The Quality Assurance Engineer is responsible for quality assurance activities with oversight of investigations, the Quality Management System SOP’s, validations and quality continuous improvements. This position reports into the QA Manager.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
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.
Provide support for customer, regulatory and internal audits.
Use root cause analysis and risk assessment tools and techniques to perform investigations and determine appropriate corrective action.
Lead, coordinate and maintain validations for all departments.
Lead, coordinate and maintain Calibration Program.
Lead, coordinate and maintain Environmental Monitoring Program.
Conduct audits (both internal and supplier) and monitor compliance with ISO and FDA Quality System Regulation standards.
Collect, review, and interpret data for trend report, metrics, quality system review and complaints.
Update approved supplier index as required.
Review and approve quality assurance procedures and reports.
Maintain SOP’s and Quality Management System as directed by QA Manager.
Performs other duties as assigned.
QUALIFICATIONS (Education/Training, Experience and Certifications)
Bachelor’s degree in a natural/life science discipline with knowledge and experience in one of the following areas; Chemistry, Biology, Microbiology or cell culture; or an equivalent combination of education, certification and experience
CQE/CQA certification preferred
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
Minimum 3-5 years relevant experience
Excellent written and oral communication skills are required
Able to interface effectively with all levels of employees
Must be proficient in MS Office (Word, Excel, Access)
Experience in deviation and complaint investigations, including root cause analysis tools and technical writing required
Must be detailed oriented, with strong organizational skills, ability to multi-task, prioritize work load and work independently to meet commitments with minimal supervision
Experience conducting and supporting audits is required.
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.
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.
Some travel may be required.
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.
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 TalentManagement@vwr.com 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.