The Sr. Quality Specialist shall independently conduct and write complex formal investigation reports with input from area SMEs. The candidate will function as an independent reviewer of drafted investigations providing constructive feedback and in some instances act as a coach to the investigator. This position will also perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action. The incumbent will assist in the tracking and trending of corrective and preventative action to assure timely closure. This person will also perform reviews and evaluate sensitive, confidential information and develops recommendations for use by the plant quality assurance department.
In order of importance, list the primary responsibilities critical to the performance of the position. Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.
* 2-5 years’ experience in pharmaceutical quality environment required
* Experience in sterile manufacturing and an understanding of the sterilization process and its impact to products.
* Working knowledge of environmental monitoring and aseptic manufacturing.
* Understanding of process validation requirements.
* American Society for Quality (ASQ) certification is an asset.
* Pharmaceutical operations experience and/or knowledge. Experience in a solutions facility preferred.
* Working knowledge of FDA regulations.
* Knowledge of various quality tools such as root cause analysis, DMAIC process, fishbone analysis, etc.
* Prior investigation writing experience (with determination of product impact).
* Strong oral and written communication presentation, interpersonal skills and adept at communication with employees at all levels within the organization.
* Excellent facilitation skills and ability to facilitate strategy meetings.
* Superior technical writing and problem solving skills.
* Organize data, extract key information and write technical summary reports.
* Expertise with word-processing, spreadsheet, and presentation software. Track Wise experience a plus.
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate. Ability to interface with multiple levels of people in the organization, including plant personnel and senior management.
EDUCATION AND EXPERIENCE
Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
* Bachelor’s degree (science preferred) with 3-5 years’ experience in the FDA regulated industry. TECHNICAL SKILLS REQUIREMENTS Indicate the technical skills required and/or preferred, as applicable.