Sr. Quality Specialist

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 (science preferred) with 3-5 years’ experience in the FDA regulated industry.

All your information will be kept confidential according to EEO guidelines.

With Regards,

Abhishek Singh

650-399-0881

Clinical Recruiter

Integrated Resources, Inc.