What are the responsibilities and job description for the QA Engineer position at Tech Tammina?
Job Title : QA Engineer
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.
Responsibilities
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
Keep a pulse on the job market with advanced job matching technology.
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