quality engineer
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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

Sep
18
Sandeep Singh Dhillon
Quality Engineer – Root Cause Analysis/Medical Device/Investigation from Randstad Engineering
Pharma Job Portal
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This Job is located in Marion, NC -> United States

About the Job

Global medical device manufacturer has an immediate need in Marion NC for a Quality Associate III- Investigation Owner. This is a perm position and offers relocation assistance for the right candidate. The deviation owner leads the investigation of deviations that occur in operations and is responsible for authoring the investigation summary report. Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause and corrective and preventive actions. Interacts will all levels of staff and provides status updates as well as present the strategy for closure of deviations. Manage several investigations at a time.

Responsibilities for the Quality Engineer

Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures. Determine appropriate preventive actions to avoid reoccurrence of the deviation
Conduct personnel interviews to determine root cause of the deviation
Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate
Set up and run meetings with cross functional teams
Close deviations in a timely manner to meet business and compliance needs
Work with Subject Matter Experts and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective and preventive actions, complete trending analysis, and recommend product disposition
Present and defend investigations during regulatory inspections, as required
Requirements for the Quality Engineer

Bachelor’s degree in science or engineering
2-3 years of experience in root cause evaluation, interpreting regulations and quality systems within the medical device or pharmaceutical indsutry
5-8 years of experience in Manufacturing Operations and or Quality, or related field in the medical products industry
Must have a thorough understanding of pharmaceutical manufacturing process and equipment, preferably parenteral solutions, and current Good Manufacturing Practices (cGMPs)
Must have good analysis, troubleshooting, and investigation skills
Must be able to put complex thoughts and issues into writing in such a manner than an educated, but uninformed reader can understand and make decisions based on the written investigation report

Apply at http://engineers.randstadusa.com/think.nsf/b2_apply1?openform&jt=Quality%20Engineer&ParentUNID=CC1F769477EDCE7A85258167006D17F2&frm=mon_kw&mdm=job%2Bpost&nme=Job%2BBoards&frm1=mon_kw