What You’ll Work On
Partner with Operations as a Quality representative to review production records, executed test methods, and material disposition decisions before commercial distribution.
Review process and test method validation, equipment and facility qualification documentation, and calibration records; identify and resolve deficiencies before commercial use.
Support nonconformance and deviation investigations, assess process risks, recommend mitigations, and help improve manufacturing and quality processes.
Review and approve standard operating procedures and manufacturing work instructions, and conduct production-area audits to maintain compliance with cGMP, ISO, and internal quality standards.
Collaborate with cross-functional teams to resolve day-to-day quality concerns, maintain accurate documentation, and support continuous improvement.
Required Qualifications
Bachelor’s degree in engineering, science or a related field; or an associate degree in a related field with an additional two years of experience
2+ years of experience in a manufacturing operations environment
1+ years of experience applying quality principles and practices
Knowledge of and experience working within a 21 CFR Part 820, ISO 13485, and/or cGMP-regulated environment
Strong communication and collaboration skills with the ability to work effectively across Operations and Quality teams
Ability to meet applicable PPE requirements and perform role-related physical activities, including lifting up to 40 pounds, with or without reasonable accommodation
Authorization to work in the United States without sponsorship
Preferred Qualifications
2+ years of experience in biotechnology manufacturing, preferably in a GMP and/or ISO 13485 environment
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.
- The base pay for this position is
- $61,300.00 – $122,700.00
- In specific locations, the pay range may vary from the range posted.
JOB FAMILY
Operations Quality
DIVISION
APOC Point of Care
LOCATION
United States > Princeton : 400 College Road East
ADDITIONAL LOCATIONS
WORK SHIFT
Standard
TRAVEL
No
MEDICAL SURVEILLANCE
Not Applicable
SIGNIFICANT WORK ACTIVITIES
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
