Sr Associate QA I

• Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems
• 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

High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Associate's + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Bachelor's + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience OR Master's

• Strong cGMP and GDP behaviors
• Experience in biotechnology or pharmaceutical plant start up
• Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
• Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
• Demonstrated experience with deviations records
• Experience supporting GMP testing laboratories
• Strong organizational skills and ability to manage multiple tasks at one time, ability to follow assignments through to completion and meet timelines
• Strong communication skills, both written and oral
• Demonstrated ability to work as a team player and independently

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible