ONSITE: Hillsboro, OR

Main Purpose of the Position;

• Provide direct manufacturing Quality Assurance support for all GMP activities at HTO/HDC.
• Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support.
• Assure compliance with cGMP regulations, The Company’s standards, and applicable Regulatory and The Company’s standards.
• Resolve Quality Assurance issues and develop solutions for complex problems following cGMP regulations.
• Work independently within broad guidelines and policies.

Job Duties/Responsibilities:

• Provide Quality oversight to the manufacturing operations at HTO.
• Initiate and close quality event records and action/assessment records as required.
• Advocate for the mission of advancing and boldly championing diversity, equity, and inclusion
• Follow company policies and procedures.

Technical Duties/Responsibilities:

• Maintain a state of inspection readiness.
• Sign documents for activities as MQA as described by The Company’s policies, procedures and job descriptions.
• Review batch records in the Aseptic Operations, Inspection, and Packaging areas.
• Complete Additional Actions in the Discrepancy Management System as assigned.
• Interact with interdepartmental contacts on discrepancy assessment and resolution.
• Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product.
• Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
• Support process improvement initiatives.

Qualifications:

Education, Experience, Knowledge and Skills

• Bachelor`s or Master`s degree (preferably in Life Science or Engineering) with 4-7 years of experience in the pharmaceutical industry and at least 2 years in a quality role.
• In-depth industry experience in aseptic GMP Drug Product filling and quality oversight for manufacturing processes and discrepancy management.
• Ability to perform physical activity including, but not limited to lifting, standing for periods of time, and gowning into production space.
• Knowledge of cGMPs and Health Authority expectations.
• Experience reviewing manufacturing documentation.
• Ability to communicate clearly and professionally both in writing and verbally.

The hiring range for this position is $50 to $60 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on the candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.