Infotree Global Solutions · 7 hours ago
MCS Senior Associate Quality Assurance (GMP) - Night Shift
Thousand Oaks, CA
Contract
Onsite
Senior LevelInfotree Global Solutions is seeking a Senior Associate, Quality Assurance (MCS) to provide real-time, floor-based QA support at Amgen’s USTO site. This fully onsite role involves rotating between day and swing shifts and supports Clinical/Commercial drug substance production, requiring cleanroom oversight and batch record review.
Human ResourcesStaffing AgencyTechnical Support
Hiring Manager
Abhey Abrol
Responsibilities
On the floor support giving PQA support for Manufacturing support
Record review and approval for BRRs, Deviations and SOPs
Qualification
Required
Must be flexible as it is possible worker will start on any shift
Rotate every 6 months
The position supports Clinical/Commercial drug substance production and requires cleanroom oversight, batch record review, and acting as a QA liaison during manufacturing and facility events
Ideal candidates will have hands-on QA or manufacturing experience in a GMP environment (preferably within biotech or Amgen) with strong critical thinking skills prioritized over academic credentials
The manager is open to training strong candidates but will not consider those who are purely academic or significantly overqualified without clear justification
This position supports Amgen's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas
Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems
Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations
Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion
The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment
Preferred
Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field
Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices
Ability to make Quality based decisions in order to ensure compliance
Experience managing projects through to completion & meeting timelines
Evaluating documentation and operations according to company procedures
Experience working with Quality Systems
Strong organizational skills and ability to manage multiple tasks at one time
Effective communication skills (both written and verbal)
Demonstrated ability to work as both a team player and independently
Display leadership attributes and drive improvement initiatives
Company
Infotree Global Solutions
Infotree Global Solutions is a talent management company specializing in staffing and payroll solutions.
Founded in 2002
1001-5000 employees
H1B Sponsorship
Infotree Global Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (9)
2023 (11)
2022 (17)
2021 (16)
2020 (19)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Kingswood Capital Management
2025-02-20Private Equity
Leadership Team
Matt Milano
Chief Executive Officer
Klaus Geiser
Chief Financial Officer
Recent News
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