Quality Auditor - Pharmaceutical Job at SQA Services (Milwaukee, WI / Algoma, WI / Janesville, WI / Madison, WI / Neenah, WI / Shawano, WI)

Quality Auditor - Pharmaceutical

This is a contract role performing 1-2 day audits at various suppliers in the Mi...

Location

United States , Milwaukee; Algoma; Janesville; Madison; Neenah; Shawano

Salary:

Not provided

SQA Services

Expiration Date

Until further notice

Requirements

Direct experience auditing to 21 CFR part 210/211
Direct experience auditing to ISO 13485

Job Responsibility

Performing 1-2 day audits at various suppliers in the Midwest

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

Supplier Quality Engineer

The Supplier Quality Engineer leads the efforts in driving efficiency and in the...

Location

Canada , Coquitlam

Salary:

75500.00 - 90000.00 CAD / Year

Natural Factors

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline (i.e.: Chemistry, Engineering, Biology, or Food Science)
Experience in a similar role in food, natural health products (NHP), and/or pharmaceutical industry (5+ years)
Experience with performing or participating in supplier audits. Certified Quality Auditor/ Supplier Quality Auditor/Supplier Quality Engineer certification (an asset)
Knowledge of Canadian Food Inspection Agency (CFIA), Food and Drugs Act (FDA), Health Canada, and Australia’s (Therapeutic Goods Administration) TGA regulations
Knowledge of cGMP, GFSI, HACCP or equivalent
Proven project management skills
managing high volume suppliers and ingredients
Strong interpersonal skills with the ability to work with individuals with diverse backgrounds and skillsets
Competent with MS Office (i.e.: Word, PowerPoint & Excel)
including data collection, analysis, and reporting

Job Responsibility

Lead supplier and material qualification efforts within the eQMS through prompt evaluation, cross-functional collaboration, approval, and ensuring completion of post-approval actions
Manage requalification requests and determine appropriate steps, such as but not limited to requalification of supplier, material, change management, etc.
Monitor supplier performance and actively provide Procurement quality data critical to maintain the supplier scorecard
Conduct and coordinate supplier audits as part of routine audit program or triggered by supplier performance concerns
Manage Supplier Corrective Action Request (SCAR) program by initiating the workflow with the vendor for investigation and corrective actions based on the information provided by the site(s)
Other duties as assigned

What we offer

Great benefits (healthcare, health & personal spending accounts, wellness days, Employee & Family Assistance Program)
Company provided RRSP
Loyalty share program (based on service length)
$200.00 safety boot voucher & company provided PPE
$300.00 per year to spend on company products
Employee discount pricing
Employee appreciation events & rewards
Free onsite parking
Bus pass reimbursement
Exclusive discounts with various suppliers

Fulltime

Manufacturing Process Technician

As a Manufacturing Process Technician, you will report into the Shift Manager. I...

Location

Ireland , Dun Laoghaire

Salary:

39477.40 - 53410.60 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Pass Leaving Certificate standard or equivalent - required
A third level qualification in a relevant subject area - preferred
Minimum 12 months experience of operations within a sterile pharmaceutical manufacturing or similar environment OR Minimum 2 years of experience in a GMP and / or equivalent regulated environment
Demonstrated knowledge of GMP principles and aseptic knowledge within GMP areas
Aseptic experience preferred
Drug product manufacturing experience
Experience working with equipment utilized in the manufacture of parenteral products such as autoclaves, filling lines and formulation vessels
Demonstrated understanding and use of Right First Time (RFT) techniques and lean manufacturing concepts
Demonstrated mechanical aptitude
Excellent problem-solving and communication skills

Job Responsibility

Set up of manufacturing equipment, processing of parts and components for manufacturing, performing transactions in electronic systems such as EBR, LIMS, etc. and cleaning and sanitization of production areas
Perform duties with due care and in accordance with Good Manufacturing Practices (GMP), Safety Regulations and Amgen requirements
Problem solving and troubleshooting, including initiation and documentation of investigations
Performance of self-inspection during Quality & Safety Audits
Support Corporate, FDA, IMB Auditors and other regulatory bodies during company audits
Participate in the learning and development program via the Maximizing Amgen Performance (MAP) process
Support cross functional training across team members
Ownership for the use, review, revision and upgrade of operational documentation and peer review of operations
Play a key role in the development of manufacturing systems
Proactively identify operational improvement and continuous improvement opportunities and / or process related issues including escalation & follow up for effective resolution and implementation

What we offer

Retirement and savings plan with generous company contributions
Group medical, life and disability insurance
Discretionary annual bonus program
Exceptional learning, development and career advancement opportunities

Fulltime

Quality Associate II

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

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS in business/science or equivalent degree
3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
Strong interpersonal skills and great attention to detail are necessary
Must be a team player with good problem solving, and good verbal and written communication skills
Must be able to handle multiple projects concurrently
Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Knowledge of and experience with outside the US regulatory requirements is desirable
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials

Job Responsibility

Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System
Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements
Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required
Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes
Prepares and publishes annual product reviews
Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
Schedules and plans for the audit activity by researching background information, including previous audit results
Plans and develops assessment strategy and logistics
Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks
Reports findings (verbally and written) to management

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Qpi Expert – Audit Management Lead

We are looking for an experienced QPI Expert – Audit Management Lead to drive au...

Location

France

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

8+ years of experience in Quality within the pharmaceutical industry
Strong exposure to Pharmacovigilance (PV)
Qualified GVP Auditor with solid QMS expertise
Good understanding of regulatory frameworks (ICH, GCP, ISO standards)
Fluent in English
French (preferred)
Strong stakeholder management and client-facing skills

Job Responsibility

Define and implement the annual internal and vendor audit strategy
Lead internal, vendor, and client audits
manage findings and CAPAs
Act as key contact for client auditors and health authority inspections
Develop, maintain, and continuously improve the QMS (including ISO 9001 alignment)
Oversee SOPs, controlled documentation, and quality tracking systems
Drive process improvements and ensure compliance with ICH, GCP, GVP, and local regulations
Manage vendor quality oversight and risk-based audit programs
Lead and mentor a small team (1–3 members) and collaborate cross-functionally

Fulltime

Quality Associate II

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

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS in business/science or equivalent degree
3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
Strong interpersonal skills and great attention to detail are necessary
Must be a team player with good problem solving, and good verbal and written communication skills
Must be able to handle multiple projects concurrently
Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Knowledge of and experience with outside the US regulatory requirements is desirable
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials

Job Responsibility

Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System
Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements
Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required
Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes
Prepares and publishes annual product reviews
Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
Schedules and plans for the audit activity by researching background information, including previous audit results. Plans and develops assessment strategy and logistics
Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management
Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure
Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Quality Associate II

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

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS in business/science or equivalent degree
3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
Strong interpersonal skills and great attention to detail are necessary
Must be a team player with good problem solving, and good verbal and written communication skills
Must be able to handle multiple projects concurrently
Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Knowledge of and experience with outside the US regulatory requirements is desirable
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials

Job Responsibility

Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
Schedules and plans for the audit activity by researching background information, including previous audit results. Plans and develops assessment strategy and logistics
Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management
Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure
Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes
Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective
Trains and mentors new auditors and manages the guest auditor program
Supports management of external inspections. Tracks and reports the status of external commitments through closure
Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes as required. Documents and tracks action items and follow-up commitments to closure
Leads and manages multiple projects/teams including corporate quality policy & procedure gap analysis and implementation, the global audit observation certification process, Annual Product Reviews, SOP and training code audits, and other quality system improvement projects

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

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Quality Auditor - Pharmaceutical

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