Sr. Quality Engineer
Sr. Quality Engineer
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Job Description
The Opportunity:
Avantor is looking for a Sr. Quality Engineer to join our Quality Engineering team.
This is a fulltime onsite role in Paris KY.
What were looking for
- Education: Bachelor of Science degree in a scientific discipline; Concentration in Chemistry Biochemistry or Molecular Biology highly preferred
- Experience: 5 years of applicable work experience
- 3 years experience in quality auditing and/or project management
- Demonstrated experience and working knowledge of cGMPs and associated guidelines regulatory guidelines for the manufacture testing and release of quality related products
- Experience interacting with a quality management system
- Collaboration Tool: Advanced skills in MS Office products (e.g. Excel PowerPoint)
- Preferred Qualifications:
- Prior experience working within a chemical manufacturing environment
- ETQ Reliance
How you will thrive and create an impact
- Oversee writing revision implementation and training of standard operating procedures and work instructions.
- Ensures Quality System Requirements are met.
- Identify staff development needs in area such as training technical skills and safety.
- Communicate with customers with customers regarding quality related issues and complaints.
- Review test results for raw material inprocess and final product samples.
- Evaluate and implement new test methods as appropriate.
- Interpret and apply evolving regulatory and Quality standards.
- Interact as required with supply partners: raw materials filtration testing and gamma irradiation.
- Demonstrate strong presentation skills including the ability to prepare and deliver professional presentations to external business interests.
- Responsible for Batch review and approval C of A creation and CAPA process.
- Provide technical and quality operations support to other departments and contract manufacturers.
- Drive efficiency practices and policies that improve quality.
- Analyze trends to improve quality and allocate resources to drive continuous improvement.
- Prioritizing projects assigning tasks establishing completion dates and ensuring projects are completed on time.
- Review processing documentation/records and create Certificates of GI and HI as requested.
- Represent Avantor during Customer Audits. Coordinate timely responses to customer audit findings.
- Investigate and ensure appropriate root cause analysis is performed and effective CAPA implemented in response to Customer Complaints.
- Manage Avantors Document Control system within the EtQ system.
- Direct the quality organization activities at the facility with limited supervision
- Provide leadership and mentorship to greater team.
- Performs other duties as assigned.
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
- Strong written and verbal communication skills
- Strong analytical skills
- Ability to lead cross functional teams to execute on complex tasks in a growing and changing environment
- Knowledge and skills in root cause analysis and the CAPA process
- Demonstrated working with integrity and intensity
- Demonstrated entrepreneurial capability while working within a large company
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.
Ability to work in a regulated laboratory/production environment as required.
Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
A frequent volume of work and deadlines impose strain on routine basis.
Minimal physical effort is required. Work is mostly sedentary but does require walking standing bending reaching lifting or carrying objects that typically weigh less than 10 lbs.
#LIOnsite
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.
Why Avantor
Dare to go further in your career. Join our global team of 14000 associates whose passion for discovery and determination to overcome challenges relentlessly advances lifechanging science.
The work we do changes peoples lives for the better. It brings new patient treatments and therapies to market giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his moms voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
EEO Statement:
We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. 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 casebycase 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 Know Your Rights poster.
3rd Party NonSolicitation 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.
Required Experience:
Senior IC
Employment Type
Full-Time
