Top 108 Development & manufacturing specialist Jobs in Columbus

Quality Assurance Specialist - Complaints
BI Pharmaceuticals, Inc. —Columbus, OH
- Full-time
- Hybrid work
- Microsoft Word
- 7 years
- Microsoft Excel
Document Control Specialist
Quanta Services —Columbus, OH
- Customer service
- Computer literacy
- Writing skills
- Paid parental leave
- Health savings account
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Cintas —Columbus, OH
- Full-time
- Microsoft Excel
- Microsoft Outlook
- High school diploma or GED
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Production & Workforce Training Manager
Columbus Fashion Alliance —Columbus, OH
- $55,000 - $60,000 a year
- Email
- Mid-level
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- Recruiting
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- Health insurance
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Robotic Operations Support Specialist, weekend shift
Path Robotics —Columbus, OH
- $60,000 - $72,000 a year
- Full-time
- Spanish
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- Bachelor of Science
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Electrical Engineer - Medical Device Solutions
Battelle —Columbus, OH
- Full-time
- Hybrid work
- Mid-level
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Product Engineer
Mettler Toledo —Columbus, OH
- Bachelor of Science
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Automotive Manufacturing Technical Opportunities – Astemo (Delaware, OH)
Astemo Americas Inc —Sunbury, OH
- $17 - $45 an hour
- Overtime
- Background check
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- Computer literacy
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1d
Commercial Hood Cleaning Technician - Overnight Shift
Nelbud —Columbus, OH
- $18 an hour
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- Clean driving record
- Customer service
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14d
Technician Specialist - Flammability
TS TECH —Reynoldsburg, OH
- Full-time
- Background check
- Microsoft Outlook
- Office
- Health savings account
- Relocation assistance
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Maintenance Specialist
Novolex —Columbus, OH
- $29.45 - $36.50 an hour
- Urgently hiring
- Mid-level
- 3 years
- High school diploma or GED
- Health insurance
- Dental insurance
Business Development Specialist Engineering & Facilities Maintenance
On-Board Companies —Columbus, OH
- $50 - $60 an hour
- Full-time
- Office
- 3 years
- Ability to climb stairs
- Paid holidays
- Health insurance
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Project Cost Controls Specialist (Columbus, OH)
Quanta Infrastructure Solutions Group, LLC —Columbus, OH
- Full-time
- Mid-level
- Office
- Finance
- Paid holidays
- Health insurance
EHS Specialist
Charter Next Generation —Delaware, OH
- Full-time
- Research
- 1 year
- Senior level
- Paid holidays
- Health insurance
Quick Apply
Management Consulting Delivery Specialist , Scientific and Laboratory Informatics
Accenture —Columbus, OH
- $59,100 - $196,000 a year
- Full-time
- Computer Science
- Up to 50% travel
- Laboratory experience
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- Disability insurance
Document Control Specialist
Quanta Infrastructure Solutions Group, LLC —Columbus, OH
- Full-time
- Customer service
- Computer literacy
- Writing skills
- Paid parental leave
- Health savings account
Principal Specialist, Quality Assurance - Microbiology
Cardinal Health —Lewis Center, OH
- $80,900 - $103,950 a year
- Bachelor's degree
- No degree
- Mentoring
- Paid parental leave
- Health savings account
9d
QA Calibration Specialist
Eliquent Life Sciences, Inc —Columbus, OH
- $90,000 - $110,000 a year
- Full-time
- 5 years
- Engineering
- Continuous improvement
- Health insurance
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Entry Level Systems Engineer/Controls Specialist
RoviSys Building Technologies —Dublin, OH
- $80,000 - $82,000 a year
- Full-time
- System design
- Office
- Assembly
- Health insurance
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Health, Safety & Environmental Specialist
Mars —Columbus, OH
- Full-time
- Hybrid work
- Mid-level
- Analysis skills
- Bachelor's degree
9d

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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

development & manufacturing specialist jobs in columbus

Quality Assurance Specialist - Complaints

Document Control Specialist

Inventory Management Specialist

Production & Workforce Training Manager

Robotic Operations Support Specialist, weekend shift

Electrical Engineer - Medical Device Solutions

Product Engineer

Automotive Manufacturing Technical Opportunities – Astemo (Delaware, OH)

Commercial Hood Cleaning Technician - Overnight Shift

Technician Specialist - Flammability

Maintenance Specialist

Business Development Specialist Engineering & Facilities Maintenance

Project Cost Controls Specialist (Columbus, OH)

EHS Specialist

Management Consulting Delivery Specialist , Scientific and Laboratory Informatics

Document Control Specialist

Principal Specialist, Quality Assurance - Microbiology

QA Calibration Specialist

Entry Level Systems Engineer/Controls Specialist

Health, Safety & Environmental Specialist

I want to receive the latest job alert for development & manufacturing specialist in columbus

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