- Provides oversight for all GCP and GLP vendors supporting Supernus Clinical Activities in accordance with the Supernus Supplier Quality Program.
- Performs external GCP and GLP audits, investigation site audits and internal bioanalytical audits.
- Reviews and approves clinical and bioanalytical protocols and reports.
- Reviews and approves internal and external deviations, investigations, OOS, CAPA and change controls relevant to Supernus clinical activities.
- Reviews bioanalytical method validation protocols and technical reports.
- Revises and maintains the Quality Compliance systems in accordance with U.S. regulations and internal standards to ensure the quality of clinical trial material being produced.
- Initiates new or revises existing SOPs for Quality Compliance to support Supernus clinical activities.
- Stays current with changes, amendments to the CFR and/or FDA guidance documents to ensure that Supernus' compliance policies and procedures are up to date.
- Assists in all regulatory agencies' inspections regarding Supernus products.
- Participates in project meetings, company task force, and compliance initiative teams, to provide the QA perspective and technical support as needed.
- Other duties as assigned.
- N/A
- S. in a life sciences discipline.
- 5+ years of experience in GCP environment.
- Comprehensive understanding of GCPs, and cGLPs and their application to a wide variety of problems and situations.
- Proficiency in Microsoft Office Suite.
- Strong communication and technical writing skills.
- Ability to work independently, as well as ability to function as a team player, ability to accept personal accountability for successful job performance, and ability to initiate and offer suggestions aimed at improving service to our customers.
- Ability to be flexible and to work efficiently and accurately to meet set goals and timelines.
- Travel is required (approximately 35%)
- Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
- Ability of having an innovative and dynamic approach to work.
- A self-starter able to work independently but comfortable working in a team environment.
- Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
- Capable of performing other duties as assigned by Management.
- Authorized to legally work in the United States without visa sponsorship.
- Travel is required (approximately 25%).
- Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, and crouching; the ability to push, pull, drag and/or lift up to 20 pounds; normal manual dexterity and hand/eye coordination
- The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading
- The worker is not substantially exposed to adverse environmental conditions
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Senior Quality Compliance Associate- CLINICAL - Rockville, United States - Supernus
Description
Job Summary:
To perform various quality assurance activities including but not limited to maintaining the compliance systems in accordance with U.S. and internal regulations and standards.
Essential Duties & Responsibilities:
Essential Duties & Responsibilities:
Supervisory Responsibilities:
Knowledge & Other Qualifications:
Other Characteristics:
Physical Requirements/Work Environment/Travel Requirements:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.
