About this role
The Opportunity:
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Under broad supervision, conducts internal quality controls to ensure established quality procedures and norms are followed. Conducts non-routine quality analysis and tests/inspections of a quality control program, resolving most questions and problems and recommends necessary quality procedure changes. Monitors and records inconsistencies with quality procedures and norms. Records and analyzes customer claims and prepares reports on rejected or defective products. May assist in the development of new methods and procedures.
Are you passionate about quality, compliance, and continuous improvement? Do you enjoy coordinating projects, collaborating across teams, and ensuring products meet the highest standards? We are looking for a Quality Assurance Specialist to join our team and play a key role in supporting quality processes, documentation, and product release activities.
About the Role
As a Quality Assurance Specialist, you will be responsible for coordinating and independently managing projects while providing guidance and support within the quality function. You will work closely with cross-functional teams to maintain compliance, support quality systems, and contribute to continuous improvement initiatives.
Key Responsibilities
Quality & Compliance
- Maintain and support quality systems and quality documentation.
- Perform electronic data entry and manage the distribution and updating of QA forms.
- Generate, review, revise, and maintain controlled documentation.
- Edit and update procedures and policies as required.
- Communicate QA standards and expectations across departments.
- Support material release activities requiring a high level of attention to detail.
- Assist with released material movement and product disposition documentation.
- Generate variance reports and other product-related reports.
Project Coordination & Process Improvement
- Coordinate and independently manage assigned projects.
- Lead cross-functional meetings related to project activities when required.
- Analyze existing procedures and policies and contribute to continuous improvement initiatives.
- Provide information, guidance, and support to team members within the functional area.
Quality Systems & Audits
- Participate in ISO 9001 audits and contribute to ISO 9001 program documentation and implementation.
- Ensure compliance with applicable procedures, standards, and regulations.
- Act independently as the Qualified Person for product disposition, release, or rejection when applicable.
- Ensure each batch has been manufactured and tested according to established release procedures.
Team Support
- Assist with training and cross-training of department personnel.
- Serve as a temporary backup for team members when required.
- Support the development and knowledge sharing of colleagues within the department.
What We're Looking For
Education & Experience
- Bachelor's degree from a four-year college or technical school, or
- Minimum two years of Quality Assurance experience within an ISO-registered company, or
- An equivalent combination of education and experience.
- Strong computer skills, including proficiency with: Microsoft Word Microsoft Excel Microsoft Outlook Microsoft PowerPoint
- Experience with Agile methodologies is considered a plus.
### Skills & Competencies
Communication Skills
- Ability to read, analyze, and interpret business documents, technical procedures, and regulatory requirements.
- Strong report writing, business correspondence, and procedural documentation skills.
Analytical Skills
- Basic understanding of statistics and business performance metrics.
- Ability to analyze business systems and processes and translate findings into actionable recommendations.
- Strong problem-solving and decision-making skills.
Working Style
- Comfortable managing multiple priorities in a fast-paced environment.
- Able to work independently with limited supervision.
- Strong attention to detail and commitment to quality.
- Team-oriented with excellent communication and collaboration skills.
- Positive attitude, professionalism, and dependable attendance.
Physical Requirements
This position requires:
- Regular sitting, standing, walking, reaching, talking, and hearing.
- Occasional lifting or moving of items up to 25 lbs (approximately 11 kg).
- Ability to meet visual requirements including close vision, distance vision, depth perception, color vision, and focus adjustment.
For safety reasons, contact lenses are not permitted in production, laboratory, engineering shop, or equipment work areas. Prescription safety glasses will be provided where applicable.
Work Environment
- Moderate noise level.
- Ability to work in non-climate-controlled environments when required.
- Collaborative and quality-focused workplace culture.
Ready to take the next step in your career? We'd love to hear from you!
#LI-Onsite
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 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's 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 mom's 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 [email protected] 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.
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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.