Senior Associate Manufacturing Thousand Oaks
Thousand Oaks, CA - USA
Job Summary
What you will do
Lets do this! Lets change the world!
The Manufacturing Senior Associate position is part of the Amgen Thousand Oaks Drug Product Supply organization. This is a manufacturing support role responsible for manual visual inspection team. This Senior Associate position will be focused on:
Characterization data and equipment management
Process improvement projects/assignments within operations
Quality systems (Deviations/CAPA/CAPA EV/LIMS/MES/SAP/MAXIMO) support
Support new product introduction activities
Support production
Maintain open communication between operations teams
This Senior Associate position will be focused on manual visual inspection operations.
Job Scope and Responsibilities:
Under minimal supervision performs manufacturing unit operations according to Standard Operating Procedures
May schedule operations for multiple functional areas
Understand process parameters and can identify process anomalies
Perform data analysis of critical process parameters
Operate complex critical processing equipment
Assist plan and implement continuous improvement solutions related to routine functions
Assist in ensuring operations are completed per manufacturing schedule which may include delegation of tasks
Primary resource related to processing operations on the mfg. floor
Identify and propose solutions to complex problems
Responsible for resolving problems during operations
Perform initial review of manufacturing procedures/batch records
Review revise and audit documents
Ability to perform computer operations (MES EBR MAXIMO LIMS and SAP Knowledge)
Provide process theory expertise and hands-on training to others
Own deviations/CAPA or provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents
Applies research information gathering and interpretation skills to problems of diverse scope
Utilizes project management skills to set project timelines and priorities based project objectives and ongoing assignments
Recognizes and escalates problems
Able to establish working relationships with others outside area of expertise
Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend)
Ability to understand apply and evaluate basic chemistry biology and physical principles as appropriate for the position
Organizational skills and an ability to perform assignments with a high degree of attention to detail
Written and oral communication skills. Technical writing capability
GMP knowledge with ability to interpret and apply applicable regulations
Additional Qualifications/Responsibilities
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Basic Qualifications:
Masters degree OR
Bachelors degree and 6 months of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories engineering facilities quality) OR
Associates degree and 2 years of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories engineering facilities quality) OR
High School Diploma/GED and 4 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories engineering facilities quality)
Preferred Qualifications:
Prior experience with lab equipment computers and intermediate mathematical skills
Significant experience with manual visual inspection in a GMP regulated environment.
Significant experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
Degree in Engineering Chemistry Biochemistry Biology or Computer Science with experience in biotechnology
Demonstrated technical writing skills
Strong knowledge of manual visual inspection or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
Demonstrated ability to work in a team
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 well 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.
Apply now and make a lasting impact with the Amgen team.
In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Salary Range
Required Experience:
Senior IC
About Company
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