Pharmaceutical Quality Engineer Senior/ Quality Assurance Lead III (Scientific)
Ridgefield, NJ- Hybrid Role
12 Months Extendable contract
Pay Range: 70-80/Hr on w2 Hybrid type role, manager knows this is kind of two jobs in one. Quality engineer background is the most basic background they would need. Pharma background in manufacturing would be needed. Data manipulation and data trending. Can work with data sets. Write reports. Product and process trending. Environmental trending. Statistical trending. Aseptic manufacturing bonus. Microbiological background. Aseptic gowning. Would need someone with experience. Graphing and trending. Mini-tab experience is also a bonus. Might be doing walkthroughs of the facility. Manager will provide a lot of training as they realize the ask is a lot. Onsite full-time.
The Quality Engineer Senior role is part of the Quality Assurance group. Quality Assurance provides oversight of the systems and procedures governing the GMP activities at the Ridgefield facility including Production, Validation, Quality Control and all supporting departments.
Major responsibilities include but are not limited to:
• Perform Product and Process Trending, author reports and present at management review meetings.
• Perform trending of all environmental monitoring and process utility data author quarterly reports and escalate any issues or adverse trends to Senior Management.
• Calculate Contamination Recovery Rates (CRRs) for all Graded Manufacturing areas and personnel.
• Independently perform Quality Assurance walkthroughs of classified manufacturing areas to observe and evaluate production activities, aseptic processes and the proper execution of Batch Production steps, identify any deficiencies and escalate critical issue to Senior Management
• Lead the Alarm Reconciliation Program ensuring all facility Critical alarms generated are accounted for and proper root cause, corrective action, event assessment and trending is complete and accurate.
• Update Quality Assurance standard operating procedures as required
• Perform Gap assessments of corporate standards and guidance documents where required.
• Perform other Quality related tasks such as deviation investigations and GEMBA assessments when required
• Participate in programs for process improvements when required.
Basic Qualifications:
• Bachelor’s Degree and 5-10 years of relevant experience in Process trending and statistical control
Preferred Qualifications:
• Ability to multitask.
• Ability to work independently
• Ability to interact and present information to upper level management
• Working knowledge of Word, Excel, Minitab, PowerPoint or other data management applications
• Ability to establish and maintain highly effective relationships with individuals from all levels of the organization. •
Last updated on Jun 5, 2023