Quality Assurance Engineer **Bonus Available**

Company: Avantor
Location: Niagara Falls
Posted on: September 19, 2022

Job Description:

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 reports.
• 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 Quality System.
• 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 findings.
• Assists in creation and maintenance of quality documentation.
• Evaluate impact of process improvement efforts and manufacturing deviations on process validation.
• Demonstrates good communication and project management skills.
• Collaborate with team members to support company goals.QUALIFICATIONS:
  • 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, and experience
  • Minimum 3 - 5 years' experience in a quality engineering role, in a manufacturing facility preferred
  • Working knowledge of problem-solving tools and Root Cause Analysis required.
  • Proven Understanding of ISO 9001:2015.
  • Process Validation or cleaning validation experience desired.
  • Work experience in Chemical, Pharmaceutical, Medical Device, or Food Industry strongly preferred.ADDITIONAL KNOWLEDGE SKILLS AND ABILITIES:
    • ASQ Certified Quality Engineer, or ASQ Certified Quality Auditor or currently pursuing certification preferred.
    • Can work independently and optimally in a team environment.
    • 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 location.

Keywords: Avantor, Niagara Falls , Quality Assurance Engineer **Bonus Available**, Engineering , Niagara Falls, New York