A producer of specialty pharmaceutical products is currently seeking a Senior Quality Engineer in the Colombus, OH area. This is a 6-month CONTRACT assignment. No per diem available.
Responsibilities for the Quality Engineer
Champion specific product lines for compliance from raw material to packaged product. Actively participate and drive improvement activities as required. Assure deployment of appropriate validation planning and robust design transfer. Apply subject matter expertise in Process Excellence, 6 Sigma, and CQE tools where appropriate
Review, evaluate and endorse investigation documentation for incidents and deviations. Provide QA support to manufacturing departments. Evaluate and update existing SOP’s for cGMP compliance. Facilitate, coordinate and champion investigations.
Perform and participate in MRB investigations. Participate in and perform internal cGMP audits. Communicate and determine disposition for quality issues within the facility. Participate in the Annual Product Review report process. Develop and maintain metrics / trending for incidents, deviations and CAPA items
Assist in the application of appropriate quality technology tools to establish and maintain process capability and to resolve deviations and non-conformances.
Requirements for the Quality Engineer
Four-year technical BS degree in a related field and 5+ years of technical experience in medical device or pharmaceuticals (includes QA or engineering experience).
Minimum of three years experience in a cGMP and/or other manufacturing environment.
Randstad is a $22.5 billion global provider of HR services and the second largest staffing organization in the world. From temporary staffing to permanent placement to in-house, professionals, search & selection, and HR Solutions, Randstad holds top positions around the world and has approximately 31,100 corporate employees working from its nearly 4,700 branches and in-house locations in 40 countries.
We are a company built on a deep network of expertise that crosses industries and geographies. We recognize that talent comes in different forms, that every business has its unique challenges and opportunities. And our recruiting experts are skilled at marrying talent and business—identifying the ideal professionals for an organization’s culture and its teams, its needs and its goals.
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