Avantor

The Opportunity:

As a Quality Assurance (QA) Batch Record Release Coordinator, you will be responsible for auditing paperwork for accuracy based on required documentation release, quarantine, or reject product, as needed. Additionally, you will monitor data using computer-based tracking programs on a routine basis.

You will have the opportunity to build strong relationships within our Quality Assurance Teams and interact with colleagues throughout the organization.

PRIMARY RESPONSIBILITIES

• Match and verify Batch Production Records (BPRs) and bench sheets for manufacturing related goods and perform audit of job packets and label reconciliation in accordance to ALCOA+
• Release material on Information Management System (IMS)
• Maintain BPRs audit log including tracking audit results statistics
• Filing and storage of quality records
• Support in the monthly stability / retention samples traceability and completed results in system
• Maintain quality status of inventory and support with Material Review Board (MRB) process of related goods
• Assist in Quality system maintenance such as the creation and maintenance of quality documentation
• Input, track local and tiered level quality objectives into relevant system for data analysis
• Collaborate with team members to support company and assigned goals
• Support in all internal, external and customer audits for documentation readiness
• Support and participate in any quality event / complaint / change control and other quality modules for compliance
• Perform verification work such as access control and audit trail of laboratory equipment
• Support in any validation related documentation to ensure accurate, completeness and compliance.
• Any other ad-hoc task / project assigned.

QUALIFICATIONS

• Diploma/high vocational certificate or university degree
• Quality Assurance experience in a manufacturing environment including significant auditing experience preferred
• Strong IT skills, including proficiency with Excel, Word, PowerPoint, and basic business tools Functional knowledge and experience in all areas of quality and/or compliance based on practical experience, including Food & Drug Administration (FDA) regulations and Current Good Manufacturing Practice (CGMP) requirements
• Solid understanding of chemical nomenclature and general manufacturing concepts and terminology
• Experience with SAP highly preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Ability to work collaboratively in a team and create an inclusive environment with people at all levels of the organization
• Ability to communicate complex ideas effectively, both verbally and in writing, in English and the local office language(s)
• Ability to effectively manage shifting deadlines and priorities; solid analytical skills
• Confident, professional demeanor; can-do attitude and desire to deliver great service
• Strong problem-solving skills with ability to process complex information, break it into logical steps/tasks to help solve the problem

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 recruiting@avantorsciences.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.

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