Quality Assurance Engineer **Bonus Available**
Location: Niagara Falls
Posted on: September 19, 2022
Job SummaryThe Quality Assurance Engineer (Biopharma/Chemicals)
is responsible for quality assurance activities, with oversight of
investigations, root cause analysis, validations, quality
procedures, and continuous improvements.**Bonus and Additional
Incentive/s availableLocation: Position will be onsite in Sanborn,
NYMAJOR JOB DUTIES & RESPONSIBILITIES:
- Use Quality Engineering principles, tools, and techniques to
develop and optimize systems and processes so that they are aligned
with company strategy and regulatory requirements.
- Perform root cause analysis, identify and implement corrective
actions for non-conformances and customer complaints
- Review and approve quality assurance documents - risk
assessments, validation protocols/reports, change managements
records, CAPAs, Non-conforming material reports, trend
- Collect, review, and interpret data for trend reporting,
metrics, quality system review and complaints.
- Responsible for managing Quality System programs, including
calibration and environmental monitoring.
- Responsible for continual improvement activities to enhance the
- Develops and performs training to build quality awareness
throughout the company.
- Collaborate with Manufacturing, Research and Development and
Engineering to ensure transfer of newly developed products in
accordance with approved data and analysis.
- Conducts audits (internal and supplier) to monitor compliance
with ISO 9001:2015, including creating audit finding reports,
working with multi-functional teams to determine and implement
proper corrective and preventive action, and closing out audit
- Assists in creation and maintenance of quality
- Evaluate impact of process improvement efforts and
manufacturing deviations on process validation.
- Demonstrates good communication and project management
- Collaborate with team members to support company
- Bachelor's degree required, preferably in a natural/life
science, engineering field with proficiency in one of the following
areas (preferred): Chemistry, Biology, Microbiology, or cell
culture; Or an equivalent combination of education, certification,
- Minimum 3 - 5 years' experience in a quality engineering role,
in a manufacturing facility preferred
- Working knowledge of problem-solving tools and Root Cause
- Proven Understanding of ISO 9001:2015.
- Process Validation or cleaning validation experience
- Work experience in Chemical, Pharmaceutical, Medical Device, or
Food Industry strongly preferred.ADDITIONAL KNOWLEDGE SKILLS AND
- ASQ Certified Quality Engineer, or ASQ Certified Quality
Auditor or currently pursuing certification preferred.
- Can work independently and optimally in a team
- Can identify problems and communicate solutions in a
constructive and positive manner.
- Attention to detail; excellent organizational and record
keeping skills. -
- Excellent Technical Writing/ Report writing skills.
- Working knowledge and experience with LEAN, Six Sigma
methodologies.DISCLAIMER:The above statements are intended to
describe the general nature and level of work being performed by
employees assigned to this classification. They are not intended to
be construed as an exhaustive list of all responsibilities, duties
and skills required of employees assigned to this position.Avantor
is proud to be an equal opportunity employer.EEO Statement:We are
an Equal Employment/Affirmative Action employer. We do not
discriminate in hiring on the basis of sex, gender identity, sexual
orientation, race, color, religious creed, national origin,
physical or mental disability, protected Veteran status, or any
other characteristic protected by federal, state/province, or local
law. If you need a reasonable accommodation for any part of the
employment process, please contact us by email at and let us know
the nature of your request and your contact information. Requests
for accommodation will be considered on a case-by-case basis.
Please note that only inquiries concerning a request for reasonable
accommodation will be responded to from this email address.For more
information about equal employment opportunity protections, please
view the Equal Employment Opportunity is THE LAW Poster, EEO is the
Law Poster Supplement, and Pay Transparency Non-Discrimination
Provision using the links below.3rd Party Non-Solicitation
Policy:By submitting candidates without having been formally
assigned on and contracted for a specific job requisition by
Avantor, or by failing to comply with the Avantor recruitment
process, you forfeit any fee on the submitted candidates,
regardless of your usual terms and conditions. Avantor works with a
preferred supplier list and will take the initiative to engage with
recruitment agencies based on its needs and will not be accepting
any form of solicitation.Colorado and New York Equal Pay
Transparency:Avantor is committed to equitable compensation
practices. The compensation range for this role is:$70,000.00 -
$119,000.00Final compensation for this role will be determined by
various factors such as minimum and preferred qualifications,
knowledge, skills, abilities, education, experience and
Keywords: Avantor, Niagara Falls , Quality Assurance Engineer **Bonus Available**, Engineering , Niagara Falls, New York
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