Title: Sr. Quality Specialist
Location: Rocky Mount - NC
Duration: 18 Months
Job Description:
- 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.
Position Responsibilities
- 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.
- TrackWise experience a plus.