Senior Associate Quality Assurance / Aseptic Coach Job at Amgen (Thousand Oaks)

Senior Associate Manufacturing (Operations Lead)

The Sr. Associate Manufacturing – Strategic Projects role offers the opportunity...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

Sr. Manager Quality Control - Chemistry

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , Holly Springs

Salary:

142103.85 - 192258.15 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Aseptic Manufacturing experience OR Associate’s degree and 10 years of Aseptic Manufacturing experience OR Bachelor’s degree and 8 years of Aseptic Manufacturing experience OR Master’s degree and 6 years of Aseptic Manufacturing experience OR Doctorate degree and 2 years of Aseptic Manufacturing experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Job Responsibility

Lead teams responsible for the QC Chemistry laboratory and 1st and 2nd shift Quality Control operations
Include the startup and validation of laboratory equipment, transfer and implementation of analytical methods, and development of a diverse team to support site startup and successfully transition into steady-state commercial operations at Amgen North Carolina
Overall responsibility for startup, operational readiness, and day-to-day management of the QC Chemistry laboratory and oversight of 1st and 2nd shift QC teams, including successfully transitioning the organization from site startup activities into routine commercial operations
Lead QC Chemistry functions supporting analytical method families including chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel-based methods, and general compendial chemistry testing
Manage 1st and 2nd shift managers 7 days a week for cross functional night shift support for manufacturing
Ensure laboratory and shift operations are conducted in compliance with safety guidelines, cGLPs, cGMPs, and other applicable regulatory requirements
Build, lead, coach, and develop a high-performing organization capable of supporting both startup execution and long-term commercial manufacturing operations
Implement effective digital tools for leading the organization
Partner cross-functionally with Manufacturing, Process Development, Quality Assurance, Facilities & Engineering, Supply Chain, and other site functions to support startup readiness, process performance, and ongoing manufacturing operations
Participate in regulatory agency inspections and support site licensure and inspection readiness activities

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

Fulltime

Global Business Development Manager

SP Industries Inc., an ATS Company is seeking an experienced Global Business Dev...

Location

United States , Warminster

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

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

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

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

New

IT Training Lead

The IT Training Lead will drive technology learning and user adoption across the...

Location

United States , Delray Beach

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Experience in IT training, instructional design, technical enablement, or learning and development
Strong knowledge of Microsoft 365
Excellent communication, facilitation, and content development skills
Ability to translate technical concepts into practical, user-friendly training.

Job Responsibility

Design, develop, and deliver IT training programs in instructor-led, virtual, and self-paced formats
Take lead in the Microsoft Copilot and AI training strategy, including onboarding, advanced use cases, responsible AI usage, and ongoing enablement
Partner with IT leadership to support new technology rollouts, system upgrades, and digital transformation initiatives
Create and maintain training content, including videos, guides, tutorials, and job aids
Identify skill gaps and develop targeted learning solutions to improve adoption and productivity
Gather feedback and measure training effectiveness to continuously improve programs.

New

K Kitchen Representative

The position includes, but is not limited to, the following essential job duties...

Location

United States , New Albany

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Excellent communication skills
Team player who can work well with others or independently
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Frequently bend, twist at waist, kneel, squat, stand, and walk
Occasionally climb and descend ladders
Tolerate extreme cold and hot temperatures and work in and around fryers, ovens, grills, coolers, freezers, sharp objects, and loud noises
Reach, grasp, and manipulate objects with hands for entire shift, including reaching for objects overhead

Job Responsibility

Provides excellent guest service in a fast and friendly manner
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Prepares and serves food items in accordance with all Brand, Company, and health department regulations
Ensures product quality, food safety, and operational standards are met
Keeps accurate cash, sales, and inventory control records
Follows all government laws and safety codes
Completes reports on all incidents following our 5-minute rule policy
Lives our Company values: One Team, Do the Right Thing, Takes Ownership, Play to Win

What we offer

Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts (FT)
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program
Discount Meal Benefit
Wellness Plan

New

K Kitchen Representative

Location

United States , Decatur

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Excellent communication skills
Team player who can work well with others or independently
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Frequently bend, twist at waist, kneel, squat, stand, and walk
Occasionally climb and descend ladders
Tolerate extreme cold and hot temperatures and work in and around fryers, ovens, grills, coolers, freezers, sharp objects, and loud noises
Reach, grasp, and manipulate objects with hands for entire shift, including reaching for objects overhead

Job Responsibility

Provides excellent guest service in a fast and friendly manner
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Prepares and serves food items in accordance with all Brand, Company, and health department regulations
Ensures product quality, food safety, and operational standards are met
Keeps accurate cash, sales, and inventory control records
Follows all government laws and safety codes
Completes reports on all incidents following our 5-minute rule policy
Lives our Company values: One Team, Do the Right Thing, Takes Ownership, Play to Win

What we offer

Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts (FT)
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program
Discount Meal Benefit
Wellness Plan

New

Restaurant Assistant Manager

This position assists the Restaurant Manager (RM) with daily operations of the r...

Location

United States , Holly Springs

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Full time required
availability during all hours of operation and at least one hour pre-opening and post-closing required
Valid state Driver's License required
Excellent communication skills
Motivates, coaches, and leads team members
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Ability to gain control during stressful situations

Job Responsibility

Assists the Restaurant Manager with daily operations of the restaurant and supervises the team in their absence
Leads and coaches Restaurant Team Members and partners with the management team to maintain the Company and Brand operational standards
Provides excellent guest service in a fast and friendly manner
coaches and corrects team
Conducts second interviews for team members and shift leads
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Assigns shift duties to team members and follows up to ensure completion
Directs team and ensures all food items are prepared and served in accordance with all Brand, Company, and health department regulations
Coaches team members to follow guidelines for food preparation and production management
Cascades relevant information to team members and assists with new product training

What we offer

Unlimited tip pooling
Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts
Short-Term Disability
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program

Fulltime

New

Plant Operator - Crushing and Screen

Are you an experienced and ticketed Machine Operator looking for stable, high-ho...

Location

Australia , Petrie

Salary:

42.00 - 52.00 AUD / Hour

Randstad

Expiration Date

July 09, 2026

Requirements

Proven Experience working in a quarry, concrete recycling, or heavy industrial yard
Current tickets for Front-End Loader (LL) and Excavator (LE)
Truck License: Heavy Rigid (HR) or higher is highly regarded
Reliability with strong work ethic and punctuality
Own reliable vehicle and current driver's license

Job Responsibility

Safe and efficient operation of heavy machinery in a fast-paced recycling and quarry environment
Operating Front-End Loaders
Operating Excavators utilized as material handlers
Operating Moxy (Articulated Dump Trucks) and other yard machinery as required
Assisting with daily machinery pre-starts, basic maintenance, and ensuring the yard runs smoothly
Adhering strictly to site health and safety protocols

What we offer

Top Rates: $42.00 to $52.00 per hour + overtime penalties
Big Hours: Consistent 40 to 55-hour work weeks
Career Progression: Pathway from casual to permanent full-time employment within 3-6 months
Local Work: Convenient Brisbane Northside location (Petrie)
Immediate Start

Fulltime

Select Country

Senior Associate Quality Assurance / Aseptic Coach

Job Description

Job Responsibility

Requirements

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What we offer

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