Top 3 Must Have Skill Sets:
Previous QA oversight of manufacturing, analytical and engineering activities; experience in investigations and quality systems process knowledge. (beginner to intermediate level of experience)
Biotech- quality assurance/manufacturing experience (insight into quality assurance) (beginner to intermediate level)
Ability to gather relevant information to understand and solve complex problems and make scientific risk-based decisions. (troubleshooting experience/problem solving/ to best provide a quality assurance concepts)
Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with peers, manufacturing partners, and management staff. This role requires a high level of communication as there are 20 people working over 5 shifts so the candidate will need to be able to effectively communicate what was done and be able to pick up and ask questions from the previous shift.
Day to Day Responsibilities:
Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing.
Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, and Corrective Action/Preventative Actions (CAPA) records.
Establish and enable LEAN practices.
Ensures that deviations from established procedures are investigated and documented per procedures.
Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
Alerts senior management of quality, compliance, supply and safety risks.
** The actual shift schedule is Sat, Sun, Mon 7pm - 7am. For training purposes during the first 2 weeks, the candidate will have to work a Mon - Fri 8am - 5pm schedule.
The Specialist will be responsible for Quality Oversight On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. Amgen’s Quality Assurance On-the-Floor position Shift 5 (3 days a week Saturday through Monday 7pm – 7am) provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regards to compliance and quality systems.
"This posting is for Contingent Worker, not an FTE"