Specialist Quality Assurance - Drug Product Job at Amgen (Thousand Oaks)

Drug Product Quality Assurance Specialist

In this vital role within the Plant Quality Assurance organization the Drug Prod...

Location

United States , Thousand Oaks

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 of quality experience OR High school diploma / GED and 10 years of quality experience

Job Responsibility

Partners with Manufacturing, Facilities & Engineering, Quality Control, and other cross-functional stakeholders to facilitate root cause analyses, risk assessments, CAPAs, and effectiveness verification activities
Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations
Partners with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards
Provides Quality Oversight of the manufacturing facility including manufacturing operations, inspection and utilities, as well as nonroutine activities such as process and product validation
Provides quality expertise and guidance to operational staff and within cross functional Amgen teams
Reviews and approves controlled documents, including but not limited to Standard Operating Procedures, Protocols and Reports
Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Participates in Amgen internal/external audits and inspections
Directly interacts with regulatory agencies during on-site inspections
Contributes to and drives continuous improvement projects in cross-functional collaboration

What we offer

Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans

Fulltime

Specialist Quality Assurance – Drug Product Minor Deviations

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

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master's degree and 2 years of Quality Assurance experience
Bachelor's degree and 4 years of Quality Assurance experience
Associate's degree and 8 years of Quality Assurance experience
High school diploma / GED and 10 years of Quality Assurance experience

Job Responsibility

Serve as Quality investigation lead and decision-maker for complex deviations, maintaining accountability for designation, documentation quality, timeliness and closure
Actively participate in deviation meetings, managing multiple concurrent deviations and driving effective resolution
Provide Quality oversight to ensure thorough documentation of deviations, including floor presence, process observation, and personnel interviews across shifts, including nights when required
Review, approve, and track cGMP documentation, including Deviations, procedure updates and associated records
Demonstrate strong critical thinking skills, the ability to distinguish between a minor and mayor designation using evidence-based decision making
Ensure that deviations with potential impact to product quality are properly assessed and documented per established procedures
Verify that deviations from established procedures are investigated, documented, and resolved in accordance with Quality System requirements
Ensure production records, laboratory results, and investigation documentation to be used as evidence for deviations are complete, accurate, and compliant with cGMP standards
Collaborate cross‑functionally with Manufacturing, Engineering, Validation, and Quality to ensure information required for designation and/or closure of deviations is complete and accurate
Escalate and communicate quality, compliance, supply, and patient safety risks to senior management as appropriate

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
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

Specialist Quality Assurance – Drug Substance Deviations

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

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master's degree and 2 years of Quality Assurance experience
OR Bachelor's degree and 4 years of Quality Assurance experience
OR Associate's degree and 8 years of Quality Assurance experience
OR High school diploma / GED and 10 years of Quality Assurance experience

Job Responsibility

Provide Quality oversight to ensure clinical and commercial pharmaceutical products are manufactured, tested, stored, and distributed in compliance with cGMP and applicable regulations
Provides an additional QA oversight by critically reviewing and challenging deviation designations made at the shop floor to ensure accurate, consistent, and compliant classification
Collaborates with Manufacturing and cross-functional stakeholders to reassess impact, drive alignment, and support sound decision-making
Provides QA oversight by critically reviewing and challenging initial deviation write-ups to ensure accurate reflection of the event
Partners with deviation owners to strengthen event descriptions and ensure a clear, compliant initial resolution
Ensures that required sections, including further processing and continued operations, are completed accurately and within established timelines
Serve as Deviation QA Contact and decision-maker for deviations, maintaining accountability for investigation quality, timelines, documentation, and closure
Actively participate in deviation and RCA meetings, managing multiple concurrent deviations and driving effective resolution
Conduct thorough root cause investigations, including floor presence, process observation, and personnel interviews across shifts, including nights when required
Review, approve, and track cGMP documentation, including Deviations, CAPAs, CAPA Effectiveness Verification (EV), Change Controls, validations, and associated records

What we offer

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions
group medical, dental & vision coverage
life & disability insurance
discretionary annual bonus program
stock-based long-term incentives
award-winning time-off plans

Fulltime

Sr. Specialist I, Product Quality Assurance

The Sr. Specialist I, NC Product Quality Assurance (PQA) will be responsible for...

Location

United States , Durham

Salary:

140000.00 - 185000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in a scientific discipline with 10+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
Knowledge of aseptic processing, and/or cell and gene therapy is preferred
Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
Knowledge of global regulations and standards
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually as well as within a multi-disciplinary team
Excellent listening, communication and interpersonal skills with a team focus
Consistent delivery of high-quality work
Ability to gown and work in a cleanroom environment

Job Responsibility

Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
Provide Quality oversight of QC testing
Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
Real time review of batch records and labels
Review and approval of manufacturing discrepancies and associated CAPA's
Communicating lot disposition pending issues to management
Aid in the development and ongoing improvement of applicable quality systems for the site
identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
Review and approve calibration and maintenance work orders and asset inductions

Fulltime

Specialist II, Product Quality Assurance

The Specialist, NC Product Quality Assurance (PQA) will be responsible for suppo...

Location

United States , Durham, NC

Salary:

105000.00 - 145000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in a scientific discipline
10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
Knowledge of aseptic processing, and/or cell and gene therapy is preferred
Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
Knowledge of global regulations and standards
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually as well as within a multi-disciplinary team
Excellent listening, communication and interpersonal skills with a team focus
Consistent delivery of high-quality work

Job Responsibility

Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
Provide Quality oversight of QC testing
Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
Real time review of batch records and labels
Review and approval of manufacturing discrepancies and associated CAPA’s
Communicating lot disposition pending issues to management
Aid in the development and ongoing improvement of applicable quality systems for the site
identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
Review and approve calibration and maintenance work orders and asset inductions

Fulltime

Senior Specialist, Quality Assurance

Location

Japan , Minato, Tokyo

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Minimum 5 years of pharmaceutical quality experience and CMO management
Knowledge of PMD Act, GQP/GMP/QMS ordinances, and related regulations
Experience managing CMOs
Experience handling authority and overseas audits
Experience managing inspections from application to completion
Knowledge of pharmaceuticals and medical devices
Willingness to take on new challenges
Positive mindset and teamwork
Analytical and negotiation skills
English proficiency

Job Responsibility

Management and operation of GQP and GMP-related activities
Management and operation of QMS
Handling GMP/QMS compliance inspections
Quality assurance of pharmaceuticals and medical devices
Self-inspections, internal audits, and external audits
Manage, operate, and maintain GQP
GMP oversight for domestic and overseas manufacturers
Manage contract manufacturing organizations (CMOs)
Manage, operate, and maintain QMS
Application, coordination, and execution of inspections

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Senior Specialist, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Japan , Minato, Tokyo

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Minimum 5 years of pharmaceutical quality experience and CMO management
Knowledge of PMD Act, GQP/GMP/QMS ordinances, and related regulations
Experience managing CMOs
Experience handling authority and overseas audits
Experience managing inspections from application to completion
Knowledge of pharmaceuticals and medical devices
Willingness to take on new challenges
Positive mindset and teamwork
Analytical and negotiation skills
English proficiency

Job Responsibility

Management and operation of GQP and GMP-related activities
Management and operation of QMS
Handling GMP/QMS compliance inspections
Quality assurance of pharmaceuticals and medical devices
Self-inspections, internal audits, and external audits
Manage, operate, and maintain GQP
GMP oversight for domestic and overseas manufacturers
Manage contract manufacturing organizations (CMOs)
Manage, operate, and maintain QMS
Application, coordination, and execution of inspections

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Quality Specialist, Product Release

The Quality Specialist (12-month assignment) is responsible for supporting the m...

Location

Canada , Mississauga

Salary:

72080.00 - 108120.00 CAD / Year

Baxter

Expiration Date

Until further notice

Requirements

University Degree or equivalent experience and/or relevant post-secondary education and experience
Drug and/or medical device product release/product disposition experience
Excellent knowledge of GMPs and Health Canada regulations
Strong communication and technical writing skills
Ability to take initiative and multitask across projects
Experience with third-party logistics and quality frameworks such as NCR/CAPA, Change Control, and Documentation
Skills in MS Office and Windows operating systems

Job Responsibility

Review laboratory, transportation, and warehouse documentation to ensure product release
Disposition of both imported and domestic products
Work together with 3PL and internal teams on matters and steps related to product distribution in Canada
Manage and maintain all quality documents
Conduct impact assessments and complete tasks for change controls
Review and approve compliance documentation such as APQR, batch records, and stability data
Support method transfers and the launch of new products as required
Assist with product holds and quality assessments of returned products
Participate in internal audits and regulatory inspections to ensure compliance

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

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Specialist Quality Assurance - Drug Product

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