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

Town Planner

The town of Londonderry, NH, is seeking an experienced professional to serve as ...
Location
Location
United States , Londonderry
Salary
Salary:
87000.00 - 126000.00 USD / Year
mma.org Logo
Massachusetts Municipal Association
Expiration Date
July 09, 2026
Flip Icon
Requirements
Requirements
  • Bachelor's degree in urban planning, geography, or a related field (master's preferred) and three to five years of professional municipal planning experience
  • Must possess thorough knowledge of master planning, zoning ordinances, and subdivision/site plan regulations
  • Excellent communication and customer service skills are required.
Job Responsibility
Job Responsibility
  • Serve as primary technical staff member handling day-to-day administration of planning, zoning, development review, and land use activities
  • Serve as primary staff liaison to the Planning Board and Zoning Board of Adjustment, providing vital technical reviews, zoning interpretations, and regulatory guidance.
  • Fulltime
Read More
Arrow Right

Care Assistant

At Highgate Care, kindness isn’t just something we talk about, it’s the foundati...
Location
Location
United Kingdom , Allerton Bywater
Salary
Salary:
12.77 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Warm, approachable, and brimming with positivity
  • Organised, reliable and a teamplayer
  • Creative, enthusiastic, and able to motivate others
  • Passionate about improving the lives of older people
  • Able to work flexibly across some evenings and weekends
  • Previous experience in a care setting is a bonus, but we’re just as interested in your personality and values
Job Responsibility
Job Responsibility
  • Ensure the highest possible levels of care are maintained by supporting/assisting Residents, when required, with washing, toileting, dressing, undressing, and all other aspects of daily living
  • Assist Residents in all aspects of their care needs (e.g. physical, emotional and spiritual). Provide attention when needed, whilst ensuring Residents retain their comfort and dignity
  • Pay particular attention to assisting Residents who have limited mobility, or physical / learning difficulties, making the best use of aids provided
  • Closely monitor Residents who may be confused and / or who have behavioural problems
  • Assist in the promotion of continence
  • Assist in the delivery of care for Residents who are passing away or who have a progressive illness. Assist with last offices
  • Observe care planning needs for Residents and complete written daily records as instructed and in line with the Company’s policies and procedures
  • Assist in framework of social activities by interacting with Residents and helping them continue with hobbies and activities in the Home
  • Answer Nurse call system, giving assistance as required. Answer the door and telephone appropriately. Respond accordingly, and pass on messages promptly
  • Under the supervision and guidance of senior Care Staff, report on the well-being of Residents
What we offer
What we offer
  • A friendly, supportive, and welcoming workplace
  • Real opportunities for ongoing training and career progression
  • A chance to make a meaningful impact in people’s lives every day
  • A valued role within a close-knit team that cares as much about each other as we do our residents
  • Fulltime
Read More
Arrow Right

Test Automation Engineer

SKIDATA is a global leader in access solutions for sports, entertainment, and mo...
Location
Location
India , Bangalore
Salary
Salary:
Not provided
parking.net Logo
Parking Network B.V.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Computer Science, Information Technology, or a related field
  • 4–5 years of experience in software testing, with at least 2 years in end-to-end test automation using Cypress or Playwright
  • Strong proficiency in JavaScript/TypeScript
  • Solid understanding of test design, test data management, and test reporting
  • Familiarity with API testing (REST and similar protocols)
  • Experience with agile methodologies and a passion for continuous improvement
  • Excellent analytical, communication, and collaboration skills
  • Good written and spoken English skills (B1 level or higher)
Job Responsibility
Job Responsibility
  • Design & Build Automation Frameworks: Architect and implement robust end-to-end test automation frameworks using Cypress and/or Playwright that ensure product quality at scale
  • Drive Test Strategy: Define test design, manage test data, and establish test reporting standards across agile delivery cycles
  • Champion Quality in Agile Teams: Collaborate closely with developers, product owners, and cross-functional teams to embed quality throughout the software development lifecycle
  • Expand Test Coverage: Apply your expertise in API testing (REST) and bring a security and performance testing mindset to continuously raise the quality bar
  • Explore & Innovate: Research and implement the latest QA tools, methodologies, and best practices—particularly in payment systems and e-commerce platforms
What we offer
What we offer
  • Health Insurance – Group Mediclaim (₹5L floater) covering employee, spouse & children
  • plus Group Personal Accident & Term Life Insurance (2× annual CTC each)
  • Wellness – Annual health check-up + ₹5,000/year reimbursement for gym, yoga & wellness memberships
  • Leave – 30 working days/year + 13 national holidays
  • Maternity (26 weeks), Paternity (5 days), Miscarriage & Marriage leave
  • Flexible Work – Hybrid model with up to 8 WFH days/month
  • Gift Vouchers – For birthdays, weddings & newborns
  • Meals & Snacks – ₹1,500/month via Pluxee Cards
  • Daycare Support – Crèche/daycare reimbursement for women employees (up to 2 children)
  • Financial Benefits – NPS contributions, Gratuity, short-term loans via HDFC Bank
  • Fulltime
Read More
Arrow Right

Payroll, Accounts Payable, and Benefits Coordinator

The Payroll, Accounts Payable, and Benefits Coordinator processes employee payro...
Location
Location
United States , Norton
Salary
Salary:
25.62 - 32.13 USD / Hour
mma.org Logo
Massachusetts Municipal Association
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in payroll processing
  • accounts payable
  • benefits administration
  • knowledge of tax regulations and accounting procedures
  • proficiency with payroll software
  • attention to detail
  • confidentiality
  • ability to coordinate with HR
Job Responsibility
Job Responsibility
  • Process bi-weekly payroll for all town employees
  • maintain employee payroll records and prepare payroll-related reporting
  • coordinate with Human Resources regarding new hires, terminations, and compensation changes
  • review, verify, and process vendor invoices
  • process employee benefit enrollments, changes, terminations
  • update records with retirement systems
  • Fulltime
Read More
Arrow Right

Director of Assessment

Full-Time (34 hours/week) | Exempt | Grade N-7 Salary Range: $83,926 – $117,501 ...
Location
Location
United States , Boxford
Salary
Salary:
83926.00 - 117501.00 USD / Year
mma.org Logo
Massachusetts Municipal Association
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in business, public administration, finance, real estate, or a related field
  • Five years of progressively responsible municipal assessing experience, including property valuation and tax administration responsibilities
  • Massachusetts Accredited Assessor certification preferred, or ability to obtain certification
  • Knowledge of Massachusetts assessment laws, regulations, and valuation practices
  • Strong communication, organizational, and customer service skills
  • Experience with computerized assessing systems and municipal software applications
Job Responsibility
Job Responsibility
  • Administer all municipal assessing functions in accordance with Massachusetts law and Department of Revenue regulations
  • Support the Board of Assessors by preparing agendas, attending meetings, implementing board policies, and managing the day-to-day operations of the Assessing department
  • Oversee property valuation, certification, and revaluation activities
  • Conduct property inspections and field reviews to maintain accurate assessment records
  • Manage exemptions, abatements, Chapter Land programs, and personal property filings
  • Prepare required reports and submissions to the Department of Revenue
  • Maintain assessment records, tax maps, and property data
  • Supervise assessing staff and coordinate contracted appraisal services
  • Represent the Town before the Appellate Tax Board and other agencies as needed
  • Provide responsive service and technical assistance to residents, businesses, and Town departments
  • Fulltime
Read More
Arrow Right

Department Assistant I – Select Board/Town Manager’s Office

The town of Sudbury is currently accepting applications for the position of Depa...
Location
Location
United States , Sudbury
Salary
Salary:
23.98 - 31.53 USD / Hour
mma.org Logo
Massachusetts Municipal Association
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School diploma and two years of experience in administrative support or related field
  • any equivalent combination of education and experience will be considered
  • Proficiency with MS Office, particularly Word and Excel
Job Responsibility
Job Responsibility
  • Answering phone calls
  • greeting and assisting visitors
  • receiving and sorting mail
  • scheduling meetings and appointments
  • preparing a variety of documents and correspondence
  • processing invoices and departmental payroll
  • assisting with large projects such as Town Meeting and special events
What we offer
What we offer
  • Pre-determined step system for annual pay increases
  • excellent benefits
Read More
Arrow Right

Cash Applications Lead

We are seeking an experienced Cash Applications Lead to join a growing finance t...
Location
Location
United States , Long Beach
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 6+ years of experience in cash applications, accounts receivable, treasury operations, or related accounting functions
  • Experience working within an ERP environment
  • Strong understanding of cash management, reconciliations, and general accounting principles
  • Advanced Excel skills, including data analysis and reporting
  • Excellent problem-solving and analytical abilities
  • Strong organizational skills with the ability to manage multiple priorities
  • Effective communication skills and the ability to collaborate across departments
  • Experience in a multi-entity or high-volume transaction environment is highly preferred
Job Responsibility
Job Responsibility
  • Process and reconcile daily cash transactions, including customer payments, electronic transfers, wires, lockbox deposits, and other banking activity
  • Ensure all cash receipts and disbursements are accurately recorded within the organization's ERP system
  • Investigate and resolve payment discrepancies, unapplied cash, and transaction exceptions
  • Monitor banking activity and maintain accurate records of cash movements
  • Perform account reconciliations and research variances
  • Support general ledger balancing activities and ensure transactions are recorded accurately
  • Assist with intercompany transactions and account clearing processes
  • Maintain strong internal controls and compliance with company policies and procedures
  • Assist with month-end and year-end close activities
  • Prepare reconciliations, supporting schedules, and documentation for financial reporting
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