Sr Associate QA - Plant Quality Assurance (PQA) - Night Shift

Role Summary

Sr Associate QA Plant Quality Assurance (PQA) - Night Shift. On-the-floor role working with plant manufacturing and support groups for bulk drug substance manufacturing and new product introduction (development, clinical, and commercial operations). Provides real-time quality oversight to ensure adherence to GMP quality requirements and supports continuous improvement within processes and systems.

Responsibilities

• 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

• Basic Qualifications:
  • High school/GED + 4 years Quality, Manufacturing and/or other regulated environment experience OR
  • Associate‚Äôs + 2 years Quality, Manufacturing and/or other regulated environment experience OR
  • Bachelor‚Äôs + 6 months Quality, Manufacturing and/or other regulated environment experience
  • Master's
• Preferred Qualifications:
  • 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

Skills

• Quality oversight and regulatory compliance
• GMP/GDP and quality systems
• Analytical testing and on-the-floor support
• Deviations, CAPA, change control, and validation processes
• Project management and continuous improvement
• Effective communication and teamwork

Education

• As listed in Basic Qualifications: High school/GED, Associate‚Äôs, Bachelor‚Äôs, or Master‚Äôs degree in a related field or experience

Additional Requirements

• Shift flexibility to include late afternoons and nights for 24/7 operations