CrawlJobs Logo
Amgen Logo Amgen · Quality Control

Senior Associate Quality Assurance / Aseptic Coach

United States, Thousand Oaks 86928.00 - 106536.00 USD / Year · Job Posted March 12, 2026

Job offer has expired

Job Link Share

Job Description

The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements.

Job Responsibility

  • Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments
  • Responsible for performing real-time aseptic oversight and coaching of filling activities on the manufacturing floor
  • Support real-time troubleshooting and triage with quality and aseptic compliance
  • Support quality related decision making involving non-routine interventions and documentation
  • Electronic batch record review
  • GMP Document (SOPs/FORMs) revision review/approval
  • Review and approval of electronic Maintenance documentation Work Order/Job Plans
  • Quality support and approval of minor deviations
  • Electronic Batch Record (MES) documentation revisions and approvals
  • Support predominantly second/third shift work
  • Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion

Requirements

  • High school/GED + 4 years of GMP experience
  • Associate’s + 2 years of GMP experience
  • Bachelor’s + 6 months of GMP experience
  • Master's

Nice to have

  • Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field
  • Experience with coaching, delivering feedback, and/or leadership
  • Familiarity with Drug Product aseptic processing requirements
  • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
  • Experience managing projects through to completion meeting timelines
  • Ability to evaluate 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
  • Solid understanding and application of aseptic behaviors and principles

What we offer

  • 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
Amgen - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Senior Associate Quality Assurance / Aseptic Coach

8 matching positions

Global Business Development Manager

SP Industries Inc., an ATS Company is seeking an experienced Global Business Dev...
Location
Location
United States , Warminster
Salary
Salary:
Not provided
atsautomation.com Logo
ATS Automation Tooling Systems Inc.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 7+ years of experience in pharmaceutical, biopharma, or life science capital equipment or system solutions, with a strong focus on aseptic processing and/or lyophilization
  • Proven track record of closing large, complex, multi million dollar pharmaceutical system deals with biopharma, biotech, diagnostics, or CDMO customers
  • Demonstrated ability to build and convert a global sales pipeline, including direct ownership of opportunity creation, deal progression, and bookings
  • Working knowledge of EU GMP Annex 1 and its impact on aseptic lyophilization system design, automation, contamination control, and customer requirements
  • Practical understanding of GAMP 5 principles, including computerized systems, controls, data integrity, and validation expectations in regulated environments
  • Experience selling or supporting fully integrated aseptic system solutions, including lyophilizers, automated loading/unloading, material handling, and associated system architectures
  • Ability to engage credibly with senior customer stakeholders across engineering, manufacturing, quality, and executive leadership
  • Experience operating in a player coach capacity, combining direct commercial responsibility with leadership of technical SMEs or solution specialists
  • Bachelor’s degree in engineering, life sciences, or a related technical discipline
  • Willingness to travel globally 30-50%
Job Responsibility
Job Responsibility
  • Own and drive global revenue growth across the aseptic and non aseptic lyophilization portfolio, with direct accountability for closing large, complex, high value pharmaceutical and biopharma capital equipment and system solutions
  • Define and execute the global commercial strategy for lyophilization systems, leveraging strong understanding of lyophilization cycle development, formulation considerations, CIP/SIP systems, and sterility assurance requirements to deliver differentiated, value based solutions
  • Serve as a senior commercial and technical authority across non-aseptic and aseptic filling and lyophilization, with strong working knowledge of EU GMP Annex 1, FDA expectations, cleanroom classifications, isolators/RABS, aseptic process simulations, validation strategies, and quality risk management
  • Lead the sale of fully integrated system solutions, including lyophilization, automated loading and unloading, material handling, controls, and supporting architectures—positioning SP as a total solution partner rather than a standalone equipment supplier
  • Apply practical knowledge of GAMP 5, computerized systems, and validation expectations to support compliant system design discussions, risk mitigation, and customer confidence throughout the sales process
  • Build, qualify, and actively manage a robust global pipeline, including ownership of forecasting, financial modeling, and business case development to support accurate revenue planning and strategic investment decisions
  • Personally engage senior customer stakeholders across engineering, manufacturing, quality, procurement, and executive leadership to influence complex buying decisions, support contract negotiations, and close strategic, multi site opportunities
  • Lead and develop a team of lyophilization commercial based subject matter experts, setting clear commercial priorities, driving accountability, and ensuring technical depth directly supports deal execution and customer success
  • Partner cross functionally with engineering, product management, project management, manufacturing, and service teams to shape commercially viable offerings, influence service strategies, and ensure end to end solutions meet customer, regulatory, and operational requirements
  • Maintain a strong understanding of biologics, vaccines, small molecule injectables, and sterile drug products, along with global outsourcing drivers, capacity constraints, and competitor capabilities impacting the lyophilization and aseptic processing market
What we offer
What we offer
  • We provide a wide range of innovative and high-quality scientific products that improve people’s lives
  • We offer a robust health and welfare benefits package that includes Life, Health, Dental, Vision
  • We offer 401(K) including company match, Paid Time Off annually + Paid Holidays
  • You will enjoy career Advancement Opportunities and Tuition Assistance to help you achieve your goals and continue your career growth
  • Fulltime
Read More
Arrow Right

Senior Associate Manufacturing (Operations Lead)

The Sr. Associate Manufacturing – Strategic Projects role offers the opportunity...
Location
Location
Ireland , Dun Laoghaire
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a science discipline
  • 5+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
  • Strong project management and organisational skills
  • Critical thinking skills
  • Negotiation and Influencing skills
  • Excellent verbal and written communication skills
  • Strong technical writing skills for GMP documentation
  • Decision Making skills and confidence to challenge others
  • Teamwork and coaching others
Job Responsibility
Job Responsibility
  • Function as the site interface between the Product Delivery Teams (PDT’s), and ADL Manufacturing operations
  • Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection
  • Develop, review and update Production, Engineering, Operating Procedures & training materials
  • Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing
  • Evaluate, plan, and implement solutions for process improvement opportunities both current and project related
  • Support scheduling and execution of Characterisation, Engineering and PPQ runs
  • Provide troubleshooting support throughout the project and on the floor during execution of activities
  • Hold people to account for delivery and behaviours within the Manufacturing Support team and associated with the project(s)
  • Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing
  • Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects
Read More
Arrow Right
New

Administrative Assistant

Location
Location
United States , Saint Louis
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Previous experience in an administrative or office support role preferred
  • Strong written and verbal communication skills
  • Excellent time management and organizational abilities
  • Proficiency with Microsoft Office Suite and office technology
  • Ability to handle confidential information with integrity
Job Responsibility
Job Responsibility
  • Manage schedules, appointments, and meetings
  • Prepare and edit correspondence, reports, and presentations
  • Answer and direct phone calls
  • respond to inquiries promptly and professionally
  • Maintain and organize files, both physical and digital
  • Assist with data entry and database management
  • Support event planning and coordination tasks
  • Order office supplies and maintain inventory
  • Collaborate with team members on special projects as needed
Read More
Arrow Right
New

Early Years And Oshc Educators

Are you looking for a work life balance in early years education? Newly qualifie...
Location
Location
Australia , Brisbane
Salary
Salary:
37.24 - 60.10 AUD / Hour
https://www.randstad.com Logo
Randstad
Expiration Date
June 17, 2026
Flip Icon
Requirements
Requirements
  • Qualified or working toward your Certificate III in Early Childhood Education and Care, Diploma or Bachelor
  • Unqualified work in OSHC but must have experience working with children
  • Transport or access to Public tranaport and a willingness to travel to different locations around your area
  • Motivation to work with children to implement quality, engaging, and activity-based programs
  • An understanding of the Early Learning Framework
  • Australian work rights and a willingness to gain your Working With Children Card
  • Cert 3
  • Diploma
  • Bachelor or unqualified for OSHC but must have experience working with children
What we offer
What we offer
  • flexible hours
  • access to your pay when you need it
  • choose when and how you work via our app
  • ECEC retention payment for shifts at approved centres
  • discounts on petrol, groceries, food delivery, entertainment
  • Fulltime
Read More
Arrow Right
New

Filling Operator - Day shift (T line)

Location
Location
Canada , Alliston
Salary
Salary:
26.55 USD / Hour
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Successful completion of High School diploma or GED required (Proof will be requested)
  • Must pass ergonomic assessment to ensure ability to perform bonafide essential job duties
  • Experience doing repetitive tasks
  • Manufacturing/Quality experience in a GMP environment
  • Experience in food or manufacturing industry
  • Previous experience working in a fast-paced environment (experience working in an assembly line setting is preferred)
  • Flexibility to weekends
  • Positive attitude, and an ability to work in a team setting with a focus on quality assurance and attention to detail.
Job Responsibility
Job Responsibility
  • Visual Inspection of IV bag assembly
  • Filling IV solution in various bag sizes
  • placing bags into protective over-wrap
  • loading bags onto sterilizer trays
  • Using scales, weigh filled bags at regular intervals to ensure proper fill volume
  • Visually inspect each filled bag assembly for proper fill volume, air volume, code number, expiration date, lot number, and other quality characteristics
  • Pick up filled bag assembly from conveyor, position bag in over wrapper spec
  • Load over-wrapped bag into sealing machine
  • Load sealed over-wrapped assemblies onto sterilizer trucks ensuring proper number of samples and proper positioning
  • Perform necessary inspections including quality checks throughout each step-in process
What we offer
What we offer
  • Employee Stock Purchasing Plan
  • Defined contribution pension plan
  • medical/dental benefits on your first day
  • Fulltime
Read More
Arrow Right
New

Administrative Assistant

We are looking for an Administrative Assistant to support daily office operation...
Location
Location
United States , Baton Rouge
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Previous experience in an administrative assistant, receptionist, or general office support role
  • Proficiency with Microsoft Office Suite, including Word, Excel, and Outlook
  • Strong verbal and written communication skills with a detail-oriented approach
  • Ability to manage inbound calls, multitask effectively, and stay organized throughout the day
  • Accurate data entry skills and strong attention to detail
  • Availability to work on-site Monday through Friday in Baton Rouge, Louisiana
Job Responsibility
Job Responsibility
  • Manage day-to-day administrative tasks to keep office operations organized and running efficiently
  • Welcome visitors, oversee front desk activities, and create a positive first impression for the office
  • Answer incoming calls, direct inquiries appropriately, and relay messages in a timely manner
  • Prepare, update, and maintain documents, spreadsheets, and records using Microsoft Office applications
  • Enter and verify data with accuracy while supporting reporting and general recordkeeping needs
  • Coordinate schedules, assist with correspondence, and provide administrative support to internal staff as needed
  • Handle routine office duties such as filing, organizing materials, and maintaining an orderly workspace
What we offer
What we offer
  • Medical, vision, dental, and life and disability insurance
  • 401(k) plan
  • Free online training
  • Fulltime
Read More
Arrow Right
New

Hr Waste Management Driver

We are seeking experienced and highly skilled HR Waste Management Drivers to joi...
Location
Location
Australia , Rocklea
Salary
Salary:
46.88 AUD / Hour
https://www.randstad.com Logo
Randstad
Expiration Date
June 18, 2026
Flip Icon
Requirements
Requirements
  • A current and valid HR (Heavy Rigid) licence or above is mandatory
  • Proven previous experience operating Front Lift and Rear Lift waste management trucks is essential
  • A solid understanding of driving in and around Brisbane and the greater surrounds
  • Comfortable with early morning starts and the physical nature of the role, which involves bin maneuvering
  • Must be able to pass a pre-employment Drug and Alcohol (D&A) test
  • Valid HR Licence
  • Valid Work Rights
Job Responsibility
Job Responsibility
  • Operating Front Lift and Rear Lift trucks (often referred to as 'Garbo' or 'Dustbin' trucks)
  • Collecting commercial and residential waste bins across assigned routes in the Brisbane region
  • Operating the hydraulic lift mechanism and performing manual intervention (pushing/pulling of wheelie bins) to position them for loading
  • Maintaining a high degree of safety awareness and good judgment when identifying safe bin pickup locations
  • Fulltime
Read More
Arrow Right
New

Corporate Operations Leader

We are seeking a highly driven and strategic Corporate Operations Leader to mana...
Location
Location
Salary
Salary:
Not provided
aramex.com Logo
Aramex
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong leadership and ownership mindset with the ability to drive end-to-end initiatives
  • Excellent analytical and problem-solving skills with a data-driven approach
  • to have a good knowledge of Power BI, data visualization, and performance tracking
  • Familiarity with AI tools, automation, and digital transformation concepts
  • Strong understanding of logistics, last-mile operations, and fleet management
  • Product-oriented mindset with the ability to translate operational needs into system improvements
  • Effective stakeholder management and cross-functional collaboration skills
  • Strong communication and presentation abilities
  • Ability to manage multiple priorities in a fast-paced, dynamic environment
  • High attention to detail with strong follow-up and execution capabilities
Job Responsibility
Job Responsibility
  • Act as the business owner for Fleet Rollout and support in Champion application Rollout ensuring alignment with operational needs
  • Define business requirements, enhancements, and support product roadmap development
  • Monitor application performance, usability, and adoption across markets
  • Coordinate with product and Digital teams to resolve issues and implement improvements
  • Drive user adoption through structured rollout plans, training, and continuous feedback loops
  • Develop and manage crowdsourcing strategies to ensure scalable capacity
  • Identify opportunities to expand fleet supply while maintaining cost efficiency
  • Define, track, and monitor key operational KPIs such as SLA, utilization, cost per delivery, and courier performance
  • Develop performance dashboards and reporting tools using Power BI
  • Analyze performance trends and identify improvement opportunities
Read More
Arrow Right