Veterans Preferred - Validation Compliance Manager
Company: US11345-AIRGAS Airgas USA, LLC
Location: Houston
Posted on: April 18, 2024
Job Description:
Military Veterans are Encouraged to Apply. -R10040446 Validation
Compliance Manager (Open)
Location:
Houston, TX - WLY - Cust. installations
How will you CONTRIBUTE and GROW?
We are HIRING!!
Airgas is Hiring for a REMOTE Validation Compliance Manager!
At Airgas, we RESPECT, HONOR and VALUE diversity. We are invested
in cultivating a dynamic and inclusive culture.
We are looking for you!
- Location: Fully remote
- Reports to: Senior Director of Quality & Food Safety
- Travel: 30-50%
- Strong passion for fostering an environment of Diversity,
Inclusion and Respect.
- Experience with developing, contributing, and supporting
Airgas' commitment to a World Class Service, exceeding customer
expectations and building brand loyalty.
Excellent Benefits: Airgas offers a full benefits package that
includes: Medical, Dental, Vision, Life, AD&D, Short Term and
Long Term Disability Insurance, Vacation, Sick, Paid Holidays, 14
weeks paid child birth benefit, 401(k) Retirement Plan with company
match, Tuition Assistance and much more! Benefits Start after 30
days of employment.
Recruiter: Laura Brewer / laura.brewer@airgas.com /
832-954-4791
How will you CONTRIBUTE and GROW?
Job Description Summary: The Validation and Compliance Manager
position supports Airgas Merchant Gases (AMG) by leading the
validation and qualification of medical product manufacturing and
fill systems, analytical equipment and associated software as
required by FDA drug manufacturer regulations. The manager assures
systems are compliant with Food Safety System Certification (FSSC)
22000; FDA & applicable international regulations, & company
standards for system integration, maintenance, and continual
improvement.
- Manages Department Validation project initiatives; third party
contracted validation services and consultants as applicable.
Assign validation tasks and ensure timely completion per
established schedules.
- Develop validation test protocols to maintain medical
compliance and for special projects.
- Review and approve validation reports from internal & third
party execution regarding; qualification policies, procedures,
protocols and consultant qualifications.
- Manage the performance of process and analytical validations as
assigned by Senior Director Food Safety & Quality
Compliance
- Develop, implement and provide guidance on validation
strategies, procedures and policies as assigned.
- Research, interpret and apply U.S. and international
regulations and standards in relation to the validation of medical
product production facilities and analytical instruments in the
testing of food, drugs, and medical devices. Develop action plans
when required.
- Assist with Regulatory audits at medical and food facilities
when required.
- Develop validation and qualification training programs when
required.
- Assist the Department with compliance audit report review and
investigations concerning validation activities.
- Lead in multi-functional teams to identify analytical best
practices, and assist in developing standard validation,
qualification and calibration procedures.
- Perform validation assessments of new and existing locations to
determine the level of validation required.
- Monitors the facility Management of Change requests to assure
that process changes do not adversely affect previous
validation.
- Prepare internal communication reports and presentations for
validation and quality activities.
- Represents Airgas on industry trade organization task forces
directly relating to validation, such as the CGA, as assigned by
the manager.
- Assure Airgas Merchant Gases (AMG) Bulk and Onsite Group
programs are compliant with current FDA food and drug regulations
and all other state, federal, and international statutory and
regulatory requirements.
- Support AMG operations, distribution, and sales teams to
achieve growth objectives and strategies.
- Supports customer service and product complaints and Root Cause
Analysis activities
- Provide corporate and field advisory support for FDA government
inspections, customer and certification audits.
- Assists in developing AMG policies and procedures to ensure
compliance with regulatory requirements.
- Assure manufacturing and product delivery processes used for
the manufacture, storage and delivery of drug products are properly
validated in accordance with FDA 21 CFR 210 & 211 and CGA
requirements.
- Assure that manufacturing and product delivery processes used
for the manufacture, storage and delivery of food products are
properly assessed per FSSC 22000 requirements and FDA 21 CFR 117
Food Safety Standards.
- Monitor programs and identify compliance gaps. Initiates
actions to close gaps prior to regulatory action.
- Promotes field Quality and Compliance awareness through the
sharing performance metrics and relevant audit data.
- Lead quality and compliance training programs for new
facilities to ensure that AMG personnel maintain good working
knowledge of regulatory requirements.
- Utilize cost benefit analysis and risk based methodologies when
drafting quality and compliance program improvements.
- Solicit input from stakeholders to gauge impact of change prior
to implementing program revisions.
- Incorporates established root cause analysis methodologies when
conducting investigations and identifying effective
resolution.
- Promote continual improvement within the group and partners
with internal organizations when implementing business
improvements.
- Monitors and maintains product quality specifications and
advises sales teams of site product capability.
- Assist with qualifying sites for ABO and other products used
for military applications.
- Ensure that quality and compliance staff is adequately trained
to perform all required duties and to remain current on new
regulations and quality trends.
- Provide product quality, analytical and compliance support for
product and process related issues
- Facilitate and participate in Site HACCP HARPC & Risk
Mitigation Planning
- Is a member of and participates in Quality-related activities
of CGA and ISBT
- Supports Customer Advocacy program by provides
customer-requested letters of guarantee, certificates of
conformance and other product quality assurance correspondence as
necessary.
- Serves as TCL analytical expert in support of production group
expansion and improvement initiatives.
- Communicates directly with customers in support of product
related complaints and supports investigations where analytical
expertise is required.
________________________
Are you a MATCH?
Are you a MATCH?
Required Qualifications
- Qualified candidates must possess a Bachelor's degree in
Engineering or Natural Science or combination of education and
equivalent work experience in Quality Management
- Master's Degree a plus.
- Five (5) to eight (8) years of quality management experience
and with supervising a staff required.
- Previous experience in the industrial, Electronic, and/or
specialty gas business preferred.
- Strong understanding of analytical validation principles in
relation USFDA, Health Canada, European, and other international
regulations.
- Strong understanding of HACCP/HARPC Risk management principles
and programs
- Understanding of USFDA, Health Canada, European, and other
international regulations and standards.
- Five (5) years experience in analytical instruments relating to
operation and calibration of instruments for testing drugs or
medical devices.
- Five (5) years experience in a medical, biologic, or food
regulated environment.
- Eight (8) years experience in managing personnel and/or project
teams.
- Working knowledge of Microsoft Office applications (Word,
Excel, PowerPoint, and Outlook)
- Working knowledge of Google applications (Chrome, Docs, Sheets,
Slides, Drive and Gmail)
Preferred Qualifications
- Certified Lead Auditor for ISO 9001, 13485, 17025, or FSSC
22000.
- CQA, QE, CQT, CMQ/OE, HACCP RMR, CSSBB beneficial.
About Airgas
Airgas, an Air Liquide company, is a leading U.S. supplier of
industrial, medical and specialty gasses, as well as hardgoods and
related products; one of the largest U.S. suppliers of safety
products. Through the passion and diversity of its 18,000
associates, Airgas fosters a culture of safety, customer success,
sustainability and innovation. Airgas associates are empowered to
share ideas, take initiative and make decisions.
Airgas is a subsidiary of Air Liquide, a world leader in gasses,
technologies and services for Industry and Health. Air Liquide is
present in 78 countries with approximately 64,500 associates
globally.
Join us for a stimulating experience: you'll find a world of
learning and development opportunities where inventiveness is at
the heart of what we do, in an open, collaborative and respectful
environment.
Recruiter: Laura Brewer / laura.brewer@airgas.com /
832-954-4791
_________________________
Your differences enhance our performance
At Airgas, we are committed to building a diverse and inclusive
workplace that embraces the diversity of our employees, our
customers, patients, community stakeholders and cultures across the
world.
We welcome and consider applications from all qualified applicants,
regardless of their race, gender, sexual orientation, religion,
disability or any other protected characteristic. We strongly
believe a diverse organization opens up opportunities for people to
express their talent, both individually and collectively and it
helps foster our ability to innovate by living our fundamentals,
acting for our success and creating an engaging environment in a
changing world.
_________________________
Equal Employment Opportunity Information
We are an equal opportunity employer. We evaluate qualified
applicants without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, disability, veteran
status, or any other protected characteristic.
Please click here to view the EEO Know Your Rights poster and here
to view the Pay Transparency Nondiscrimination poster. Airgas, an
Air Liquide Company invites any applicant and/or employee to review
the Company's written Affirmative Action Plan or Policy Statement.
This plan or policy statement is available for inspection upon
request.
Airgas, an Air Liquide Company and its group of companies does not
discriminate against qualified applicants with disabilities and is
committed to providing reasonable accommodations to the known
disabilities of such individuals so as to ensure equal access to
benefits and privileges of employment. If you are an individual
with a disability and would like to request a reasonable
accommodation as part of the employment selection process, please
contact us by email at us-accommodationrequest@airgas.com .
_________________________
California Privacy Notice
Keywords: US11345-AIRGAS Airgas USA, LLC, Houston , Veterans Preferred - Validation Compliance Manager, Executive , Houston, Texas
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