Quality Engineer - Pharma/CAPA's
Quality Engineer - Pharma/CAPA's
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Job Description
Work for a specialty chemical manufacturer to theAutomotive Aerospace & pharmaceutical industries
Summary Quality Engineer CAPAS/Batch Records/Investigations
Under general supervision develop modify apply and maintain quality evaluation and control systems/protocols. Devise and implement methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment. Design and analyze inspection and testing processes mechanisms and equipment. Conduct quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks.
Job Duties:
Responsible for Quality System maintenance.
Performs root cause analysis and implementation of corrective action for process related issues.
Identifies statistical methods relevant to the manufacturing process.
Responsible for continual improvement activities to enhance the Quality System.
Develops and performs training to build quality awareness throughout the company.
Collaborates with Manufacturing Research and Development and Engineering to ensure transfer of newly developed products that are in accordance with approved data and analysis.
Conducts audits including closing out audit findings creating audits finding reports and works with multifunctional teams to determine proper corrective and preventive actions.
Assists in creation and maintaining quality documentation.
Implements and maintains Statistical Process Control (SPC) for products and identifies potential process improvements.
Conduct Active Pharmaceutical Ingredient product review.
Evaluate impact of process improvement effort and manufacturing deviation on process validation and product design.
Demonstrates good communication and project management skills.
Collaborate with team members to support company goals.
Develop experiments by applying full and fractional factorial techniques.
Assist in validation processes including TM validation manufacturing process validation cleaning validation
Knowledge of ISO 9000/ AS9100.
Knowledge and experience with LEAN Six Sigma methodologies.
Familiarity in Design of Experiments (DOE) and ability to lead implementation of improvements.
Proficiency working with Microsoft Excel Word.
Experience with Minitab or other statistical software strongly desirable.
Understanding of statistical process and quality control principle.
Skilled in metrology tools.
Ability to work optimally in a team environment.
Ability to identify problems and communicate solutions in a constructive and positive manner.
* Attention to detail; excellent organizational and record keeping skills.
Qualifications:
Bachelor of Science degree in Chemistry Chemical Engineering Material Science or related field required.
35 years experience in quality engineering role in chemical rubber or plastic industries preferred.
ASQ Certified Quality Engineer or are currently pursuing certification preferred.
GMP experience preferably in Pharma
Synerfac Technical Staffing
Employment Type
Full-Time
