Quality Control Associate

Quality Control Associate#26-08179 Hillsboro, OR All On-site Job Description This position is part of the consolidated analytical development team responsible for supporting the development of new modalities in the newly created Pharma Technical Cell and Gene Therapy (PTC) organization, the position is based in Hillsboro, Oregon. PTC focuses on the development of cell and gene therapies for the treatment or cure of various diseases. In this role, you will perform analytical development and quality control (QC) activities in support of the cell and gene therapy produced at HIT. As a member of the Hillsboro Innovative Therapies (HIT) Analytical Development Quality Control (ADQC) team, you will be implementing various analytical methods to enable the manufacturing of cell and gene therapeutics. You will perform QC operations according to established processes to ensure production consistency and product quality. This role requires close partnership with technical development teams (TDTs), other PTC functions, PTD, and global teams to achieve speedy clinical proof of concept and readiness for commercial production. Responsibilities include validation, qualification, transfer and troubleshooting of analytical methodologies, support and execution of analytical testing related to process development, cleaning validation, investigations, extended characterization, in-process controls, and product release. Additional responsibilities include qualification of laboratory instruments and equipment, and validation of computer systems.

Responsibilities:

• Execute analytical method validation, and implementation in partnership with interdepartmental site colleagues and intradepartmental network colleagues to support GMP production at HIT
• Implement and use SOPs, specifications, and testing methods in full compliance with cGMP regulations and evolving expectations
• Embody PharmaTechnical lean principles and methods while fostering a continuous improvement mindset throughout the organization by practicing experimentation and learning
• Develop new business processes to constantly improve ourselves
• Perform analytical activities (e.g., assay transfer and assay validation) to meet project timelines
• Write or review equipment qualification/maintenance life cycle, method implementation documents (protocols and reports) and procedures with input from senior team members
• Perform technical review of data and assess against established acceptance criteria
• Identify gaps, technical problems, deviations and discrepancies
• Participate in project teams and process improvement initiatives
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• Perform a broad variety of basic and moderately complex tests with documentation according to cGMP
• Receive and provide training
• Perform equipment qualification / maintenance
• Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures
• Support the maintenance and compliance of operational areas
• Support internal and external audits and regulatory inspections
• Work to meet schedules, timelines, deadlines
• Perform environmental and critical utility monitoring, including sample collection, evaluation and result reporting
• Perform any other tasks as requested by Management to support analytical activities

Qualifications/Requirements:

B.S./B.A.

Degree and two years of experience or Master's degree plus one year experience or an equivalent combination of education and experience. Degrees are preferably in Chemistry, Biochemistry, Molecular Biology or relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry.

• Sound knowledge of cGMPs or equivalent regulations.
• Demonstrated ability to work independently to accomplish tasks
• May be required to sit at a computer terminal or laboratory bench for extended periods
• Strong verbal and written communication skills, ability to organize and present information both formally and informally
• Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures
• Ability to interpret and relate Quality standards for implementation and review
• Flexibility in problem solving and work hours to meet business objectives
• Work in an office and laboratory environment. Prolonged periods of standing/sitting at lab bench top. Frequent lifting (up to 25lbs), bending, reaching, twisting. Use of stepladders and pushcarts required
• Pass visual screening, as required
• Ability to travel to other sites, as required

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EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."