Sr. Quality Assurance Specialist (QSC)
Posted on: June 6, 2021
This position will primarily support the Vendor Management
Program across clinical and commercial operations. May assist in
other areas of quality systems and compliance, including but not
limited to, deviations, CAPAs, change control, and inspection
readiness/management. Works on assignments that are complex in
nature where judgment is required in resolving problems and making
recommendations. Normally receives no instruction on routine work
and provides recommendations on new assignments.
- Maintains the internal and external audit schedules.
- Reviews, assesses, and coordinates audit questionnaires in
accordance with vendor management and monitoring program.
- Authors vendor assessments for questionnaires reviewed.
- Performs internal audits and external audits as needed.
- Authors audit reports for internal and external audits
- Coordinates external audits with consultant auditors.
- Tracks vendor change notifications and communicates them to
impacted functional areas for impact assessment.
- Routes vendor and consultant contracts (e.g. NDA, SOW) in
Contracts Management System and tracks timely approval of
- Generates metrics related to internal and external audits.
- Supports the review and approval of quality system records
(e.g. Deviations, CAPA, Change Control, etc.).
- Supports inspection readiness/management.
- 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.
- 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 judgment 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.
BA/BS or equivalent combination of related education and
- At least 7 years of relevant experience in the
pharmaceutical/biotech industry or equivalent combination.
- Experience in internal and external audits, including
- Works under limited supervision; demonstrating a level of
independence and providing recommendations for continuous
Knowledge, Skills and Abilities
- 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
- Comprehensive knowledge of audit standard, practices and
- Demonstrates ability to perform detail-oriented work with a
high degree of accuracy.
- Demonstrates excellent verbal, written, and interpersonal
- Effective time management, organizational and planning
- Possesses initiative and is proactive.
- Builds productive internal and external working
- Must work effectively within teams with rapidly changing
- Demonstrates good coping skills and analytical problem-solving
- Experience with databases and has advanced knowledge of the
Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.).
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.
Keywords: Revance, Newark , Sr. Quality Assurance Specialist (QSC), Other , Newark, California
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