Quality Control Chemist

Job Title: Sr. Quality Specialist/ Quality Control Chemist 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.
• 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. ORGANIZATIONAL RELATIONSHIPS:
• Ability to interface with multiple levels of people in the organization, including plant personnel and senior management. EDUCATION AND EXPERIENCE:
• Bachelor’s degree with 3-5 years experience in the FDA regulated industry. All your information will be kep t confidential according to EEO guidelines. With Regards, Abhishek Singh 650-399-0881 Clinical Recruiter Integrated Resources, Inc.