Top 593 Quality liaison Jobs in Columbus Oh

Quality Assurance Specialist - Complaints
BI Pharmaceuticals, Inc. —Columbus, OH
- Full-time
- Hybrid work
- Microsoft Word
- 7 years
- Microsoft Excel
Automotive Service Manager
Confidential —Columbus, OH
- $100,000 - $120,000 a year
- Full-time
- Background check
- Dealership
- Pass drug screening
- Health savings account
- Health insurance
Quick Apply
INJECTION MOLDING MAINTENANCE TECH III - 1ST, 2ND & 3RD SHIFTS
Stanley Electric U.S. —London, OH
- $35.27 an hour
- Overtime
- Office
- 8 years
- Organizational skills
- Health insurance
- Dental insurance
Quick Apply
Occupational Therapist
The Ohio State University Wexner Medical Center —Columbus, OH
- Online Application
- Acute care
- Background check
- Hospital
Medical Director / Hospice PRN
Transitions Hospice - Ohio —Columbus, OH
- $150 - $160 an hour
- PRN
- Medicine
- Conflict management
- Hospice
- Fuel card
- Disability insurance
Quick Apply
12d
Traveling Bath Installation Tranier
SageHome Brands LLC —Columbus, OH
- $85,000 - $95,000 a year
- Full-time
- Bilingual
- Clean driving record
- Construction site
Quick Apply
6d
Director - Histocompatibility Lab
The Ohio State University Wexner Medical Center —Columbus, OH
- Online Application
- Background check
- Pass drug screening
- Doctor of Philosophy
Respiratory Therapist Clinical Lead - NICU - $7,000 Signing Bonus
The Ohio State University Wexner Medical Center —Columbus, OH
- Online Application
- Background check
- Pass drug screening
- Mid-level
Restoration Project Manager
Confidential —Columbus, OH
- $85,000 - $100,000 a year
- Full-time
- Background check
- Microsoft Excel
- Construction site
- Fuel card
- Health insurance
Quick Apply
AVP, Fund Compliance - Mutual Funds
Ultimus Fund Solutions —Columbus, OH
- $75,000 - $100,000 a year
- Full-time
- Writing skills
- Office
- 3 years
Quick Apply
INDUSTRIAL MAINTENANCE TECH I - V, 3RD SHIFT
Stanley Electric U.S. —London, OH
- $27.00 - $35.85 an hour
- Overtime
- Customer service
- Mid-level
- Office
- Dental insurance
- Tuition reimbursement
Quick Apply
INDUSTRIAL MAINTENANCE TECH I - V, 2ND SHIFT
Stanley Electric U.S. —London, OH
- $27.00 - $35.85 an hour
- Overtime
- Customer service
- Mid-level
- Office
- Dental insurance
- Tuition reimbursement
Quick Apply
Engineering/CAD Supervisor
Distinctive Marble & Granite —Plain City, OH
- $55,000 - $70,000 a year
- Full-time
- AutoCAD
- Mid-level
- High school diploma or GED
- Health savings account
- Health insurance
Quick Apply
19h
Clinical Liaison ( RN , RT )
Select Specialty Hospital - Columbus Vic Village(Grant) —Columbus, OH
- $70,000 - $95,000 a year
- Full-time
- RN License
- Hospital
- Mid-level
- Dental insurance
- Paid time off
Quick Apply
Assistance Maintenance Manager
ReOpOhio LLC (Real Estate Opportunity) —Columbus, OH
- $55,000 - $65,000 a year
- Full-time
- Mid-level
- Driver's License
- Data entry
- Dental insurance
- 401(k)
Quick Apply
23h
Delaware County Juvenile Court Liaison
Syntero, Inc —Delaware, OH
- $47,840 - $66,560 a year
- Full-time
- LMFT
- Mid-level
- Master's degree
- Health insurance
- Dental insurance
Quick Apply
HVAC Field Service Technician III
F6 Data Solutions —Columbus, OH
- $49 - $60 an hour
- Extended hours
- Management
- Construction site
- 5 years
- Health insurance
- Dental insurance
Quick Apply
Project Manager - Municipal, Public Construction Projects
Michael Page —Columbus, OH
- $100,000 - $130,000 a year
- Mid-level
- Mentoring
- Contracts
- Health insurance
- Paid time off
7d
Construction Project Manager
Jess Howard Electric —Blacklick, OH
- $90,000 - $120,000 a year
- Microsoft Excel
- Microsoft Outlook
- Construction site
- Paid holidays
- Disability insurance
Quick Apply
Construction Superintendent
MAC Construction —Worthington, OH
- $100,000 - $115,000 a year
- Full-time
- Background check
- 7 years
- 6 years
- Fuel card
- Health savings account
Quick Apply
1d

I want to receive the latest job alert for quality liaison in columbus oh

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 liaison jobs near columbus oh

Medical Director jobs in Columbus, OH

Assistant Vice President jobs in Columbus, OH

Automotive Service Manager jobs in Columbus, OH

Laboratory Director jobs in Columbus, OH

Occupational Therapist jobs in Columbus, OH

Installer jobs in Columbus, OH

Respiratory Therapist jobs in Columbus, OH

Maintenance Manager jobs in Columbus, OH

Construction Project Manager jobs in Columbus, OH

Clinical Liaison jobs in Columbus, OH

Quality Assurance Specialist jobs in Columbus, OH

Restoration Project Manager jobs in California

Project Coordinator jobs in Phoenix, AZ

Restoration Project Manager jobs in Cypress, TX

Restoration Project Manager jobs in Warwick, RI

Restoration Project Manager jobs in Virginia Beach, VA

Case Manager jobs in Tampa, FL

Construction Project Manager jobs in Frederick, MD

Office Manager jobs in Connecticut

Band Director jobs in Tennessee

Quality Assurance Specialist - Complaints

BI Pharmaceuticals, Inc. -
Columbus, OH

Apply Now

Job Details

Full-time

Qualifications

USP standards
Pharmaceutical regulatory compliance
Drug regulation
Corrective and preventive actions (CAPA)
Project management
Bachelor's degree
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Document quality checks
Escalation handling
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

The Quality Assurance Specialist (Complaints and Approval to Distribute) is a champion of accountability, agility, and intrapeneurship (AAI) behaviors and Quality Culture. This role ensures quality and compliance to regulations and internal procedures with respect to Complaint Handling and Approval to Distribute. The incumbent will assist as needed with Field Alert Reports (FARs), Biologic Product Deviation Reports (BPDRs), market actions, and Product Safety and Security. This role is responsible for ensuring that batches manufactured by Contract Manufacturing Organizations (CMOs) and BI OPUs for products to be distributed in the US meet the requirements for approval to distribute as well as responsible for escalating any critical events to Management in a timely manner.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

This role is based on-site at our Columbus, OH location with hybrid flexibility of 2-3 days per week on-site.

Duties & Responsibilities

Partners with Third Party Quality Management (3PQM), Contract Manufacturing Organizations (CMOs), and BI OPUs to ensure that complaints are properly investigated and accurately documented within the global complaint system. Ensures the root cause or most probable root cause of reported complaint has been determined
Collaborates with BI OPUs, 3PQM and CMOs as needed to review and/or recommend sustainable Corrective Action/Preventive Actions (CAPAs) to be implemented at impacted sites
Reviews, approves/closes customer complaints ensuring that the investigation meets acceptable quality standards including but not limited to established time lines. Focus is on complaints with market action potential, however will also support closure of other complaint investigations as needed.
Supports international Quality initiatives/projects:
Acts as Local Pharmaceutical Complaint Officer (LPCO).
Responsibilities include but not limited to:
Ensuring that all complaints received at the local level are entered into the company's complaint system, categorized and assigned to the appropriate investigation site within established timelines including interaction with the complainant, the Corporate Pharmaceutical Complaint Officer and potentially with local health authorities; regularly performs complaint trending and issues complaint reports.
Collaborates with other LPCOs and Deputy LPCOs on global continuous process improvement initiatives.
Represents BIPI at internal and external forums on complaint management.
Responsible for complaint trending evaluation, leads functional team meetings to ensure that Critical Events are known to local Quality management.
Provides complaint data to and participates in monthly cross functional Quality Management Review (QMR) meeting and monthly 3PQM QMR to ensure site is aware of complaints within US Marketed products
Collaborates with others within Quality Assurance to ensure complaint process is of high quality and adheres to established time lines.
Actively participates in alignment calls with BIPI-Ridgefield, HPSG, and Complaint MSO to drive continuous process improvements.
Local contact partner/liaison for Brand Safety & Security initiatives
Independently performs batch record review and/or final disposition of drug products manufactured by CMOs and BI OPUs ensuring that the batch was produced in compliance with specifications, cGMPS and corporate policies and procedures.
Possesses the authority to make batch disposition (approval to distribute, reject) decisions and address non-standard events and documentation errors with CMOs. Errors in decision making can result in market action such as product recall and/or interruption in the supply chain, therefore ability to meet the market demands.
Prioritizes work to ensure no interruption to supply chain. First line of contact for escalation of potential problems with product or meeting market needs. Escalates to management any potential interruption to the supply chain when recognized.
Acts as a representative on cross-functional teams that require batch disposition input. Investigates and resolves inter-company deviations that impact batch prior to disposition.
Completes the ERP transactions associated with the batch decision.
Travel as required for position and assigned projects/tasks. Domestic and International travel ~20%

Requirements

BS/BA in Chemistry, Pharmacy, or related science Diploma with additional years of experience.
Minimum five (5) years’ experience with BS/BA pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
Diploma and seven (7) years’ experience in pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
Ability to respond and act appropriately with all levels under time pressure and regulatory scrutiny. For example, ability to evaluate quality issues and make strategic decisions to minimize the quality and business impact of product batches and campaigns. Escalates and collaborates with quality management to resolve trends impacting product quality.
Demonstrated knowledge of FDA, cGMP, EU regulations, and USP. Emphasis on management of current good manufacturing practices programs.
Demonstrated effectively applying cGMP and quality system regulations within the pharmaceutical industry.
Demonstrated knowledge of Quality Assurance, Production, Laboratories or Regulatory functions within a pharmaceutical environment.
Excellent communication skills with the ability to influence/persuade individuals.
Ability to utilize active listening skills to understand the concerns or reasoning to be responsive, gain trust, and build strategic relationships.
Project management expertise to arrive at quality effective and efficient processes that contribute to product quality.
Experience using Microsoft applications (Word, Excel) and ERP is preferred.
Demonstrated investigative techniques to uncover problem areas and recommend corrective actions.
Problem solving ability requiring attention to detail, accuracy, cGMP, and scientific judgment.

Apply Now

Refine Your Search

quality liaison jobs in columbus oh

Quality Assurance Specialist - Complaints

Automotive Service Manager

INJECTION MOLDING MAINTENANCE TECH III - 1ST, 2ND & 3RD SHIFTS

Occupational Therapist

Medical Director / Hospice PRN

Traveling Bath Installation Tranier

Director - Histocompatibility Lab

Respiratory Therapist Clinical Lead - NICU - $7,000 Signing Bonus

Restoration Project Manager

AVP, Fund Compliance - Mutual Funds

INDUSTRIAL MAINTENANCE TECH I - V, 3RD SHIFT

INDUSTRIAL MAINTENANCE TECH I - V, 2ND SHIFT

Engineering/CAD Supervisor

Clinical Liaison ( RN , RT )

Assistance Maintenance Manager

Delaware County Juvenile Court Liaison

HVAC Field Service Technician III

Project Manager - Municipal, Public Construction Projects

Construction Project Manager

Construction Superintendent

I want to receive the latest job alert for quality liaison in columbus oh

Related Searches

Explore jobs in more locations

Duties & Responsibilities

Requirements

Job Seeker Tools

Employer Tools

Browse

Stay Connected