Quality Engineer - Investigations at ...
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Oct
13
Sandeep Singh Dhillon
Quality Engineer – Investigations at Nexgen Pharma, Inc Irvine, CA 92614
Pharma Job Portal
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About the Job
NexGen Pharma, Inc., a leader in quality pharmaceutical manufacturing and nutritional products for over 80 years. We provide a work environment that is fast-paced and entrepreneurial where our human capital is valued as the number one asset. We create success through a goal-oriented and goal-achievement atmosphere, surrounded by a committed staff and management team.

RESPONSIBILITIES:

Manage the problem analysis and corrective action/preventative action (CAPA) quality elements

Investigate and resolve non-conformances and deviations in a timely manner

Collate information, write justifications and manage the Continuous Quality Improvements program

Technical resource within the plant for problem solving, Non Conformances /CAPA system

Lead, perform and analyze the tracking and trending of Quality Events, Non Conformances, investigations and CAPA(s)

Manage the site Quality Event escalation program associated with lot or system disposition issues and Hold Events

Manage the day to day activities for the timely initiation, tracking and closure of Non Conformance and CAPA(s)

Perform statistical analysis of Quality Events data required for investigations

Assist manufacturing and other departments in identifying root cause and implementing effective corrective actions for those circumstances where quality standards are not met.

Train new personnel on the Investigations and CAPA system

Complete complaint investigations as requested and per timelines provided

Serve as back-up to Batch Records Auditor including, but not limited to identifying all lot non-conformances

Provide management periodic updates of Deviations and CAPA(s)

Perform other related duties as assigned

QUALIFICATIONS:

Bachelor’s Degree, preferably in Science, Engineering, Math, statistics, or equivalent combination of education and experience

12+ years of non-conformance investigation experience

12+ years of experience in GLP or GMP environment

Able to interpret GMPs and other government regulations

Able to coach and train new personnel on the Investigations and CAPA system

Knowledge of manufacturing/processing techniques, laboratory procedures, Root Cause Analysis and statistical applications is preferred

Must have strong written and verbal communication skills

ASQ, black Belt or Green Belt certifications is a plus

Must demonstrate initiative, innovation and sound analytical problem solving skills.

Able to build rapport with coworkers and partner with other departments

Apply at http://job-openings.monster.com/v2/job/apply?jobId=189083055



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