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The Manufacturing 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 Associate position will be focused on: Performing 100% manual inspection; Post inspection packaging operation; Characterization and equipment management; Process improvement projects/assignments within operations; Quality systems (LIMS/MES/SAP/MAXIMO) support; Support new product introduction activities; Support clinical and commercial production; Maintain open communication between operations teams. This Associate position will be focused on manual visual inspection in manufacturing operations.
Job Responsibility:
Performing 100% manual inspection
Post inspection packaging operation
Characterization and equipment management
Process improvement projects/assignments within operations
Quality systems (LIMS/MES/SAP/MAXIMO) support
Support new product introduction activities
Support clinical and commercial production
Maintain open communication between operations teams
Perform 100% manual inspection
Perform post manual inspection packaging operations
Under minimal supervision, performs manufacturing unit operations according to Standard Operating Procedures
Understand process parameters and can identify process anomalies
Operate critical processing equipment
Assist and implement continuous improvement solutions related to routine functions
Assist in ensuring operations are completed per manufacturing schedule
Resource related to processing operations on the manufacturing floor
Identify and propose solutions to complex problems
Responsible for identifying and communicating 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 hands-on training to others
Provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents
Applies research, information gathering, analytical and interpretation skills to problems of diverse scopes
Utilizes basic 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 off-shift and weekends)
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
Ability to understand processing methods for manufacturing area
Requirements:
High school/GED + 2 years biotech/pharma manufacturing/laboratory or manufacturing support work experience
Associate's + 6 months biotech/pharma manufacturing/laboratory or manufacturing support work experience
Bachelor's
Nice to have:
Experience with manual visual inspection in a GMP regulated environment
Experience with PAS X Werum software for electronic batch records
Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology
Demonstrated technical writing capability
Knowledgeable of manual visual inspection background or strong understanding of related disciplinary areas in bioprocessing
Demonstrated ability to work in a team
What we offer:
Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program or sales-based incentive plan