QA Coordinator

Avantor, a Global Fortune 500 company is looking for a dedicated QA Coordinator to optimize our Performance Materials organization.

This Paris, KY role is full-time, on-site; Monday through Friday 2:30- 11:00 PM.

Who you are:

Minimum Education Requirement:

• High School diploma/ GED

Required Experience (1 + yrs):

• Scheduling – Coordinating daily and weekend QA coverage to support production activities.
• Complying with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.
• Verifying / adherence to policies, procedures, and work instructions.
• Keeping 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.
• Ensuring that the work area is always in a state of “audit readiness”.
• Performing 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.
• Collaboration Skills (IE: Microsoft Office)
• Business level communication skills

Preferred Experience:

• Ensuring customer requirements are met.
• Reviewing production documentation for accuracy, completeness, and GDP compliance.
• Assisting in correcting order issues and ensuring actions taken are appropriate.
• Communicating issues / concerns to management
• Ensuring actions taken to resolve production issues and concerns are effective.
• Performing pre-fill, in-process, and final inspections with the aid of documented work instructions and inspection information
• Halting production when a non-conformance (NCM) is observed and following appropriate NCM procedures.
• Quality Assurance experience within the medical device, biotech, or pharmaceutical industry
• Knowledge of ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, or EXCiPACT standard

How you will thrive and create an impact:

The QA Coordinator will take part in:

• Investigations – 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.
• Validations – 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.
• Batch Record Review and Release – Assists with the review and release of batch records as needed to support on-time delivery; ensures GDP compliance.
• Documenting non-conformances following applicable Avantor procedures and work instructions.
• Ensuring cleanliness of work areas during the inspection processes.
• Assisting in the development and implementation of corrective and / or preventive actions.
• Utilizing problem solving tools such as 5M+E, 5 Why’s, or other root cause analysis tools / methods to identify and permanently resolve issues.
• Adhering to Avantor policies
• Walking the floor to observe, train, and facilitate / support change.
• Balancing multiple tasks and prioritizing efficiently
• Demonstrating the ability to lead others by example and provide direction
• Providing coaching and mentorship to QA Inspectors  since this is the initial point of contact for production issue resolution
• Performs other duties as assigned.

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 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!

Environment:

Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level. May also work in warehouse setting with appropriate protective wear if performing pre-fill, in-process, and final inspections on product.  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.

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.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

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.