CrawlJobs Logo

Quality Assurance Senior Associate, Drug Substance Plant

United States, Thousand Oaks 86928.00 - 106536.00 USD / Year · Job Posted March 04, 2026
Apply Position
Job Link Share

Job Description

In this role as Senior Associate QA, you will be responsible for providing quality oversight to Drug Substance manufacturing facilities at Amgen Thousand Oaks, working within a shift system. Under general supervision, you will support and ensure compliance for Manufacturing, Facilities, and Engineering staff in their processes, procedures, and use of quality systems. You will engage directly with a diverse range of partners, establishing effective working relationships with production operators, line leads, shift supervisors, warehouse staff, facilities, maintenance, and engineering teams. This role requires your local presence at the Amgen Thousand Oaks (ATO) site. This is a Sunday-Wednesday schedule and requires availability across the three different shifts (with rotations every 6 months): Day Shift, Swing Shift, and Night Shift.

Job Responsibility

  • Provide daily guidance and support to Production staff on compliance with Standard Operating Procedures (SOPs) and Work Instructions
  • Maintain a strong presence in Drug Substance (DS) areas to oversee GMP operations and quality systems
  • Serve as the first point of contact for quality-related production queries during DS operations
  • Lead, mentor, and coach Operations and support personnel on quality matters, fostering a strong Quality culture at the site
  • Review and approve batch production records and other GMP documentation to support daily operations
  • Compile and review batch records for manufactured lots in preparation for batch disposition
  • Own, review, and approve controlled documents, including SOPs, Work Instructions, and Forms
  • Collaborate effectively within a team matrix environment
  • Work across a three shift rotation including night shift

Requirements

  • High school/GED + 4 years quality assurance work experience
  • Associate’s + 2 years quality assurance work experience
  • Bachelor’s + 6 months quality assurance work experience
  • Master's
  • Quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor’s Degree in a Science Field
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment

Nice to have

  • Quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor’s Degree in a Science Field
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment

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
  • Flexible work models where possible

Looking for more opportunities?

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

Similar Jobs for

Quality Assurance Senior Associate, Drug Substance Plant

8 matching positions

Associate Director Quality Assurance

Responsible for providing oversight and leadership for Quality on-the-floor and ...
Location
Location
Singapore , Singapore
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 2 years of directly related experience OR Master's degree and 6 years of directly related experience OR Bachelor's degree and/or 8 years of directly related experience AND Good understanding of IS system compliance with hands on experience of Computer System Validation or Compliance
  • 10 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems
  • Direct experience with bulk manufacturing of biopharmaceuticals preferred
  • Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
  • Your selection for this role will be subject to fulfilling the medical requirements of this job scope
Job Responsibility
Job Responsibility
  • Ensuring Quality Assurance support for all ASM1 manufacturing activities (including on-the-floor quality oversight, batch record review, quality records approval)
  • Support routine GMP Oversight activities (e.g. SOPs, logbooks, reports) and ensure key performance indicators meet targeted metrics
  • Ensure required Quality resources are available to support commercial operations
  • Inspection Readiness and Support
  • Participate in root cause investigations for complex and significant exceptions or issues, leveraging various root cause analysis tools
  • Support site/network driven QA continuous improvement initiatives/activities
  • Escalate significant quality issues to Quality Management in a timely manner
  • Act as delegate to Quality Assurance Director when required to support business needs
  • Support Drug Substance Alignment Meetings for Functional areas
  • Providing guidance to the team
What we offer
What we offer
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Fulltime
Read More
Arrow Right

Pharmacy Intern

You’ve invested a lot of time and energy in your education. Now you want the cha...
Location
Location
United States , La Habra
Salary
Salary:
16.00 - 22.00 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
August 31, 2026
Flip Icon
Requirements
Requirements
  • Active Pharmacy Intern License in the state in which you are employed
  • Not on the DEA Excluded Parties List
  • No pending felony charges or convictions for criminal offenses involving controlled substances
  • Current enrollment in a School of Pharmacy
Job Responsibility
Job Responsibility
  • Participates in all aspects of the prescription filling process
  • Providing Patient Counseling
  • Collaboration with all Healthcare Professionals to provide coordinated patient care
  • Offering Health Screenings and Immunizations when appropriate
  • Customer Service
  • Patient Safety
  • Assisting Pharmacy Patients and Front Store customers with questions
  • Pharmacy Professional Practice
  • Regulatory Requirements
  • Inventory Management
What we offer
What we offer
  • Full range of medical, dental, and vision benefits
  • 401(k) retirement savings plan
  • Employee Stock Purchase Plan
  • Fully-paid term life insurance plan
  • Short-term and long term disability benefits
  • Well-being programs
  • Education assistance
  • Free development courses
  • CVS store discount
  • Discount programs with participating partners
  • Parttime
Read More
Arrow Right

Pharmacy Intern

You've invested a lot of time and energy in your education. Now you want the cha...
Location
Location
United States , Staten Island
Salary
Salary:
20.75 - 25.25 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
September 05, 2026
Flip Icon
Requirements
Requirements
  • Accepted into or actively enrolled in an ACPE accredited college or school of pharmacy
  • 0-3 years relevant work experience
  • Must possess or be in process of obtaining valid intern and/or technician licensure as required
  • Strong communication and presentation skills
  • Complete all required training within state guidelines and required timeframe
  • Have regular and predictable attendance, including nights and weekends
  • Be mobile and remain upright for extended periods of time
  • Lift, scan, and bag items
  • Finger Dexterity: Picking, pinching, typing or otherwise working primarily with fingers rather than whole hand or arm
  • Reach overhead
Job Responsibility
Job Responsibility
  • Lead with Heart – display empathy and compassion for your patients, customers, caregivers, and colleagues on your team
  • Seek new ways to grow, collaborate with others, and deliver better outcomes
  • Align others around our purpose to bring your heart to every moment of your health and gain support and commitment
  • Facilitate a team culture that promotes caring, energy, enthusiasm, and pride
What we offer
What we offer
  • dental
  • vision
  • wellness resources
  • employee discounts
  • access to certain voluntary benefits
  • Parttime
Read More
Arrow Right

Individual Needs Assistant

Do you want to help children reach their full potential? Do you have a passion f...
Location
Location
United Kingdom , Bognor Regis
Salary
Salary:
20958.00 - 24843.00 GBP / Year
https://www.randstad.com Logo
Randstad
Expiration Date
July 14, 2026
Flip Icon
Requirements
Requirements
  • Relevant Teaching Assistant experience (Must be able to provide references)
  • Relevant knowledge of the current national curriculum
  • Eligibility to work in the UK
Job Responsibility
Job Responsibility
  • Supporting learners on a 1:1 and small group basis
What we offer
What we offer
  • Accessible Public transport links
  • School hours/term time only
  • Permanent position
  • Top of the range technology and resources
  • Supportive Senior leadership
  • Brilliant career progression opportunities
  • Welcome bonus
  • Fulltime
Read More
Arrow Right

Inside Sales Representative

Robert Half has a new direct-hire opportunity for an Inside Sales Representative...
Location
Location
United States , Annapolis Junction
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or equivalent required
  • associate's or bachelor's degree preferred
  • 2+ years of inside sales, customer service, account management, or related experience
  • Strong communication and interpersonal skills
  • Ability to learn and retain detailed product knowledge
  • Excellent organizational and time-management skills
  • Proficiency with CRM software, Microsoft Office Suite, and business communication tools
  • Customer-focused mindset with strong problem-solving abilities
  • Must be legally authorized to work in the United States.
Job Responsibility
Job Responsibility
  • Manage and maintain assigned customer accounts through phone, email, and virtual communication
  • Develop strong working relationships with customers by providing responsive and professional support
  • Process customer inquiries, quotations, orders, and account-related requests
  • Monitor customer purchasing activity and identify opportunities to improve service and account performance
  • Coordinate with internal departments to ensure timely order fulfillment and customer satisfaction
  • Maintain accurate customer records and account activity within the CRM system
  • Become a subject matter expert on company products, applications, features, and benefits
  • Provide customers with product recommendations based on their business needs and requirements
  • Educate customers on product specifications, availability, pricing, and usage
  • Support customers with technical and product-related questions, escalating complex issues when necessary
What we offer
What we offer
  • Medical insurance
  • Vision insurance
  • Dental insurance
  • Life and disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right

Air Freight Pricing Leader

Responsible for developing and managing pricing strategies for freight services,...
Location
Location
Salary
Salary:
Not provided
aramex.com Logo
Aramex
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of experience in in air freight pricing or a similar role. Additional certifications in logistics or supply chain management are advantageous. Continuous professional development in pricing strategies and market analysis. Strong understanding of air freight operations and logistics. Experience in negotiating rates with carriers and airlines. Proficiency in data analysis and cost modeling. Familiarity with industry regulations and compliance standards. Ability to develop and implement pricing strategies. Experience with pricing software and tools. Ability to work collaboratively with sales and operations teams
Job Responsibility
Job Responsibility
  • Develop and implement freight pricing strategies
  • Set and maintain pricing policies to ensure competitiveness and profitability
  • Conduct regular pricing reviews and adjust strategies as needed
  • Manage the pricing budget and allocate resources effectively
  • Analyse market trends and competitor pricing
  • Conduct customer and market research
  • Conduct cost analysis to optimize pricing strategies
  • Identify opportunities for cost savings, efficiencies, and revenue growth
  • Monitor and analyse pricing performance metrics and key KPIs
  • Collaborate with freight manager, sales, operations, and intercompany teams to support business growth
Read More
Arrow Right

Pharmacy Intern

You’ve invested a lot of time and energy in your education. Now you want the cha...
Location
Location
United States , Philadelphia
Salary
Salary:
20.00 - 23.75 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
September 05, 2026
Flip Icon
Requirements
Requirements
  • Accepted into or actively enrolled in an ACPE accredited college or school of pharmacy
  • 0-3 years relevant work experience
  • Must possess or be in process of obtaining valid intern and/or technician licensure as required
  • Strong communication and presentation skills
  • Complete all required training within state guidelines and required timeframe
  • Ability to: Have regular and predictable attendance, including nights and weekends
  • Be mobile and remain upright for extended periods of time
  • Lift, scan, and bag items
  • Finger Dexterity: Picking, pinching, typing or otherwise working primarily with fingers rather than whole hand or arm
  • Reach overhead
Job Responsibility
Job Responsibility
  • Lead with Heart – display empathy and compassion for your patients, customers, caregivers, and colleagues on your team
  • Seek new ways to grow, collaborate with others, and deliver better outcomes
  • Align others around our purpose to bring your heart to every moment of your health and gain support and commitment
  • Facilitate a team culture that promotes caring, energy, enthusiasm, and pride
What we offer
What we offer
  • dental
  • vision
  • wellness resources
  • employee discounts
  • access to certain voluntary benefits
  • other programs
  • Parttime
Read More
Arrow Right

Special Educational Needs Teaching Assistant

Are you passionate about making a real difference in the lives of children with ...
Location
Location
United Kingdom , Henfield
Salary
Salary:
22022.00 - 23877.00 GBP / Year
https://www.randstad.com Logo
Randstad
Expiration Date
July 14, 2026
Flip Icon
Requirements
Requirements
  • Experience in SEN or SEMH settings
  • patient, creative, and resilient individual who can support SEN learners
  • believes in a holistic approach to education, focusing on both academic and emotional development
  • team player committed to fostering a positive, respectful learning environment
Job Responsibility
Job Responsibility
  • Support in the delivery of engaging and differentiated lessons tailored to individual pupil needs
  • work collaboratively with therapists and support staff to address each child's EHCP goals
  • foster confidence, respect, and independence in our pupils
  • use a variety of strategies, including sensory tools and movement breaks, to support learning
What we offer
What we offer
  • Supportive, child-centred environment where staff are valued and empowered
  • multi-disciplinary team including therapists, counsellors, and specialist support staff
  • focus on individuality - every child receives a personalised approach to learning
  • school culture that celebrates each child's strengths, whether in academics, sports, music, or the arts
  • ongoing professional development and training opportunities
  • welcoming, supportive team that shares a passion for transforming lives
  • Fulltime
Read More
Arrow Right