Manager, Quality Assurance Auditor
Fresenius Kabi —Melrose Park, IL
- $125,000 - $135,600 a year
- Full-time
- Hybrid work
- Background check
- 5 years
- Master's degree
- Wellness program
- Paid holidays
Quick Apply
16h
Quality Assurance Manager
Confidential —Chicago, IL
- From $70,000 a year
- Full-time
- Management
- 5 years
- Office
- Health insurance
- Dental insurance
Quick Apply
Quality Control Manager
Lily and Fox —Arlington Heights, IL
- $70,000 - $90,000 a year
- Weekends as needed
- Background check
- 18 years or older
- Basic math
- Disability insurance
- Health insurance
Quick Apply
Production Quality Manager
Lily and Fox —Arlington Heights, IL
- $70,000 - $90,000 a year
- Weekends as needed
- Background check
- 18 years or older
- Basic math
- Disability insurance
- Health insurance
Quick Apply
Quality Control Manager
SERENITY HOME HEALTH CARE —Niles, IL
- $20 - $22 an hour
- Full-time
- Bilingual
- Spanish
- Customer service
- Health insurance
- Dental insurance
Quick Apply
Print Quality Manager
Lily and Fox —Arlington Heights, IL
- $70,000 - $90,000 a year
- Weekends as needed
- Background check
- 18 years or older
- Basic math
- Disability insurance
- Health insurance
Quick Apply
Quality Manager
DRC Heat Transfer —Melrose Park, IL
- Full-time
- Background check
- Management
- Bachelor's degree
- Health savings account
- Health insurance
Quick Apply
1d
QC Manager (CQC System Manager) - Government Construction
The Povolny Group, Inc. —North Chicago, IL
- Full-time
- Construction site
- 5 years
- Computer literacy
- Health savings account
- Paid holidays
Quick Apply
Quality Assurance / Quality Control Manager
Spectra-Tech, Inc. —Hanover Park, IL
- From $75,000 a year
- Full-time
- Management
- Mid-level
- US work authorization
- Health insurance
- 401(k)
Quick Apply
2d
SAP - Delivery Excellence - Delivery Manager - Location OPEN
EY —Chicago, IL
- $142,600 - $297,200 a year
- Analysis skills
- Bachelor's degree
- Continuous improvement
- Paid holidays
- Health insurance
Quality Supervisor
Destaco —Wheeling, IL
- $80,000 - $100,000 a year
- Full-time
- Microsoft Excel
- Oracle
- Customer service
- Health insurance
- Dental insurance
Quick Apply
DIRECTOR OF QUALITY ASSURANCE AND FOOD SAFETY
The Judge Group —Long Grove, IL
- $160,000 - $180,000 a year
- Full-time
- Microsoft Outlook
- Management
- Bachelor's degree
Quick Apply
Senior Quality Manager
M. A. Mortenson Company —Chicago, IL
- $116,900 - $175,400 a year
- 7 years
- Driver's License
- Team management
- AD&D insurance
- Paid holidays
Quality Manager
Axion Recruitment —Barrington, IL
- $90,000 a year
- Full-time
- Bilingual
- Management
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
2d
Product Quality Manager
Lily and Fox —Arlington Heights, IL
- $70,000 - $90,000 a year
- Weekends as needed
- Background check
- 18 years or older
- Basic math
- Disability insurance
- Health insurance
Quick Apply
Global Product Inspection and Quality Manager
Lily and Fox —Arlington Heights, IL
- $70,000 - $90,000 a year
- Weekends as needed
- Background check
- 18 years or older
- Basic math
- Disability insurance
- Health insurance
Quick Apply
Quality Assurance Supervisor - Batavia, IL
EAGLE FLEXIBLE PACKAGING —Batavia, IL
- $25 - $40 an hour
- Full-time
- Spanish
- Ability to walk for extended periods
- Engineering
- Health savings account
- Paid holidays
Quick Apply
Construction Quality Control Manager
MEDC: Tribal One —Darien, IL
- $115,000 - $130,000 a year
- Full-time
- CPR Certification
- Construction site
- Driver's License
- Disability insurance
- Health insurance
Quick Apply
18h
Lead Compliance Engineer
HARTING Manufacturing Inc. —Elgin, IL
- $110,000 - $130,000 a year
- Bachelor of Science
- Research
- 3 years
- Paid parental leave
- AD&D insurance
Quick Apply
Quality Control Manager **Direct Hire**
IPCC —Lake Forest, IL
- From $75,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Management
- Health insurance
- Dental insurance
Quick Apply
2d

I want to receive the latest job alert for quality manager in des plaines il

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

quality manager jobs near des plaines il

Manager, Quality Assurance Auditor

Fresenius Kabi -
Melrose Park, IL

Quick Apply

Job Details

Full-time
$125,000 - $135,600 a year
16 hours ago

Benefits

Wellness program
Paid holidays
Health insurance
Dental insurance
401(k)
Employee assistance program
Vision insurance
Life insurance

Qualifications

Content creation for technical audiences
Team supervision
Technical documentation
ISO standards
Technical writing within manufacturing
GMP
Quality control audit
Project management
Bachelor's degree
Quality assurance within pharmaceutical industry
Quality inspection
Leading team collaboration initiatives
Internal compliance assessments
Biomedical regulatory compliance
Aseptic technique
Regulatory compliance analysis
FDA regulations

Full Job Description

Job Summary

The Manager, Quality Assurance Auditor is responsible for scheduling and leading domestic and international Corporate and Regional Compliance Audits, including internal audits of Fresenius Kabi facilities and external audits of Fresenius Kabi suppliers in accordance with Fresenius Kabi policies and procedures. Identifies top compliance risks and communicates to Fresenius Kabi Management. Must be able to function independently with limited supervision
Processes complaints to ensure timely and accurate evaluation and completion of customer complaints. May back up the US Vigilance Team with submissions of Field Alert Reports (FAR) and Medical Device Reports (MDR) as required to comply with all regulatory obligations. Create reports used for Key Process Indicators (KPI) and aids in the processing of complaints.

Salary Range: Job Posting Range: $125K - $135,600

Position is eligible to participate in a bonus plan with a target of 10% of the base salary (include only if applicable to the grade level)
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Hybrid role: Onsite 3 days per week

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Responsibilities

Lead internal audits of Fresenius Kabi facilities based on the FDA’s System Based Inspection Policy and GMP and other GxP. Develop audit plans, conduct quality audits, prepare audit reports, and communicate findings, including compliance risk. Lead / participate in Global / Divisional internal audits of Fresenius Kabi facilities as required. Develop audit plans, conduct quality audits, prepare audit reports, and communicate findings to Fresenius Kabi management. Review and evaluate internal audit response against Fresenius Kabi’s policies and procedures requirements, current industry standards, regulations, and guidelines to assure compliance. Drive closure of corrective and preventive actions to ensure implementation, compliance, and continuing efficacy. Lead gap assessment audits and PAI readiness inspections at Fresenius Kabi USA facilities as needed. External Audits Lead external audits of Fresenius Kabi suppliers (Contract Manufacturers, APIs, Excipients, Primary and Secondary Packaging, Contract Laboratories, and all Services). Develop audit plans, conduct quality audits, prepare audit reports, and communicate findings, including compliance risk. Recommends approval or disapproval of suppliers based on compliance assessment. Review and evaluate supplier’s audit response against current industry standards, regulations, and guidelines to assure compliance. Drive closure of corrective and preventive actions to assure sufficient controls are in place by the supplier to meet Fresenius Kabi specifications and quality requirements. Follow up on prior audit recommendations to ensure implementation and compliance. Assist in maintenance of the annual internal and external audit schedules as requested by management. Lead For-Cause audits of external suppliers as requested by management. Lead and / or assist the development of compliance and quality training as required. Revise, review, and write SOPs and checklists to ensure documentation defines the steps necessary to complete required audit tasks. Maintain audit files and databases to ensure all documentation is current, complete, and accurate. Assumes additional duties and responsibilities as assigned.

All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements

Minimum of a bachelor’s degree in sciences (Masters or higher preferred) with a minimum of 5 years of progressive, challenging QA/QC experience in pharmaceutical or biotechnology industries preferred, but combination with medical device experience is acceptable. Certificate as a CQA Auditor, CQE, etc. is preferred.

Must have at least 5+ years of extensive experience in pharmaceutical and / or biotechnology quality audits including both external and internal auditing. At least five (5) years of FDA system-based inspection is required. In-depth knowledge of Aseptic Processing, GMP and other GxP regulations.

Requires a display of in-depth understanding of FDA trends, FDA and EU regulations and guidelines, and ISO 9001 standard. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations.

Proven ability to lead teams and handle project management activities without supervision.

Must be flexible and able to travel domestically and / or internationally up to 50% of the time.

Must demonstrate effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities / assignments.

• Must demonstrate effective communication skills and technical writing ability.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Work Location: Hybrid remote in Melrose Park, IL 60160

Quick Apply

Refine Your Search

quality manager jobs in des plaines il

Manager, Quality Assurance Auditor

Quality Assurance Manager

Quality Control Manager

Production Quality Manager

Quality Control Manager

Print Quality Manager

Quality Manager

QC Manager (CQC System Manager) - Government Construction

Quality Assurance / Quality Control Manager

SAP - Delivery Excellence - Delivery Manager - Location OPEN

Quality Supervisor

DIRECTOR OF QUALITY ASSURANCE AND FOOD SAFETY

Senior Quality Manager

Quality Manager

Product Quality Manager

Global Product Inspection and Quality Manager

Quality Assurance Supervisor - Batavia, IL

Construction Quality Control Manager

Lead Compliance Engineer

Quality Control Manager Direct Hire

I want to receive the latest job alert for quality manager in des plaines il

Related Searches

Explore jobs in more locations

Job Summary

Responsibilities

Additional Information

Job Seeker Tools

Employer Tools

Browse

Stay Connected