Top 203 Quality & regulatory specialist Jobs in Columbus

Quality Assurance Specialist - Complaints
BI Pharmaceuticals, Inc. —Columbus, OH
- Full-time
- Hybrid work
- Microsoft Word
- 7 years
- Microsoft Excel
Specialist, Quality Operations
Safecor Health —Columbus, OH
- English
- Mid-level
- 3 years
5d
Payroll Specialist
G Mechanical Inc —Columbus, OH
- $28 - $30 an hour
- Full-time
- Mid-level
- Office
- Microsoft Office
- Health insurance
- Dental insurance
Quick Apply
6d
PURCHASING SPECIALIST - CUSTOMS, LOGISTICS & TARIFFS
Stanley Electric U.S. —London, OH
- $60,000 - $70,000 a year
- Research
- Mid-level
- Office
- Health insurance
- Dental insurance
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Electrical Engineer - Medical Device Solutions
Battelle —Columbus, OH
- Full-time
- Hybrid work
- Mid-level
- Office
- Travel
- Wellness program
- Health insurance
Senior Client Relationship Representative
First Merchants Bank —Columbus, OH
- Office
- High school diploma or GED
- Business development
- Paid parental leave
- Paid holidays
Quick Apply
Program Manager, Therapeutic & Pre-school Educational Services
St. Vincent Family Center —Columbus, OH
- $60,000 - $70,000 a year
- Full-time
- Microsoft Outlook
- Customer service
- LPC
- Health savings account
- Health insurance
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Tissue Specialist I - 30274
BEPC Inc —Columbus, OH
- $17.00 - $17.74 an hour
- Contract
- Background check
- High school diploma or GED
- Continuous improvement
- Health insurance
- Dental insurance
Quick Apply
Product Engineer II
Mettler Toledo —Columbus, OH
- Bachelor of Science
- Mid-level
- Analysis skills
- Disability insurance
- Health insurance
Medical Director - Psychiatrist - Columbus OH
The Recovery Village —Columbus, OH
- $350,000 - $400,000 a year
- Full-time
- Medicine
- Psychiatry
- Addiction Medicine
- Health savings account
- Paid holidays
Quick Apply
Quality Improvement Specialist
PrimaryOne Health —Columbus, OH
- RN License
- Mid-level
- Travel
- Paid holidays
- Disability insurance
Quality Assurance Specialist
Klarna Bank AB —Columbus, OH
- $75,281 - $84,315 a year
- Full-time
- English
- Finance
- Analysis skills
- Health insurance
- Dental insurance
5d
Research Assistant
OhioHealth —Columbus, OH
- Full-time
- Microsoft Excel
- Microsoft Outlook
- High school diploma or GED
Manager, Talent Acquisition
Abbott Laboratories —Columbus, OH
- $99,300 - $198,700 a year
- Full-time
- Office
- 3 years
- Analysis skills
- Health insurance
- Tuition reimbursement
Quality Specialist
US AMR-Jones Lang LaSalle Americas, Inc. —New Albany, OH
- $67,000 - $97,000 a year
- Online Application
- Word processing
- Computer literacy
- Mid-level
- Paid parental leave
- Paid holidays
Quick Apply
Pharmacovigilance Specialist I, II, III
Gifthealth Inc —Columbus, OH
- $68,000 - $92,000 a year
- Full-time
- Hybrid work
- Nursing
- Mid-level
- Bachelor's degree
Quick Apply
NERC Compliance Specialist
AEP Service Corporation —New Albany, OH
- $87,633 - $128,688 a year
- Full-time
- Computer Science
- Mid-level
- Office
- Tuition reimbursement
7d
Financial Crime Compliance Specialist
Klarna Bank AB —Columbus, OH
- $105,394 - $132,206 a year
- Full-time
- English
- Analysis skills
- Senior level
- Health insurance
- Dental insurance
5d
Commercial Lines Quality Assurance Specialist (hybrid/remote)
Grange Insurance Company —Columbus, OH
- Remote
- 5 years
- Analysis skills
- Bachelor's degree
- Bereavement leave
8d
Health Informatics Specialist I- Hybrid - Delaware, Penn, Maryland
Trinity Health —Delaware, OH
- $75,592 - $113,389 a year
- Full-time
- Hybrid work
- Office
- Analysis skills
- Bachelor's degree

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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 & regulatory specialist jobs in columbus

Quality Assurance Specialist - Complaints

Specialist, Quality Operations

Payroll Specialist

PURCHASING SPECIALIST - CUSTOMS, LOGISTICS & TARIFFS

Electrical Engineer - Medical Device Solutions

Senior Client Relationship Representative

Program Manager, Therapeutic & Pre-school Educational Services

Tissue Specialist I - 30274

Product Engineer II

Medical Director - Psychiatrist - Columbus OH

Quality Improvement Specialist

Quality Assurance Specialist

Research Assistant

Manager, Talent Acquisition

Quality Specialist

Pharmacovigilance Specialist I, II, III

NERC Compliance Specialist

Financial Crime Compliance Specialist

Commercial Lines Quality Assurance Specialist (hybrid/remote)

Health Informatics Specialist I- Hybrid - Delaware, Penn, Maryland

I want to receive the latest job alert for quality & regulatory specialist in columbus

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