Quality Assurance Specialist III

Job Summary

Revance is on a mission to disrupt the biotechnology industry with forward-thinking technology that powers the patient care experience. With a strong legacy as a biotechnology R&D house. Revance is focused on delivering innovative aesthetic and therapeutic products that provide exceptional, meaningful outcomes to consumers. Come be a part of our journey in setting a new standard.

This position is responsible for monitoring, maintaining and supporting Quality Systems, Compliance and Supplier Quality programs across clinical and commercial operations. Assists in quality systems and compliance activities including but not limited to: deviations, CAPAs, change control, supplier quality, audit management and preparation of metrics to support management review. Works on assignments that are complex in nature where judgement is required in resolving problems and making recommendations. Normally receives no instruction on routine work and provides recommendations on new assignments.

Essential Functions:

• Reviews and approves quality system records (e.g. minor Deviations, CAPA, Change Control, etc.) as well as Instrument/Equipment Master Records, Work Orders, and Out of Tolerance (OOT) records.
• Reviews, assesses, and coordinates supplier questionnaires in accordance with vendor management and monitoring program. Manages updates to the Approved Supplier List.
• Reviews and approves validation life cycle documentation including executed protocols.
• Proactively leads the collection and tracking of quality system metrics and databases for department and management review to assure compliance and continuous improvement.
• Maintains, verifies, and ensures correct and complete database entries. Conducts audits on a periodic basis to ensure accuracy and compliance with department processes and procedures.
• Ensures data integrity and security of databases and documents containing data relevant to product quality and/or Quality Systems processes.
• Manages the archival of hardcopy and electronic versions of quality system records and supplier files.
• Participates in developing and improving Standard Operating Procedures to ensure quality objectives are met.
• Performs a wide variety of activities to ensure compliance with applicable quality objectives, current Good Manufacturing Practices (GMPs) and applicable regulatory requirements.
• Provides support with internal and regulatory audits and inspections as required.
• Works directly with operating entities to ensure that compliance commitments are met on a continuing basis as specified to enforce requirements.
• Applies company policies and procedures to resolve a variety of moderately complex issues. Exercises good judgement in selecting methods and techniques within defined procedures and practices to determine appropriate action.
• Keeps abreast of requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Notifies manager of compliance questions and issues.

Preferred Experience:

• At least 6 years of relevant experience in the pharmaceutical/biotech industry or equivalent combination.
• Works under limited supervision; demonstrating a level of independence and providing recommendations for continuous improvements.

Knowledge and Skills:

• Demonstrates proficiency in application of QA systems principles and standards, current industry practices, and applicable regulations including 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents.
• Demonstrates proficiency with managing databases and has advanced knowledge of the Microsoft suite (i.e. Word, Excel, Visio, Power Point, etc.) and Adobe.
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Effective time management, organizational and planning skills.
• Possesses initiative and is proactive.
• Builds productive internal and external working relationships.
• Must work effectively within teams with rapidly changing priorities.
• Demonstrates good coping skills and analytical problem solving skills.

Required Education:

Typically a BA/BS or equivalent combination of related education and experience

WORK ENVIRONMENT & PHYSICAL DEMANDS

This section of the job description is required by the American with Disability Act, (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 10 pounds at times

We are an equal opportunity employer. We are a company where diverse backgrounds, experiences and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.