Senior Executive, Quality Assurance

The Opportunity:

The Sr. Officer- Quality Assurance is responsible to ensure that customer and regulatory requirements have been met by inspecting products and review of documentation throughout all aspects of the production process. Also to ensure compliance with all applicable standards and regulations, Good Manufacturing Practices (cGMPs), and Good Documentation Practices (GDPs). Provide Event and Complaint investigation support to other team members.

What We’re Looking For

• Education: Bachelors degree in Chemistry, Biology, or related field. Masters degree is a plus.
• Experience: Minimum 5 years of experience working in quality assurance or related role within the pharmaceutical, biotechnology, or chemical industries.
• Knowledge of ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, or EXCiPACT standard is preferred
• Demonstrated experience or knowledge in conducting root cause analysis as it relates to non conforming material investigations
• Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages

Investigation – Performs real-time risk assessment and sufficiently controls suspected non‑conforming finished products, raw materials, and/or packaging components. Provides Event and Complaint investigation support to other team members. Provides oversight to ensure appropriate segregation of non-conforming material and resolution to product to resolve customer product pipeline.

Validation – Supports equipment and product validation activities. Utilizes validation knowledge when assessing risk associated with internal events.

Training - Provides initial training to new QA Inspectors; assists other departments with necessary training that pertains to functional aspects of the Quality Management System (QMS). Develops, maintains, and routinely evaluates on-boarding requirements for QA Inspectors.

Audits – Leads Internal QMS Audits, conducts effectiveness audits, supports external customer and regulatory audits, and manages the Line of Sight / On the Floor Audit Program. Manages quality compliance on the production floor and is responsible for the communication and resolution within production areas with operations management.

• Scheduling – Coordinates daily and weekend QA coverage to support production activities.
• Batch Record Review and Release – Assists with the review and release of batch records as needed to support on-time delivery; ensures GDP compliance.
• Provides coaching and mentorship to QA Inspectors, and is the initial point of contact for production issue resolution.
• Complies with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.

Keeps customer interests and regulatory requirements in mind, ensures customer needs are met by reviewing order requirements, customer documentation requirements, proper filling and assembly requirements, and, where needed, ensures other technicians understand and follow documented VWR procedures and GMP requirements.

• Ensures customer requirements are met.
• Verifies adherence to policies, procedures, and work instructions.
• Reviews production documentation for accuracy, completeness, and GDP compliance.
• Assists in correcting order issues and ensures actions that are taken are appropriate.
• Communicates issues / concerns to area owner and direct manager.
• Ensures actions taken to resolve production issues and concerns are effective.
• Ensures that the area is in a state of “audit readiness” at all times.

Performs inspection tasks by following established work instructions and procedures, by using required tools and methods and; when applicable, equipment, to determine acceptability of product, components, and documentation.

• Performs pre-fill, in-process, and final inspections with the aid of documented work instructions and inspection information as required.
• Stops production when a non-conformance (NCM) is observed and follows appropriate NCM procedures.
• Documents non-conformances following applicable AMRESCO / VWR Solon procedures and work instructions.
• Documents and trends any quality production issues discovered during the course of inspection duties.
• Ensures cleanliness of work areas during the inspection processes.
• Initiates change requests to order documentation (bills of material) to resolve future production issues when necessary.
• Assists in the development and implementation of corrective and / or preventive actions.
• Utilizes problem solving tools such as 5M+E, 5 Why’s, or other root cause analysis tools / methods to identify and permanently resolve issues.
• Adheres to AMRESCO / VWR Solon’s QMS and VWR Policies, where applicable.
• Walks the floor to observe, train, and facilitate / support change.
• Performs other duties as assigned.

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 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 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