Specialist Quality Assurance Drug Product - Thousand Oaks CA
Company: Msccn
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization
works with partner companies to source qualified talent for their
open roles. The following position is available to Veterans,
Transitioning Military, National Guard and Reserve Members,
Military Spouses, Wounded Warriors, and their Caregivers . If you
have the required skill set, education requirements, and
experience, please click the submit button and follow the next
steps. Unless specifically stated otherwise, this role is "On-Site"
at the location detailed in the job post. Specialist Quality
Assurance - Drug Product What you will do Let’s do this. Let’s
change the world. In this vital role you will support the Plant
Quality Assurance program providing daily oversight of operational
activities associated with and supporting the aseptic Drug Product
manufacturing areas at Amgen, Thousand Oaks. Under general
supervision, the role provides support and compliance oversight to
Manufacturing and Facilities & Engineering staff in the
implementation of their processes, procedures, and use of quality
systems. Duties include ensuring timely delivery and completion of
records within our QMS, i.e. Deviations, CAPAs, Change Controls
etc. SOP revision, review and approval, work order approval. The
Specialist will also support tech transfers into the facility,
evaluate compliance issues, provide recommendations, and assure
progress of quality records to completion. The individual will also
represent the B20 Quality function of projects necessary to achieve
departmental and plant goals and will work in a dynamic cross
functional environment. Responsibilities Partner with our
colleagues in Manufacturing, Supply Chain, Facilities and
Engineering and Automation to maintain our strong culture of
Quality and Safety and ensure we continue to meet Amgen standards.
Provide Quality support to Tech Transfers into the Drug Product
facility. Provide Quality Oversight of the manufacturing facility
including manufacturing operations, testing, inspection and
utilities. Participates in and provides quality oversight for
quality records including Deviations, Change Controls, and CAPAs,
assuring adherence to procedural requirements and regulatory
expectations. Perform impact assessments as part of change controls
impacting production or QA processes. Provides quality expertise
and guidance to operational staff and within cross functional Amgen
teams. Reviews and approves controlled documents, including but not
limited to Standard Operating Procedures, Protocols and Reports.
Ensures that operations align with applicable regulations and Amgen
requirements relating to Good Manufacturing Practices, Good
Documentation Practices, Safety, and Controls. Contribute to and
drive continuous improvement projects in cross-functional
collaboration. Represent the Quality function and provide quality
oversight during the implementation of projects required to improve
and deliver our departmental and manufacturing plant goals.
Contribute to and drive digital innovation solutions and
applications in cross-functional collaboration. Supports or leads
Inspection Readiness for the facility. Participates in
internal/external audits and inspections and may directly interact
with regulatory agencies during on-site inspections Additional
Qualifications/Responsibilities What we expect of you We are all
different, yet we all use our unique contributions to serve
patients. The professional we seek is a dynamic employee with these
qualifications. Basic Qualifications: Doctorate degree Or Master’s
degree and 2 years of quality experience Or Bachelor’s degree and 4
years of quality experience Or Associate’s degree and 8 years of
quality experience Or High school diploma / GED and 10 years of
quality experience Preferred Qualifications: Bachelor’s Degree in
Science 5 plus years of aseptic processing experience in QA or
Manufacturing Excellent interpersonal, verbal and written
communication skills with all levels within the Organization Strong
level of analysis skills to evaluate and interpret information to
arrive at logical and quality-minded conclusions. Experience
applying problem-solving tools for root cause analysis. Strong
leadership capabilities and proven experience applying GMP
requirements in an operational setting Ability to independently
interact with various levels, drives tasks to completion, and is a
self-starter. Applies project management principles and techniques.
What you can expect of us As we work to develop treatments that
take care of others, we also work to care for your professional and
personal growth and well-being. From our competitive benefits to
our collaborative culture, we’ll support your journey every step of
the way. The expected annual salary range for this role in the U.S.
(excluding Puerto Rico) is posted. Actual salary will vary based on
several factors including but not limited to, relevant skills,
experience, and qualifications. In addition to the base salary,
Amgen offers a Total Rewards Plan, based on eligibility, comprising
of health and welfare plans for staff and eligible dependents,
financial plans with opportunities to save towards retirement or
other goals, work/life balance, and career development
opportunities that may include: A comprehensive employee benefits
package, including a Retirement and Savings Plan with generous
company contributions, group medical, dental and vision coverage,
life and disability insurance, and flexible spending accounts A
discretionary annual bonus program, or for field sales
representatives, a sales-based incentive plan Stock-based long-term
incentives Award-winning time-off plans Flexible work models where
possible. Refer to the Work Location Type in the job posting to see
if this applies. Salary Range 113,191.00 USD - 131,832.00 USD
Keywords: Msccn, Compton , Specialist Quality Assurance Drug Product - Thousand Oaks CA, Science, Research & Development , Thousand Oaks, California
