Top 3 Must Have Skill Sets:
- Commissioning and Qualification
- Technical Writing
- Quality oversight
Day to Day Responsibilities:
- Review & approve documents
- On the floor oversight of activities
- Attend meetings & report metrics/ status
- Ideal candidate- 5+ years industry experience.
- Commissioning and Qualification experience.
- experience with CAPA, validation, Technical Writing.
- Quality oversight.
- Quality oversight of AR 30 startup activities for facilities, utilities, equipment, systems and process with alignment and integration into the Amgen Quality Systems, including:
- Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental qualification protocols/reports, validation protocols/reports.
- Oversee execution of and change management related to the following: factory acceptance, commissioning tests, facility qualifications and validation activities.
- 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 facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations.
- Oversee and provide guidance during on-the-floor analytical testing.
- Audit and inspection support
- 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.
- Assess changes that could potentially impact product quality.
- Provide management updates (via various reporting tools) on metric performance to goals and alert senior management of quality, compliance, supply and safety risks.
- Complete required assigned training for self, and ensure training of staff, to permit execution of required tasks.
- Perform training activities, as needed.