Senior Quality Assurance Compliance Specialist
Company: AmplifyBio
Location: New Albany
Posted on: November 1, 2024
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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 ADOC South San Francisco, CA. AmplifyBios discovery
optimization and characterization unit (ADOC) establishes critical
product characterization benchmarks, optimizes efficacy, and
identifies new targets and strategies for clients preparing to
scale up the production of therapeutic candidates. The site also
houses GMP manufacturing suites, and quality labs available to
clients. Based on broad experience in cell and gene therapy
manufacturing, this group seeks to address the widening gap between
R&D and manufacturing CMC.AmplifyBio is seeking to hire a Sr.
QA Compliance Specialist to join our growing team!!!The Sr. QA
Compliance Specialist is responsible for the management and
execution of the Suppler Quality Management (SQM) and Audit
Programs for the New Albany GMP facility. This role will ensure
supplier qualifications, external and internal audits are performed
in a timely manner to meet quality and business objectives. The
ideal candidate is a hands-on leader with experience in GMP
regulated environments.What Youll Do Here:Enhance and manage
existing procedures for: the selection and management of GMP
suppliers and the execution of the audit program (internal,
external and client audits).Maintain GMP vendor files, Approved
Supplier List (ASL) and conduct periodic assessment to ensure all
vendor certification documents, licenses, and statements are
current.Participate in drafting quality technical agreements as
required.Co-manage the Material Review Board with QA Ops.Develop
and manage the supplier and internal audit schedule, generate audit
plans and conduct routine quality audits of GMP suppliers / service
providers and internal QMS.Maintain all audit reports, audit
responses, and pertinent corrective actions up to dateConduct
follow-ups for internal and supplier audits corrective actions to
ensure closure.Support QA Operations team to investigate product
quality complaints, quality events, incidents and CAPAs associated
with materials or supplier services.Develop and report on KPIs /
metrics for SQM, and Audit Program to identify areas for
improvement.Provides site training on for the supplier and audit
programs to ensure process alignment.We Would Love to Hear From You
If: A Bachelors degree or higher in a relevant scientific
discipline Bioinformatics, Biology, Biochemistry, Chemistry or
equivalent education and experienceA minimum 5+ years of experience
in Quality and GxP biotechnology or pharmaceutical environment.Must
have experience with SQM and/or CQA . However, SQM and/or CQA
certifications are a plus. Understanding through prior experience
of GMP regulation and guidelines related to the conduct of early
phase clinical programs such as, 21 CFR Part 210 and 211.Must have
prior supplier qualification and auditing experience.Ability to
work with minimal supervision.Strong interpersonal skills, ability
to work in a team environment, attention to details and excellent
problem resolutions skills.Ability to apply a risk-based approach
related to this role.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 on the basis of 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, 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 FLEIXIBLE PTO
program!Generous paid parental leaveWellness and Self-Care
Programs401(k) matchTuition ReimbursementEAP/work-life support
systemA fun work environment where everyones voice matters.We are
just getting started! More benefits on the way!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.PI8ac5931b1289-25660-35256328
Keywords: AmplifyBio, Elyria , Senior Quality Assurance Compliance Specialist, Other , New Albany, Ohio
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