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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.
Sr Associate Manufacturing Deviation Owner Environmental & Contamination Control
What you will do
Let's do this. Let's change the world. In this vital role you will be accountable for end-to-end management of assigned deviation records, including investigation, documentation, and resolution, ensuring compliance with site procedures and regulatory expectations.
Responsibilities
Deviation Ownership & Execution
Demonstrated technical writer able to articulate complex events into concise and clear documentation that is inspection ready.
Advanced thinker who, with some oversight from management and mentors, is able to structure investigational workflows with cross-functional team members that help drive teams to sound, data-driven conclusions and advance deviation records forward.
Serve as the designated owner for deviation records (initial job scope may focus on Environmental and Contamination Control; however, scope can be across manufacturing events)
Ensure timely progression and closure of deviations
Maintain accountability for data integrity and completeness of records
Investigation & Root Cause Analysis
Define and execute investigation strategy
Conduct shopfloor observations and Gemba activities, including interviews
Develop, schedule, and execute root cause analyses (RCA) and ensure scientific justification of conclusions
CAPA Development & Effectiveness
Lead CAPA identification and development aligned with investigation outcomes
Support CAPA and Effectiveness Verification (EV) management activities
Cross-Functional Coordination
Work with various organizations across the site and network including the Contamination Control Lead, Contamination Control Network, process specialists, Quality Assurance (QA), QC / microbial experts, Process Development, and Facilities and Engineering.
Ensure appropriate functional input into investigations and decisions
Documentation & Decision-Making
Advance strategic decision making for deviation documentation updates
Ensure records meet QMS and SOP requirements
Support change control impact assessments where deviations trigger system/process changes
Regulatory & Inspection Interface
Act as SME during inspections for assigned deviations
Be prepared to defend investigation rationale and classification decisions
Participate in daily updates / inspector engagements when required
Data Analysis & Continuous Improvement
Provide inputs to:
Deviation trending
Data analysis for recurring issues
Identify and share opportunities for prevention strategies and contamination control improvements
Leverage AI and digital tools compliantly to streamline investigation processes
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
Additional Qualifications/Responsibilities
Basic Qualifications
High school diploma / GED and 4 years of manufacturing and/or operations experience
Associate's degree and 2 years of manufacturing and/or operations experience
Bachelor's degree and 6 months of manufacturing and/or operations experience
Master's degree OR
Preferred Qualifications
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education and experience or the equivalent
BS/BA or equivalent (science/engineering/psychology preferred)
2+ years of experience in the pharmaceutical industry
Experience applying AI or other digital tools to generate insights and streamline workflows
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
86,048.05USD -116,417.95 USD