Quality Assurance Specialist III (Biotech)
Company: Revance
Location: Newark
Posted on: August 1, 2022
Job Description:
Job SummaryRevance 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.
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 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.
- Reviews, assesses, and coordinates supplier questionnaires in
accordance with vendor management and monitoring program. Manages
updates to the Approved Supplier List.
- 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.
- Provides support with internal and regulatory audits and
inspections.
- Works directly with operating entities to ensure that
compliance commitments are met on a continuing basis as specified
to enforce requirements.
- 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.
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, Power
Point, etc.) and Adobe Acrobat Pro.
- 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.
- Must work effectively within teams with rapidly changing
priorities.
- Demonstrates good coping skills and analytical problem-solving
skills.
Required Education: BA/BS required.
WORK ENVIRONMENT & PHYSICAL DEMANDSThis 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 20 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.
Keywords: Revance, Newark , Quality Assurance Specialist III (Biotech), Other , Newark, California
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