Senior Quality Engineer at Sharp Decisions

Title :: Senior Quality Engineer

Location :: Hillsboro, OR 97124 (Looking for Only Local Candidate)

Pay :: $65.67/hr

The Opportunity:

You will perform quality oversight of qualification and validation activities associated with equipment, facility and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods.

• You will provide assessment and approval for changes that impact the validated state and/or require qualification/validation.
• You will review and approve a variety of documents to support qualification and validation activities, ensuring compliance with internal quality system requirements.
• You will provide input and quality oversight to qualification/validation exceptions/deviations.
• You will work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.

• Who you are:

• You hold a Bachelors degree with 5-10 years industry experience or equivalent qualifications
• You have biopharmaceutical or pharmaceutical industry experience in technical validation or quality validation, and strong technical knowledge of qualification and validation principles.
• You have an ability to interpret and relate quality standards for implementation and review.
• You have the ability to make sound decisions about quality and technical subjects.
• You exhibit sound knowledge of cGMPs or equivalent regulations.
• You have flexibility in problem solving and work hours to meet business objectives.
• You are able to quickly and consistently establish rapport and collaborate effectively with team members and partners.