Senior Associate Quality Assurance - PQA

Role Summary

Senior Associate Quality Assurance - PQA on-the-floor position supporting on-going bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations. The role focuses on real-time decision making to ensure adherence to GMP quality requirements and fosters partnership between Manufacturing and Quality staff for coaching and guidance on manufacturing events, deviations, and quality systems.

Responsibilities

• Support Quality Control Laboratories IQOQPQ, Equipment Qualification and Validation, perform quality review and approval of documents to support facility commissioning and qualification, according to project timelines.
• Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support.
• Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations.
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
• Identification and implementation of continuous improvement opportunities within our processes and systems.
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

Qualifications

• Required: High school diploma/GED and 4 years of Quality, manufacturing and/or other regulated environment experience OR
• Required: Associate's degree and 2 years of Quality, manufacturing and/or other regulated environment experience OR
• Required: Bachelor's Degree and 6 months of Quality, manufacturing and/or other regulated environment experience OR
• Required: Master's Degree.
• Preferred: Strong cGMP and GDP behaviors
• Preferred: Experience in biotechnology or pharmaceutical plant start up
• Preferred: Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
• Preferred: Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
• Preferred: Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
• Preferred: Demonstrated experience with deviations records
• Preferred: Experience supporting GMP testing laboratories.
• Preferred: Strong organizational skills and ability to manage multiple tasks at one time, ability to follow assignments through to completion and meet timelines
• Preferred: Strong communication skills, both written and oral
• Preferred: Demonstrated ability to work as a team player and independently