Description
Contract Operations Quality Assurance Specialist
This position 100% onsite only in Austin TX.
FLSA Status: Exempt
Position Summary:
The Contract Operations Quality Assurance specialist will primarily review and approve high, medium, and low- level events from contract operation sites for ICU. Assist with the review and approval of impact risk assessments and track associated corrective and preventative actions (CAPA's) to assure timely closure. This position will also be overseeing the change controls from contract sites.
Essential Duties & Responsibilities:
•Facilitate and participate in the investigation teams created to determine/assess root cause of exception reports and laboratory investigation reports, while serving as the liaison between Quality, Operations, and Regulatory / Compliance
•Review change controls received from contract manufacturing impacting ICU products. As required, coordinate with Austin site SME's to assess the impact of the changes
•Initiate Notification to Management upon receipt of deviations or Quality Notifications from contract manufacturing sites and other ICU support organizations, as needed.
•Participate in meetings with contract manufacturing sites and other ICU support organizations from Pfizer to discuss any open investigations, Out of Specifications, Change Controls etc.
•Overseeing the change controls from contract sites
•May be required to fill for review of internal events, as needed.
•Lead and/or support projects as assigned.
•Perform other related duties as assigned or required.
Knowledge, Skills & Qualifications:
•Working knowledge of FDA regulations.
•Strong oral and written communication skills.
•Strong interpersonal skills with ability to interface with multiple levels of people in the organization, including plant personnel and outside service providers.
•Excellent facilitation/presentation skills and ability to facilitate strategy meetings.
•Expertise with word-processing, spreadsheet, and presentation software.
Education and Experience:
•Bachelor's Degree required (Chemistry, Biology, Microbiology, or Engineering preferred).
•4-6 years' experience in Quality Assurance, Manufacturing, Engineering, or R&D functions or any combination, or a master's degree and 2 years' experience.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.