Associate Quality Assurance (PQA) Job at Amgen (Tuas)

Sr Associate Quality Assurance

In this vital role you will be the Sr. Associate Plant Quality Assurance (PQA) o...

Location

United States , Holly Springs

Salary:

86928.00 - 106536.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience
Associate’s + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience
Bachelor’s + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience
Master's
Strong cGMP and GDP behaviors
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
Demonstrated experience with deviations records

Job Responsibility

Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems
Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements
Drive closure/completion of cGMP processes, procedures, documents and records
Ensure production and testing records/results are complete, accurate, and documented according to procedures
Oversee and provide guidance during on-the-floor analytical testing
Ensure that changes that could potentially impact product quality are assessed according to procedures
Ensure that deviations from established procedures are investigated and documented per procedures
Alert senior management of quality, compliance, supply and safety risks
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation

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
Stock-based long-term incentives
Award-winning time-off plans

Fulltime

Quality Assurance Specialist - Manufacturing Support

Serve as Quality Assurance Specialist responsible for Plant Quality Assurance (P...

Location

United States of America , Holly Springs

Salary:

104287.35 - 141094.65 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Associate’s degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Bachelor’s degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Master’s degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Doctorate degree

Job Responsibility

Provide Quality oversight to ensure that Operations’ products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
Perform review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA)
Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports
Oversee and provide guidance during on-the-floor analytical testing
Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
Ensure that changes that could potentially impact product quality are assessed according to procedures
Ensure that deviations from established procedures are investigated and documented per procedures
Alert senior management of quality, compliance, supply and safety risks
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation

Fulltime

Sr Associate QA I

Sr Associate QA I at Amgen in Holly Springs, North Carolina. This is an on-site ...

Location

United States , Holly Springs

Salary:

82081.95 - 111052.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Associate's + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Bachelor's + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience OR Master's

Job Responsibility

Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems
Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations
Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
Oversee and provide guidance during on-the-floor analytical testing
Ensure that changes that could potentially impact product quality are assessed according to procedures
Ensure that deviations from established procedures are investigated and documented per procedures
Alert senior management of quality, compliance, supply and safety risks
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation

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

Manager PQA

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , New Albany

Salary:

118235.00 - 159965.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master’s degree and 3 years of quality experience
OR Bachelor’s degree and 5 years of quality experience
OR Associate’s degree and 10 years quality experience
OR High school diploma / GED and 12 years of quality experience
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead, coach, and develop Quality staff across assigned areas and shifts
Provide QA oversight of manufacturing packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements
Ensure that facilities, equipment, processes, materials, and products meet all applicable quality and compliance standards
Review, approve, and oversee key quality systems including: Deviations
CAPAs
Change Controls
Validation documentation
Procedures and batch records
Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
Ensure production records and test results are accurate, complete, and inspection-ready

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

Fulltime

Specialist PQA

Amgen is expanding and with that comes an exciting opportunity to help build and...

Location

United States , New Albany

Salary:

104287.35 - 141094.65 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master’s degree and 2 years of Quality experience
OR Bachelor’s degree and 4 years of Quality experience
OR Associate’s degree and 8 years Quality experience
OR High school diploma / GED and 10 years Quality experience
Bachelor’s degree in Life Sciences, Engineering, or related field
3+ years of experience in Quality Assurance within a GMP-regulated environment
Strong experience in Quality Systems (deviations, CAPA, change control, disposition)
Experience supporting C&Q, validation, or startup activities highly preferred
Experience with New Product Introduction (NPI) in a regulated environment is a strong plus

Job Responsibility

Provide QA support for Commissioning & Qualification (C&Q) activities, including review/approval of protocols and reports
Actively support New Product Introduction (NPI) to ensure quality requirements are embedded from early stages through commercialization
Lead and support Quality Systems processes, including: Deviations
Product Disposition
CAPAs
Change Controls
Ensure timely, thorough, and compliant investigations, driving effective root cause analysis and sustainable solutions
Support batch disposition activities in alignment with packaging operations and quality requirements
Partner with cross-functional teams to ensure quality systems are effectively implemented during B2 startup and ramp-up
Drive and contribute to Continuous Improvement (CI) initiatives to enhance quality system performance and efficiency

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

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

Select Country

Associate Quality Assurance (PQA)

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?