QA Technician

The Opportunity:

Avantor, a Global Fortune 500 company is looking for a dedicated Quality Assurance Senior Technician for our biopharmaceutical’s organization.

This Aurora, OH role is full-time on-site, Monday through Friday 3 – 11:30 PM with potential overtime.

Minimum Education:

• High School Diploma/ GED; bachelor’s degree preferred.

Required Experience (1+ yrs):

• Collaboration skills (IE: Microsoft Office)
• Quality software (IE: ETQ, SAP, LIMS).
• Record keeping skills.
• Ability to adhere to manufacturing procedures.
• Ability to follow standard operating procedures (SOPs) and accurately complete paperwork.
• Analytical/ problem-solving skills.
• Understanding of root cause analysis.
• Understanding of statistical sampling plans, and analysis of quality assurance data.

Preferred Experience:

• Business level interpersonal, oral and written communication skills
• Organizational skills
• Detail oriented
• Working effectively in a team environment

How you will thrive and create an impact:

Avantor® is a leading life sciences company and global provider of mission-critical products and services to the life sciences and advanced technology industries.  A GMP manufacturing facility, the Aurora, OH location specializes in manufacturing of biochemicals.

With the ability to adapt readily to change and manage multiple priorities the Quality Assurance Sr. Technician will:

• Provide support to our customers, quality management system programs (including cGMP and ISO), and the entire manufacturing operation.
• Play a vital role in helping Avantor achieve success through quality monitoring, modification, and continuous improvement.
• Inspect shipments, reconciles labels, review and release finished product and other paperwork.
• Reviews QC testing documentation and results for conformance.
• Confirm expiration dating and issue certificates of analysis for each lot.
• Review and approve/reject quality-related documents.
• Assist in planning, developing, and implementing quality assurance programs.
• Respond to customer requests, including but not limited to investigating complaints and completing required paperwork for corrective and preventive actions and associated follow-up.
• Assist in changing and maintaining ISO and cGMP paperwork
• Implement and oversee training.
• Ensure the quality requirements of all departments are being followed and are accurately documented.
• Complete preventative maintenance (P) calibration documentation files
• Manage out of service equipment
• Oversee/ assure validations are performed according to approved protocols and samples provided as requested.
• Interpret, understand and manage a variety of technical information.
• Prepare routine, technical, and special presentations/reports to staff and management.
• Oversee the writing and maintenance of owner process manuals.
• Coordinate and perform quality assurance system internal audits
• Investigate non-conformances and determine root cause analyses.
• Review current policies; determining and documenting any areas that may need quality improvements.
• Perform 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 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.