Job Title: Quality Assurance Senior Associate- Biotech/ Pharma experience (JP10112) Location: Thousand Oaks, CA Employment Type: Contract Duration: 18 months with likely extensions Job posting date: 4/21/2022 Rate: $28-32/Hr W2 Note: Onsite Essential, must be able to work swing, morning, evenings, night shift (24/7 Operation building). Once trained it will 4-day work week.
3 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
3 workers required for this role
Biotech/ Pharma experience required.
The Senior Associate QA role supports Amgen’s Quality Assurance program, providing daily oversight of Drug Substance manufacturing facilities at Amgen Thousand Oaks.
Under general supervision, the role provides support and compliance oversight to MFG and F&E staff in the execution of their processes, procedures, and use of quality systems.
Duties include purposeful presence on the manufacturing floor, batch record review, SOP and MP revision approval, work order approval, and quality approval of deviations and CAPAs.
Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment to ensure workplace safety.
This staff member will be assigned to provide quality support during either day or night shift schedule periods, as operation support is 24/7.
Excellent verbal and written cross functional communication skills
Must have biotech/pharma manufacturing, quality assurance, or quality control experience.
Purposeful presence on the manufacturing floor (80% of working time spent on MFG floor in controlled, classified cell culture and protein purification areas).
Batch record review
SOP and MP revision approval
work order approval
quality approval of deviations and CAPAs
Safety auditing and observational work
No biotech/pharma manufacturing, quality assurance, or quality control experience
Unable to work shifts including morning, evening, or potentially nights
Inability to effectively communicate across broad and diverse teams
Interview Process: Phone Screens In person virtual interviews
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.