Senior/Quality Assurance Auditor (GLP)
Company: AmplifyBio
Location: West Jefferson
Posted on: October 9, 2024
|
|
Job Description:
Are you passionate about significantly improving the future of
medicine? Do you believe that people are the most important asset
of any company? If so, join AmplifyBio!AmplifyBio is a leading
contract research organization with a comprehensive range of
services that span from being an outsourcing partner for discovery
stage R&D work, a preclinical CRO performing safety efficacy
and toxicology studies for small molecules and advanced therapies
alike, and, most recently, an expansion into manufacturing services
for cell, gene, and mRNA-based therapeutics.The AmplifyBio
ecosystem is comprised of three distinct business units: ADOC
(South San Francisco, CA) Amplify's Discovery, Optimization, and
Characterization laboratories: ASET (West Jefferson, OH) Amplify's
Safety, Efficacy, and Toxicology Site; and the most recently opened
AMEC (New Albany, OH) Amplify's Manufacturing Enablement
Center.About ASET West Jefferson, OH: AmplifyBios safety, efficacy,
and toxicology unit (ASET) was launched as a preclinical CRO that
spun out of Battelle in 2021 to address the changing needs of
commercial organizations developing modern therapeutics. AmplifyBio
brings decades of experience to accommodate a wide variety of GLP
and non-GLP studies in all in vivo models and dose routes. Among
the investments that AmplifyBio has made to empower preclinical
assessments of advanced therapies is building a new
state-of-the-art analytical laboratory to include molecular and
immunological assays that assess critical safety and efficacy
indicators for cell and gene therapies during preclinical
studiesAmplifyBiois seeking to hire aSr./Quality Assurance
Auditor(GLP) to join our growing team!!!The Sr./QA Auditor (GLP)
Conducts audits and performs inspections to assure compliance to
federal regulations, AmplifyBio standards, client specifications,
internal policies, and any other applicable guidelines.What Youll
Do Here:Audits protocols, raw data, documents, records, reports,
and inspects work being performed to assure compliance to
regulatory requirements, standards, specifications, internal
policies, and any other applicable guidelines.Performs inspections
of AmplifyBio facilities and corresponding documentation to assure
compliance to requirements. Issues recommended actions and assesses
corrective actions based on observation(s).Reports audit findings
to project leadership and management.Advises operations regarding
issues observed during inspections to mitigate risk.May review
project planning documents (technical protocols, project plans,
test plans, etc.) for compliance with stated requirements.Utilizes
knowledge of specific instrumentation and equipment, laboratory
techniques, and current FDA industry guidance to advise on
compliant operations.Interprets and applies existing and new
regulatory requirements and industry standards to operations
methods and practices.Develops and executes Quality Assurance Audit
Plans per project.Demonstrates initiative and accountability, with
ownership of complex projects.Demonstrates ownership of assignments
with accountability and instills trust in project team.Act as
regulatory subject matter expert and amongst peers as a leader in
the organization.Identifies compliance gaps and actively drives
process/continuous improvement efforts to minimize risk to the
organization.Drives change management through use of effective
strategies and own skills in order to facilitate organizational
change initiatives.We Would Love to Hear from You If: Bachelors
Degree in a related field; 2-10 years of experience in a quality
assurance program and proven communication skills; or an equivalent
combination of education and/or experience in a related
field.Experience in a GLP environment or other regulated QA
Operations.Desired But Not Required:Experience with System
Validation and Method QualificationExperience with electronic
Quality Management Systems, Laboratory Information Management
Systems and 21 CFR Part 11 compliance.Experience interacting with
external audits and regulatory agencies.Proven leadership with
mentoring responsibilities.Proven risk management skills including
mitigation strategies.At AmplifyBio, we're committed to growing and
empowering an inclusive community within our company and industry.
This is why we hire and cultivate diverse teams of the best and
brightest from all backgrounds, experiences, and perspectives
across our organization.AmplifyBio is an equal opportunity
employer, and we value diversity at our company. We don't
discriminate based on race, color, citizenship status, national
origin, ancestry, gender (including gender expression and gender
identity), sexual orientation, age, weight, religion, creed,
physical or mental disability, marital status, veteran status,
political affiliation, or any other factor protected by federal,
state, or local law. Why You Will Love Working Here:We take the
health and happiness of our employees seriously and consistently
evaluate new ways to Amp up our benefits to provide an amazing
place to work. From a wellness program (did we mention we have an
onsite gym with state-of-the-art equipment and ping pong table?),
to financial planning and legal assistance, we make sure to take
care of our own.Health, Dental, and Vision insurance that starts on
your first day at AmplifyBio!Competitive Compensation PackageWe
take work-life balance seriously and we back it up with a FLEXIBLE
PTO policy!Generous paid parental leaveWellness and Self-Care
Programs401(k) matchTuition ReimbursementEAP/work-life support
systemA fun work environment where everyones voice matters!An
Opportunity to Change the World!!!When you join our team, you will
be a part of groundbreaking work while collaborating with our
clients, research scientists, study directors, lab technicians, and
specialists across a variety of disciplines. The future for
AmplifyBio is as great as the combination of our imaginations and
actions, and we hold ourselves accountable for our choices and
results. We have a bias for action, excellence, and, especially,
the health and safety of our
employees.PI983dd12ff9a8-25660-35750412
Keywords: AmplifyBio, Middletown , Senior/Quality Assurance Auditor (GLP), Accounting, Auditing , West Jefferson, Ohio
Click
here to apply!
|