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

Finance Manager

Location
Location
Ireland , Cashel, Tipperary
Salary
Salary:
Not provided
waystone.com Logo
Waystone Governance Ltd.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Partly qualified accountant but working towards fully qualified (ACA/ACCA/CIMA)
  • University degree in accounting or business
  • A minimum of 2 years PQE in a similar Finance role
  • Experience managing people
  • Strong technical accounting skills including tax, financial reporting and financial statements
  • Previous use of accounts package such as Xero, Sage or SAP would be desirable
  • A high level of customer focus towards both internal and external customers
  • Very organised and have excellent attention to detail
  • Quick learner and work at speed in a fast-paced environment
  • It is essential to be trustworthy and understand the need for confidentiality
Job Responsibility
Job Responsibility
  • Plan, organise and complete tasks to ensure client engagement requirements are met including adherence to monthly and quarterly reporting deadlines
  • Managing staff and assisting team development along with your manager by providing guidance, training and mentoring, setting their goals and monitoring performance
  • Continuously seek to improve and develop methods and processes with the key to making the team more effective and efficient
  • Work within a team to ensure delivery of accurate monthly/quarterly/annual cash management, management and statutory financial information to clients and auditors
  • Provision of financial information to clients and customers
  • Corporation tax, VAT and Central Bank returns adhere to strict filing deadlines
  • Liaise with payroll department to run payroll and associated payroll reports for all clients and ensure tax returns adhere to strict filing deadlines
  • Perform and review regulatory reporting filing, tax reporting filing, quarterly and annual management accounts and year-end financial statements
  • Ensures all regulatory and compliance requirements are met for assigned portfolio of clients
  • Keep abreast with all financial reporting and regulatory changes
  • Fulltime
Read More
Arrow Right

Billing / Accounts Receivable Specialist

We are looking for a detail-oriented Billing / Accounts Receivable specialist to...
Location
Location
United States , Burr Ridge
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma required
  • Previous experience in accounts receivable, collections, billing, or a related accounting support function
  • Proficiency with Microsoft Excel and other Microsoft Office applications
  • Familiarity with accounting software and financial systems
  • SAP experience is a plus
  • Strong written and verbal communication skills with the ability to work effectively across departments and with customers
  • Solid organizational skills, attention to detail, and the ability to analyze account information accurately
  • Working knowledge of general math, cash activity, check processing, and core billing or receivables functions
  • Experience with construction accounting, lien waivers, AIA billing, and discrepancy resolution is preferred
Job Responsibility
Job Responsibility
  • Follow established accounts receivable workflows and maintain accurate processing standards across daily activities
  • Investigate account variances by gathering supporting documentation, reviewing records, and determining the source of discrepancies
  • Address unauthorized or incorrect deductions by applying defined resolution procedures and tracking outstanding items to closure
  • Communicate with customers regarding past-due balances and work toward timely payment through effective negotiation
  • Coordinate with teams such as order entry, finance, controllership, cash application, and billing to resolve account-related issues
  • Prepare and submit requests for cancellations, credits, and rebills when account corrections are needed
  • Manage dispute resolution activities and maintain clear documentation of actions taken on customer accounts
  • Complete billing-related documentation, including lien waiver and specialized customer billing submissions, in accordance with requirements
  • Safeguard sensitive financial information by handling records and communications with discretion and confidentiality
What we offer
What we offer
  • Medical
  • Vision
  • Dental
  • Life insurance
  • Disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right

Disbursements Specialist

We are looking for a detail-oriented Disbursements Specialist to join a team in ...
Location
Location
United States , Westchester
Salary
Salary:
22.00 - 26.50 USD / Hour
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 2–5 years of experience in disbursements, accounts payable, finance operations, or another high-volume transactional environment
  • Advanced proficiency in Microsoft Excel, including Pivot Tables, VLOOKUP, formulas, and large-scale data analysis
  • Strong analytical skills with the ability to interpret data, identify issues, and support informed decision-making
  • Experience preparing reconciliations, financial reports, or audit-related documentation
  • Ability to manage multiple priorities and consistently meet deadlines in a fast-paced setting
  • High level of accuracy, attention to detail, and commitment to process discipline
  • Effective written and verbal communication skills for working with cross-functional teams
Job Responsibility
Job Responsibility
  • Oversee daily payment and disbursement processing for a high volume of transactions while meeting accuracy and turnaround expectations
  • Examine financial activity for completeness and compliance, and investigate exceptions before final processing
  • Reconcile payment records, vendor-related items, and open balances to ensure accounts remain current and accurate
  • Prepare remittance details and other financial reports by consolidating information from multiple systems and data sources
  • Use advanced Excel tools, including Pivot Tables, VLOOKUP, formulas, and data analysis techniques, to audit large datasets and produce reporting insights
  • Partner with finance, accounting, and operations teams to resolve discrepancies, clear outstanding items, and support smooth workflow execution
  • Monitor aging items, unpaid transactions, and reconciliation variances, then communicate findings and recommended actions to leadership
  • Assist with audit support by gathering documentation, validating figures, and explaining transactional activity to stakeholders
  • Identify inefficiencies in existing processes and contribute to workflow improvements, testing efforts, and operational enhancements
  • Maintain organized records of procedures, controls, and updates to support consistency and compliance
What we offer
What we offer
  • medical
  • vision
  • dental
  • life and disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right

Insurance Defence Law & Motion Attorney

We are looking for an experienced Attorney/Lawyer to join a fast-moving litigati...
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
  • Juris Doctor from an accredited law school
  • Active California bar membership in good standing
  • Prior litigation experience, ideally within insurance defense, malpractice, toxic tort, environmental, or other complex civil matters
  • Working knowledge of civil procedure, discovery practice, and motion work
  • Demonstrated ability to analyze extensive records and extract relevant legal and factual points
  • Strong skill in preparing clear and accurate medical summaries and deposition summaries
  • Excellent legal writing, analytical thinking, and organizational abilities
  • Proven capacity to handle multiple cases and competing deadlines in a fast-paced environment
Job Responsibility
Job Responsibility
  • Manage litigation assignments across a range of civil matters, with an emphasis on insurance defense and malpractice-related claims
  • Contribute to complex disputes involving toxic exposure, environmental contamination, and cases connected to government entities
  • Prepare, serve, and answer written discovery while ensuring compliance with procedural deadlines and case strategy needs
  • Draft substantive legal documents such as pleadings, motions, briefs, and other court filings in support of ongoing litigation
  • Present and argue motion-related matters when needed, using well-developed legal analysis and persuasive advocacy
  • Review case files, records, and large document sets to identify key facts, risks, and evidentiary issues
  • Create organized medical chronologies and deposition summaries to support case evaluation and trial preparation
  • Partner with the broader legal team on factual development, defense strategy, and day-to-day case management across varied practice areas
What we offer
What we offer
  • medical, vision, dental, and life and disability insurance
  • enrollment in company 401(k) plan
  • Fulltime
Read More
Arrow Right

Labor & Employment Litigation Attorney

Robert Half Legal is partnering with a well-established boutique labor and emplo...
Location
Location
United States , Encino
Salary
Salary:
65.00 - 80.00 USD / Hour
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Active California Bar license and in good standing
  • Demonstrated employment law experience in California
  • Strong background in labor and employment litigation
  • Ability to work independently in a fully remote environment
  • Experience representing either plaintiffs or defendants is welcome
Job Responsibility
Job Responsibility
  • Draft dispositive motions
  • Prepare and respond to discovery
  • Draft pleadings, briefs, and other litigation documents
  • Conduct legal research and analysis
  • Assist with case strategy and overall litigation support
What we offer
What we offer
  • Medical, vision, dental, and life and disability insurance
  • eligibility to enroll in our company 401(k) plan
  • free online training
Read More
Arrow Right
New

Claims Support Officer

Working within the Clients division, you will provide vital, accurate, and effic...
Location
Location
Australia , Geelong
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
August 02, 2026
Flip Icon
Requirements
Requirements
  • Proven Administration Experience: Background working effectively within a fast-paced environment
  • Exceptional Prioritisation Skills: A demonstrated capacity to manage varied tasks, meet tight deadlines, and work autonomously
  • Strong Communication: The ability to communicate clearly and build strong relationships with stakeholders via phone, email, and internal channels
  • Tech Savvy: System literacy with intermediate knowledge of Microsoft Office programs (Word, Excel, PowerPoint) and ease navigating multiple databases
  • Critical Thinking & Adaptability: A knack for analyzing situations to form sound judgments, coupled with flexibility toward changing workflows
  • Secondary School/High School
Job Responsibility
Job Responsibility
  • Managing everyday administrative claims workflows efficiently and taking a proactive approach to all requests
  • Utilizing internal claims management databases and systems to accurately source and store information
  • Performing a range of administrative tasks, using your organizational skills to prioritize work based on urgency
  • Exercising sound judgment to identify and escalate risks that may impact task deadlines
  • Actively collaborating with team members to share knowledge and foster a supportive, inclusive team environment
Read More
Arrow Right

Account Manager – High-Plex Proteomics

Our client is an established market leader, launching an innovative platform for...
Location
Location
United States , Bay Area; Boston; Philly/NJ
Salary
Salary:
Not provided
achievebio.com Logo
AchieveBio
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS in life science discipline
  • advanced degree preferred
  • 5+ years technical sales experience in life sciences/drug discovery
  • proven track record of performance
  • experience selling workflows involving multi-omics
  • proteomics or spatial biology
  • knowledge of protein biology
  • biomarker discovery
  • and translational research workflows
  • strong hunting/prospecting/business development skills
Job Responsibility
Job Responsibility
  • Develop and execute business plan to successfully achieve territory sales quotas
  • Build and manage a qualified pipeline from the ground up
  • Establish relationships with KOLs and early adopters to build market momentum
  • Present technical product presentations and represent company at tradeshows
What we offer
What we offer
  • competitive salary
  • lucrative and uncapped commissions
  • car allowance
  • excellent benefits
  • Fulltime
Read More
Arrow Right