Quality Auditor - Pharmaceutical Job at SQA Services (Milwaukee)

Senior Director Quality Assurance

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

Location

United States , West Greenwich

Salary:

218358.00 - 252850.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
Master’s degree and 8 years of Quality/Manufacturing/Engineering experience
Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience
At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead Plant QA team providing Quality Oversight of 24/7 continuous manufacturing operation and high impact strategic decision making in two (2) multi-product Drug Substance facilities
Scope includes on-the-floor support for AR5 Fed batch and AR30 MoF, I-530, Buffer Preparation Area, Media Preparation, Component Preparation Area, In Process Testing Lab, record review, quality oversight of deviation investigations and changes, document approval, and disposition
Ensure drug substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and other applicable regulations and specifications
Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
Provide quality input and partner with cross-site and cross-functional area leads to advance Amgen’s manufacturing strategy
Develop strategies in support of regulatory inspections and site audits
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties
Develop area budget, manage expenditure and identify productivity improvement opportunities
Represent ARI Quality in cross-function and cross-site forums

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 Auditor - Pharmaceutical

This is a contract opportunity in which you will perform supplier quality audits...

Location

United States , Milwaukee, WI / Algoma, WI / Janesville, WI / Madison, WI / Neenah, WI / Shawano, WI

Salary:

Not provided

SQA Services

Expiration Date

Until further notice

Requirements

5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries
Has been the lead auditor in at least 10 audits
Direct audit experience to 21 CFR part 210/211 and ISO 9001
Strong communication and writing skills
Proven ability to deescalate workplace conflicts effectively
Ability to adapt to new technology and software
Willingness to travel regionally

Job Responsibility

Perform supplier audits at various sites within your region of residence
Assure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries
Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule
Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc
Respond to the Content team in a timely manner regarding edits/questions to your audit report
Write audit reports in accordance with client specifications

What we offer

Flexibility to accept or reject assignments according to your own availability
Travel expenses are reimbursed at cost with receipts per SQA travel policy

Global Supplier Quality Senior Specialist

The Senior Specialist, Global Supplier Quality is responsible for driving suppli...

Location

Italy , Pomezia; Milano; Bologna; Alanno

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 7 years’ experience in supplier quality management within pharmaceuticals, medical devices, or food supplements
Strong working knowledge of GMP, ISO 13485, HACCP, and global regulatory expectations
Demonstrated success in supplier audits, risk-based quality management, and compliance oversight
Lead Auditor certification highly desirable
Bachelor’s or Master’s degree in Pharmacy, Chemistry, Engineering, or a related technical field
Proven experience using digital tools and systems for supplier qualification and performance management
Exceptional communication, stakeholder management, and problem-solving skills
Ability to operate effectively in a fast-paced, matrixed, and multicultural environment
Fluency in English required
Strong proficiency with Microsoft Office Suite and other business platforms

Job Responsibility

Lead global supplier qualification, approval, and requalification processes in alignment with corporate and regulatory standards
Develop and maintain comprehensive supplier risk assessments and qualification documentation
Oversee the full supplier lifecycle — from onboarding and performance monitoring to periodic reviews and requalification
Plan, conduct, and report supplier audits (both on-site and remote) to verify compliance with internal and external standards
Ensure adherence to GMP, ISO 13485, HACCP, and other applicable global quality and regulatory frameworks
Partner with suppliers to address audit findings, implement corrective and preventive actions, and monitor their effectiveness
Support site quality operations in reviewing and approving supplier-provided documentation, including change controls, technical files, and periodic reviews
Maintain and update Supplier Quality Agreements, ensuring alignment with internal policies and regulatory requirements
Contribute to the preparation and successful execution of regulatory inspections and customer audits related to supplier management
Proactively identify and mitigate supplier-related risks impacting product quality or supply continuity

Auditor, Quality

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

Location

United States of America , Guayama

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in science or related field with three (3) to five (5) years' experience
Fully Bilingual - written and spoken English and Spanish
Strong cGMP knowledge, 21 CFR Part 11, 210 and 211, ICH Q7A, Eudralex and other applicable to API and FG anesthetics
Professional License or Certification Required: Lead Auditor Certification

Job Responsibility

Leads internal audit program and readiness for the external inspections
Conduct assessments adhering to the approved internal audit schedule using the applicable Baxter Quality Manual, division and/or local procedures, applicable regulations, standards, inspection guidelines and compendial requirements
Lead the planning and development of assessment strategy and logistics for Internal and External Audits
Coordination and execution of the yearly audit schedule
Conduct audits/assessments by researching background information, including previous internal/external audit results, applicable regulations and standards as well as local and global standard operating procedures
Collect and analyze objective evidence regarding issues and risk
report findings (verbally and written) to management
Audit System Management Review presentation
Evaluate observations responses and CAPA action plan for adequacy, including risk impact, root cause, timeliness and effectiveness
Maintain audit file through the process up to audit closure

What we offer

Medical, Dental, Disability and Life Insurance coverage
Vision Plan
Paid Vacation Days and Paid Holidays
Paid Parental Leave
Retirement Plan 165e
Employee Stock Purchase Program
Educational Assistance Plan
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits

Fulltime

Quality Compliance - Senior Manager

Join Amgen’s Mission of Serving Patients. In this vital role you will be respons...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
12 to 15 years in Pharmaceutical and/or Biotechnology in Quality and/or Manufacturing experience
Lead Auditor Certification
Audit Experience in Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API)
Strong communication skills both verbal and written
Domestic and International travel up to 50%

Job Responsibility

Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers
Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies
Implements risk assessments
Ensure completion, maintenance and sustainability of the assigned training per specific roles to support the audit process
Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings
Serves as subject matter expert on global regulated requirements and inspectional commitments
Provides support for domestic and international Regulatory Authority Inspections when necessary
Provides technical support/compliance review of multi-site/global documents resolving compliance issues
Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations
Alerts senior and/or executive management of significant quality, and compliance risks

What we offer

competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Quality Assurance Release Supervisor

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

Location

Belgium , Lessines

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree in Science or Engineering
an advanced degree is preferred
Proven experience in a similar QA Release or QA leadership role
Demonstrated experience in people management
Experience with GMP requirements (EU GMP, EudraLex Volume 4) and medical device regulations
Strong knowledge of quality systems, compliance expectations and release processes
QP delegate experience/training is an asset
Strong analytical mindset and structured problem‑solving approach
Excellent communication, presentation and stakeholder‑management skills
Ability to work under pressure and adapt to change

Job Responsibility

Lead, supervise, coach and support a QA Release team of ~10 employees
Plan, coordinate and monitor batch file review activities
Ensure engagement, development and well‑being within the team
Manage and control finished product release for sterile drugs and medical devices
Review and approve deviations/events linked to the manufacturing process
Monitor and continuously improve release performance and associated KPIs
Prepare and present KPI results to site leadership, regional and global Quality teams
Serve as the QA Release representative for interactions with Manufacturing, Supply Chain, CMOs/3rd parties, Product Development, Corporate QA
Ensure efficient and compliant communication across departments
Ensure updates of quality documentation, SOPs and quality agreements

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 Assurance Release Supervisor

As a QA Release Supervisor, you lead and develop a team responsible for the rele...

Location

Belgium , Lessines

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree in Science or Engineering
an advanced degree is preferred
Proven experience in a similar QA Release or QA leadership role
Demonstrated experience in people management
Experience with GMP requirements (EU GMP, EudraLex Volume 4) and medical device regulations
Strong knowledge of quality systems, compliance expectations and release processes
QP delegate experience/training is an asset
Strong analytical mindset and structured problem‑solving approach
Excellent communication, presentation and stakeholder‑management skills
Ability to work under pressure and adapt to change

Job Responsibility

Lead, supervise, coach and support a QA Release team of ~10 employees
Plan, coordinate and monitor batch file review activities
Ensure engagement, development and well‑being within the team
Manage and control finished product release for sterile drugs and medical devices
Review and approve deviations/events linked to the manufacturing process
Monitor and continuously improve release performance and associated KPIs
Prepare and present KPI results to site leadership, regional and global Quality teams
Serve as the QA Release representative for interactions with Manufacturing, Supply Chain, CMOs/3rd parties, Product Development, Corporate QA
Ensure efficient and compliant communication across departments
Ensure updates of quality documentation, SOPs and quality agreements

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

Quality Assurance Release Supervisor

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

Location

Belgium , Lessines

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree in Science or Engineering
an advanced degree is preferred
Proven experience in a similar QA Release or QA leadership role
Demonstrated experience in people management
Experience with GMP requirements (EU GMP, EudraLex Volume 4) and medical device regulations
Strong knowledge of quality systems, compliance expectations and release processes
QP delegate experience/training is an asset
Strong analytical mindset and structured problem‑solving approach
Excellent communication, presentation and stakeholder‑management skills
Ability to work under pressure and adapt to change

Job Responsibility

Lead, supervise, coach and support a QA Release team of ~10 employees
Plan, coordinate and monitor batch file review activities
Ensure engagement, development and well‑being within the team
Manage and control finished product release for sterile drugs and medical devices
Review and approve deviations/events linked to the manufacturing process
Monitor and continuously improve release performance and associated KPIs
Prepare and present KPI results to site leadership, regional and global Quality teams
Serve as the QA Release representative for interactions with Manufacturing, Supply Chain, CMOs/3rd parties, Product Development, Corporate QA
Ensure efficient and compliant communication across departments
Ensure updates of quality documentation, SOPs and quality agreements

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

Quality Auditor - Pharmaceutical

SQA Services

Location:
United States , Milwaukee ▼
Algoma
Janesville
Madison
Neenah
Shawano

Category:
Pharmacy

Contract Type:
Contract work

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 18, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Quality Auditor - Pharmaceutical

Senior Director Quality Assurance

Quality Auditor - Pharmaceutical

Global Supplier Quality Senior Specialist

Auditor, Quality

Quality Compliance - Senior Manager

Quality Assurance Release Supervisor

Quality Assurance Release Supervisor

Quality Assurance Release Supervisor

Quality Auditor - Pharmaceutical

SQA Services

Location:United States , Milwaukee ▼AlgomaJanesvilleMadisonNeenahShawano

Category:Pharmacy

Contract Type:Contract work

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:February 18, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Quality Auditor - Pharmaceutical

Senior Director Quality Assurance

Quality Auditor - Pharmaceutical

Global Supplier Quality Senior Specialist

Auditor, Quality

Quality Compliance - Senior Manager

Quality Assurance Release Supervisor

Quality Assurance Release Supervisor

Quality Assurance Release Supervisor

Location:
United States , Milwaukee ▼
Algoma
Janesville
Madison
Neenah
Shawano

Category:
Pharmacy

Contract Type:
Contract work

Job Posted:
February 18, 2026