CrawlJobs Logo
Amgen Logo Amgen · IT - Administration

Sr Associate, Manufacturing (Technical Authoring/Deviation Investigations)

United States, New Albany Employment contract 86048.05 - 116417.95 USD / Year · Job Posted June 28, 2026
Apply Position
Job Link Share

Job Description

Let’s do this. Let’s change the world. In this role you will support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOP'S), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.

Job Responsibility

  • Support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOP'S), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process
  • Develop, review, and update technical content including but not limited to standard operating procedures, work instructions, risk assessments, protocols & reports for manufacturing team
  • Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data and tracking of technical documents
  • Liaise with manufacturing team and other cross functional departments regarding documentation changes in an effective and timely manner
  • Collaborate with multiple departments to support new/revise training documentation for manufacturing staff
  • Support process owners and participate in continuous process improvement and / or troubleshooting projects
  • Support manufacturing team in reducing document turnaround times
  • Ensure documentation related actions are completed on time and current schedule is maintained, accurate, and up to date
  • Develop protocols for Manufacturing to support change controls, deviations & troubleshooting investigations with provision from relevant SMEs
  • Generate, own, and provide subject matter expertise to Quality System records as minor deviations, CAPA, complaints, and change control records
  • Track pending activities required to support change control implementations
  • Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems
  • Share knowledge with members of the manufacturing team

Requirements

  • High school/GED + 4 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies
  • Associate’s + 2 years years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies
  • Bachelor’s + 6 months years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies
  • Master's

Nice to have

  • Educational Background in Science and/or Engineering
  • Experience working in GMP pharma and/or biotechnology industry
  • Experience in a Good Manufacturing Practices (GMP) environment and demonstrated background in technical writing
  • Experience with device assembly and packaging of final product
  • Ability to translate highly technical information into easily understandable information for manufacturing operators
  • Dynamic skills and usage of photographs, drawings, diagrams, animation, and charts that increase users’ understanding
  • Experience supporting deviations, investigations, CAPA’s and change controls
  • A fact-based problem solver with strong troubleshooting and problem-solving skills
  • Pro-active with the ability to prioritize work to meet benchmarks
  • Good documentation and communication

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
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

Sr Associate, Manufacturing (Technical Authoring/Deviation Investigations)

8 matching positions

New

Senior Clinical Research Associate

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activiti...
Location
Location
United States , Blue Bell
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in a relevant scientific discipline or healthcare-related field
  • Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements
  • Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
  • Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
  • Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
  • Willingness to travel as required (approximately 60%).
Job Responsibility
Job Responsibility
  • Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
  • Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
  • Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
  • Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
  • Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
What we offer
What we offer
  • Various annual leave entitlements
  • A range of health insurance offerings
  • Competitive retirement planning offerings
  • Global Employee Assistance Programme, LifeWorks
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments.
  • Fulltime
Read More
Arrow Right
New

Retail Optical Assistant

Retail Optical Assistant – Vision Express. Where customer service meets premium ...
Location
Location
United Kingdom , Llanelli
Salary
Salary:
Not provided
visionexpress.ie Logo
Vision Express
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Confident engaging with customers and recommending products
  • Passionate about eyewear, style, and comfortable with digital tools
  • Positive team player with a can-do attitude
  • Strong communicator who listens and understands customer needs
Job Responsibility
Job Responsibility
  • Deliver confident personalised customer service and product advice
  • Learn to adjust frames, assist with fittings, and carry out minor repairs
  • Support pre-screening eye tests using the latest optical technology
  • Keep the store running smoothly with admin and support tasks
What we offer
What we offer
  • £350 towards frames or designer sunglasses, with unlimited spend on lenses
  • 33 days holiday with buy/sell options
  • Family & friends discounts + free eye tests
  • Employee wellbeing support
  • Opportunities to support global vision through the OneSight Foundation
  • Monthly bonuses: Full-time Optical Assistants meeting targets can earn £85–£520/month bonus with uncapped potential for high performers
  • Parttime
Read More
Arrow Right
New

IT Strategy & Innovation Manager

As IT Strategy & Innovation Manager, you will define, lead, and continuously evo...
Location
Location
Monaco , Monaco
Salary
Salary:
Not provided
airswift.com Logo
Airswift Sweden
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 10+ years of experience in IT Strategy, Enterprise Architecture, Digital Strategy, or Strategic Planning roles
  • Proven track record defining and executing multi-year IT strategies and translating them into actionable roadmaps and measurable outcomes
  • Experience developing enterprise-level AI guidance, including vision, strategy, governance, and guardrails
  • Familiarity with product- and platform-oriented operating models
  • Experience managing strategic vendors and partners, including sourcing strategies and long-term planning
  • Ability to translate complex technology concepts into clear, actionable business recommendations
  • Strong executive communication and stakeholder management skills
  • Experience working across business, IT, security, risk, and finance functions in a complex organization
  • Demonstrated people leadership experience, including coaching and performance management
  • Fluent English (written and spoken) is required
Job Responsibility
Job Responsibility
  • Define, own, and continuously evolve the corporate IT Strategy and rolling 3-Year IT Plan, ensuring alignment with business objectives and priorities
  • Translate IT strategy into a clear executive-level narrative supported by KPIs, scorecards, and a structured governance and review framework
  • Define and maintain Corporate AI Guidance, including AI vision, strategy, governance principles, decision frameworks, and enterprise guardrails
  • Own and maintain the business capability map and associated heatmaps, linking platforms, solutions, and initiatives to value, risk, and organizational readiness
  • Establish and align the IT Innovation process with the broader corporate innovation framework, including intake criteria, prioritization, governance, and scaling mechanisms
  • Lead and foster the IT Innovation community, engaging business and IT stakeholders around shared priorities, experimentation, and continuous learning
  • Manage the Emerging Technology Radar and associated decision forums, ensuring insights influence architecture, platform decisions, and investment planning
  • Translate technology trends and performance insights into solution roadmaps and sourcing strategies, supporting a product- and platform-oriented operating model
  • Collaborate closely with Enterprise Architecture, Data, Security, Risk, and Delivery teams to ensure solutions are compliant, feasible, and value-driven
  • Prepare and present executive-level materials (strategy updates, technology radar, quarterly scorecards) and facilitate structured reviews with senior leadership and audit stakeholders
  • Fulltime
Read More
Arrow Right
New

Machinist / Tool Maker

We are currently seeking a skilled Machinist / Tool Maker to join our team. The ...
Location
Location
United Kingdom , Lasham
Salary
Salary:
44000.00 GBP / Year
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven experience as a machinist or tool maker, preferably in an aerospace or manufacturing environment
  • Proficiency in operating manual machining equipment, including lathes, mills, and grinders
  • Ability to interpret engineering drawings and specifications
  • Strong attention to detail and precision
  • Excellent problem-solving skills and mechanical aptitude
  • Ability to work independently and as part of a team
Job Responsibility
Job Responsibility
  • Operate manual machinery to manufacture precision components according to engineering drawings and specifications
  • Set up and adjust machine tools and equipment to achieve optimal performance and accuracy
  • Fabricate, modify, and repair tools, fixtures, and other equipment used in aircraft maintenance and repair
  • Perform quality control checks to ensure that manufactured parts meet established standards and tolerances
  • Collaborate with engineering and maintenance teams to identify and address manufacturing and tooling requirements
  • Maintain a clean and organized work area and comply with safety regulations and procedures
What we offer
What we offer
  • Competitive salary
  • Generous holiday allowance and company pension scheme
  • Opportunities for career development and training
  • Access to facilities and equipment
  • Dynamic and supportive work environment with opportunities for advancement
  • Fulltime
Read More
Arrow Right
New

Assistant General Manager

We’re on the lookout for Assistant General Managers to be part of our vibrant & ...
Location
Location
United Kingdom , Cambridge
Salary
Salary:
Not provided
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Have a genuine passion for hospitality and ensuring that the teams they lead and work in share this
  • Possess a huge personality and are not afraid to use it
  • A love for food, drink, customer service and, above all else, people
  • An entrepreneurial spirit with bags of business savvy and self-drive
  • Have previous experience as a Deputy or Assistant General Manager and a background in customer service-focused hospitality
Job Responsibility
Job Responsibility
  • Supporting the General Manager in the smooth running of the venue, doing everything you can to make sure our guests have the best possible experience whilst in our venue
  • Deputising for the General Manager as and when required
  • Delivering training to Team Members joining our Everyman family
  • Delegating with the rest of the management team responsibility for Team Member recruitment, social media marketing, film scheduling, stock taking amongst other important duties
What we offer
What we offer
  • A competitive package that reflects your experience and passion
  • Unlimited complimentary cinema tickets for you and your buddies
  • 50% Everyman discount on all food & drink (unfortunately no reduction on calories)
  • Wagestream membership - access to your wages when you need
  • 24/7/365 Employee Assistance Programme by Hospitality Action, the industry's charity
  • Financial, Legal, Family, Health and Wellbeing tools and resources
  • Retail discounts with Wagestream
  • Cycle to Work Scheme
  • Epic staff events, team socials, and amazing incentives
  • Above all else, a very good reason to get out of bed in the morning
  • Fulltime
Read More
Arrow Right
New

Driver (Fleet Specialist)

As a Driver (Fleet Specialist), you'll be out in Stockholm every day - driving o...
Location
Location
Sweden , Stockholm
Salary
Salary:
Not provided
voi.com Logo
Voi Technology
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A valid Swedish or EU driving licence (category B)
  • Good English, spoken and written
  • A solid knowledge of Stockholm and confidence driving in the city
  • Comfortable using a smartphone and basic apps
Job Responsibility
Job Responsibility
  • Collecting and deploying Voi vehicles across the city
  • Searching for and recovering damaged vehicles in the field
  • Swapping batteries and carrying out quick on-site repairs
  • Diagnosing faults and carrying out repairs at the warehouse
  • Disassembling and recycling vehicles beyond repair
  • Receiving, packaging and preparing new vehicles and batteries
  • Keeping the fleet tidy - spotting damaged vehicles, clearing up parking spots, lifting fallen vehicles
  • Parttime
Read More
Arrow Right
New

Support Worker

As a Female Support Worker in Blaenau Gwent, you’ll help make the everyday remar...
Location
Location
United Kingdom , Blaenau-Gwent
Salary
Salary:
13.59 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Patience and empathy
  • can support a person with their intimate personal care with respect and dignity
  • strong communication and teamwork skills
  • able to speak on behalf of others as well as to a range of professional people
  • good written skills and the ability to record events with empathy and meaning
  • full driving licence - essential
  • access to own car and happy to use this for transporting people we support
  • are female (this is a genuine occupational requirement due to the nature of the role)
Job Responsibility
Job Responsibility
  • Actively support individuals in making their own choices and set their own goals
  • empower people to follow through on choices, including taking part in structured activities
  • offer practical support to help them meet responsibilities like paying bills, maintaining their homes, being good neighbours, and staying connected with friends and family
  • enhance well-being and focus on small, meaningful moments
What we offer
What we offer
  • Training and development opportunities
  • 25 days annual leave rising to 30 days after 5 years’ service with the option to buy and sell leave
  • Health and Wellbeing programme - 24 hour access to our Employee Assistance Programme
  • Company pension
  • Benefits and discount platform
  • Blue Light discount card
  • Fulltime
Read More
Arrow Right
New

Accounts Assistant

Renault Retail Group is looking for an experienced, hands-on Accounts Assistant ...
Location
Location
United Kingdom , Birmingham
Salary
Salary:
30000.00 GBP / Year
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven experience in a busy Accounts Assistant / Ledger role
  • Comfortable working in high-volume, deadline-driven environments
  • Strong attention to detail without losing pace
  • Ability to prioritise and manage multiple tasks simultaneously
  • Confident communicator, able to chase, resolve, and follow through
  • Proactive mindset – you take ownership rather than waiting for direction
  • Good working knowledge of Excel (sorting, filtering, basic formulas)
Job Responsibility
Job Responsibility
  • Processing and allocating high volumes of daily receipts (cheques, PDQs, BACS)
  • Managing payment allocations end-to-end, resolving missing remittance details directly
  • Monitoring debtor balances and proactively identifying and addressing overdue items
  • Completing bank and nominal reconciliations, investigating and resolving discrepancies
  • Processing purchase invoices and credit notes using systems such as CDK / Kerridge / Keyloop Drive
  • Supporting month-end deadlines, ensuring all transaction data is accurate and complete
  • Liaising with internal stakeholders and the outsourced finance team in India to ensure smooth workflow and issue resolution
  • Maintaining accurate records and handling general administrative finance tasks
What we offer
What we offer
  • 33 days’ annual leave including Bank Holidays (with the option to buy or sell additional days)
  • Pension scheme which includes permanent health insurance and death-in-service benefit
  • A family new car scheme is available for close family members from £139 per car per month (1st car after probation, 2nd car after 12 months service). Car insurance is included on this scheme.
  • Enhanced Maternity and Paternity policies
  • Share Incentive Scheme
  • Staff discounts on new and used vehicles, parts, servicing, and accessories
  • Eye‑test voucher scheme
  • Cycle‑to‑Work scheme, including e‑bikes
  • Discounted gym membership
  • Enhanced Maternity and Paternity policies
  • Fulltime
Read More
Arrow Right