(QA) Quality Engineer - (REF7063F)

(QA) Quality Engineer - (REF7063F)

Vacancy expired!

Job Description

Quality will lead in the implementation of quality assurances practices, process control, change control, and Corrective and Preventive Action activities. This position is embedded in the Operations Work Stream. The Quality Engineer will partner with Operations and is the primary point of contact for all Quality decisions affecting daily activities.

The Quality Engineer will approve investigations, deviations, change controls, and in-process control improvements. In addition they will evaluate and recommend process changes to improve the Value Stream performance and regulatory compliance.

The Quality Engineer will act as an effective leader in promoting quality disciplines, decisions and practices, and will apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.

Key Responsibilities:
Evaluate aseptic practices and coach / mentor operations on improving aseptic operations
Provide Quality input to all investigations, deviations, change controls, SOP’s, and in-process controls in support of the assigned Value Stream(s).
Enable collaborative relationships between Operations and Quality with the overall focus of improving customer satisfaction.
Troubleshoot process issues and support inter-department teams in the resolution of process issues and quality problems.
Work closely with Operations, R & D, Purchasing, and Engineering to improve quality while reducing material scrap and costs.
Champion continuous improvement and the transition to a Lean Manufacturing Environment.
Drive quality management focus on productivity improvements throughout the business unit.
Work effectively as a member of cross-functional teams.
Drive Customer complaints to resolution; Serve as Quality Representative for all quality-related corrective/preventive actions within the Value Stream.
Support PPI activities at the site including Kaizen events. Supports Operations and Quality team members on process improvement activities.
Analyze trends and collaborates with manufacturing to investigate trends, conduct root cause analysis and lead corrective actions for processes and products.

Qualifications

• Qualified candidates will possess a Bachelor’s degree in related field along with 2 plus years related industry experience.
• Candidates must have excellent verbal communication and technical writing skills.
• Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
• Familiarity with many aspects of validation is expected.
• Experience with temperature mapping.
• Proficient in Microsoft Word, Excel, Power Point and Project.
• Must be willing to travel regionally and/or nationally throughout the US.

Additional Information

All candidates must be legally eligible to work in the United States.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.