and work in a team-oriented fast-paced environment