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.