More jobs:
QA Engineer
Job in
Lebanon, Boone County, Indiana, 46052, USA
Listed on 2026-03-03
Listing for:
Tech Tammina
Full Time
position Listed on 2026-03-03
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Location:
Lebanon, IN
Job Description:
Qualifications
- BS in Engineering or science-related field.
- GMP manufacturing knowledge and/or experience.
- 2+ years manufacturing experience.
- Thorough technical understanding of quality systems and regulatory requirements.
- Demonstrated coaching and mentoring skills.
- Experience in root cause analysis.
- Demonstrated application of statistical skills.
- Experience in API or finished product manufacturing, QA or Engineering.
- Experience with system and equipment qualifications.
- Knowledge of cGMPs and quality systems.
- Demonstrated strong written and verbal communications skills.
- Strong attention to detail.
- Excellent interpersonal skills and networking skills.
- Ability to organize and prioritize multiple tasks.
- Demonstrated flexibility when faced with changing priorities.
- Proficiency with computer system applications and process automation systems.
- The Engineer - QA is responsible for providing technical guidance and leadership to the LP1 site regarding the quality standards employed to maintain and improve site operations
- The area of focus includes utilities, bulk distributed materials (BDMs), and facilities/equipment qualification
- Provide direct quality oversight of production, engineering, automation, and laboratory operations
- Review and approve documents including, but not limited to, procedures, change control proposals, deviations, and equipment/system qualification/validation
- Provide coaching, feedback and mentoring to engineering and QA as it relates to execution of quality systems
- Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems
- Conduct gap assessments of global requirements and ensure implementation of the governing standards
- Participate in and/or lead, support self-inspection activities and regulatory inspections
- Maintain and improve FUME quality systems
- Assist business partners in the interpretation of regulatory and corporate requirements
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