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Jobs at Exela Pharma Sciences LLC (Now Hiring) — 8 open

Exela Pharma Sciences LLC logoExela Pharma Sciences LLC

Paralegal

Lenoir, North Carolina, United States · On-site

Mid level

Position Summary Exela Pharma Sciences is seeking a highly motivated, detail-oriented and assertive individual to join our fast-growing company in this non-traditional, yet highly fulfilling career track. The ideal candi…

Skills: Contract Management, Regulatory Compliance, Document Management, FDA Regulations, Time Management

Exela Pharma Sciences LLC logoExela Pharma Sciences LLC

Manager, Visual Inspection

Lenoir, North Carolina, United States · On-site

Senior+

Position Summary The Visual Inspection Manager is responsible for leading the development, execution, and continuous improvement of the site’s Visual Inspection Program in support of pharmaceutical manufacturing op…

Skills: Visual Inspection, Defect Standards, Particulate Control, AQL Strategy, Reinspection Processes

Exela Pharma Sciences LLC logoExela Pharma Sciences LLC

Senior Laboratory Systems Analyst

Lenoir, North Carolina, United States · On-site

Senior

Position Summary The Senior Laboratory Systems Analyst serves as the primary Information Systems business partner supporting Exela's Quality Control, Microbiology, Quality Assurance, and Research & Development laboratori…

Skills: LabVantage LIMS, Moda ES, Moda EM, Laboratory Instrument Integration, Computerized System Validation

Exela Pharma Sciences LLC logoExela Pharma Sciences LLC

Production Supervisor (Nights/Weekends)

Lenoir, North Carolina, United States · On-site

Mid level

Position Summary: The Supervisor, Production is responsible for leading daily production personnel activities and completing associated documentation in support of producing pharmaceutical products in compliance with all…

Skills: Aseptic Practices, Cleanroom Behavior, cGMP, SOP Compliance, Employee Coaching

Exela Pharma Sciences LLC logoExela Pharma Sciences LLC

Director, Quality Operations

Lenoir, North Carolina, United States · On-site

Senior+

Position Summary The Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ultimately responsible for the product quality received by the cust…

Skills: Quality Management System, ISO 13485, 21 CFR Part 820, Risk Management, Process Validation

Exela Pharma Sciences LLC logoExela Pharma Sciences LLC

Plant Manager

Lenoir, North Carolina, United States · On-site

Senior

Position Summary We are seeking a dynamic and experienced Plant Manager to oversee our manufacturing operations. The ideal candidate will have a strong background in Food & Beverage or Automotive production, leadership s…

Skills: Operations Management, Team Leadership, Safety Compliance, Quality Assurance, Continuous Improvement

Exela Pharma Sciences LLC logoExela Pharma Sciences LLC

Senior Microbiologist

Lenoir, North Carolina, United States · On-site

Senior

Position Summary The Senior Microbiologist serves as a technical leader within the Microbiology laboratory, responsible for advanced microbiological testing, complex troubleshooting, and oversight of laboratory investiga…

Skills: Microbiological Testing, Environmental Monitoring, Root Cause Analysis, CAPA, cGMP

Exela Pharma Sciences LLC logoExela Pharma Sciences LLC

Microbiologist I (12 hour nights or Weekends or 2p-11p)

Lenoir, North Carolina, United States · On-site

Entry level

Position Summary The Microbiologist I will perform Microbiological laboratory testing associated with Environmental Monitoring (EM), Water for Injection (WFI), and product specific Microbiological samples. Additionally, …

Skills: Microbiological Testing, Environmental Monitoring, Aseptic Technique, cGMP, cGLP

Exela Pharma Sciences LLC logo

Paralegal

Exela Pharma Sciences LLC

Lenoir, North Carolina, United States • On-site

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Mid level

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  • Full-time
  • professional certificate
  • Posted 14d ago
  • ~40 hrs/week

Responsibilities

Support attorneys in the Quality Assurance department by managing contracts, vendor qualifications, and audit reports. Ensure company compliance with FDA guidelines and pharmaceutical industry standards while maintaining regulatory dockets.

Requirements

Requires at least 3 years of paralegal experience, preferably in a compliance-driven industry. A paralegal certificate or related degree from an accredited institution is required.

Full job description

Position Summary

Exela Pharma Sciences is seeking a highly motivated, detail-oriented and assertive individual to join our fast-growing company in this non-traditional, yet highly fulfilling career track. The ideal candidate will support our attorneys in our Quality Assurance department in a variety of functions related to the pharmaceutical industry, including regulatory compliance, manufacturing operations, contract management, while driving efficiencies in executing daily tasks with a sense of urgency.  

Job Responsibilities 

  • Contract Management: Assist in drafting, reviewing, and maintaining Vendor Qualification documents, Quality Agreements, and Audit Reports. Ensure all agreements are complete, unexpired, and compliant with company policies and FDA regulations. 
  • Regulatory Compliance: Support the legal team in ensuring that the company complies with all applicable pharmaceutical regulations, including FDA guidelines, drug safety laws, and pharmaceutical industry standards.
  • Document Management: Maintain and organize FDA compliance documents and records, ensuring proper filing and compliance with retention policies.
  • Prepare and Maintain Regulatory Compliance Activities Docket:  Drawing on your paralegal experience, this activity involves preparing specific task lists and execution timelines and enforcing adherence to those timelines.
  • Task Execution: Execute tasks in a disciplined and time-conscious manner to bring efficiency in daily tasks. 

Experience Requirements   

  • At least 3 years of experience as a paralegal. No experience in the pharma industry is needed. 
  • Experience in a compliance-driven industry (banking, pharma, automotive, etc) is a plus.
  • Strong organizational and time-management skills, attention to detail and accuracy are must. 
  • Excellent written and verbal communication with assertiveness
  • Ability to work independently and as part of a team
  • Proficient in Microsoft Office Suite and legal document management systems
  • Ability to handle highly confidential information with discretion and professionalism. A proactive attitude with a willingness to learn and adapt to a fast-paced environment.

Education Requirements 

  • Paralegal certificate or a related degree from an accredited institution.

EOE, including disability/vets

Related keywords

ParalegalPharmaceutical IndustryFDA GuidelinesQuality AssuranceRegulatory ComplianceContract ManagementVendor QualificationQuality AgreementsAudit ReportsDrug Safety LawsDocument RetentionCompliance Docket

About Exela Pharma Sciences LLC

LinkedInVisit site

Enhancing Lives ...With Passion

Industry
Pharmaceutical Manufacturing
Company size
501-1,000 employees
Founded
2005
Headquarters
Lenoir, NC
LinkedIn followers
5,203

Exela Pharma Sciences, a fast-growing specialty pharmaceutical company, focuses on developing, manufacturing and marketing generic and proprietary injectable and sterile ophthalmic products that keep the healthcare provider and patient in mind. Our goal is to deliver high quality, affordable products that make a difference in people’s lives, and also meet the needs of the healthcare providers that treat them. Exela targets the development and manufacturing of generic and proprietary injectable and sterile ophthalmic products with high barriers to market entry, via an Abbreviated New Drug Approval or 505(b)(2) regulatory pathway. We develop products that enhance the patient or provider experience such as easing the burden of administration, providing an improved safety profile, faster drug preparation, or reduce drug waste. In other words, we strive to improve patient outcomes while reducing overall health care costs.

Offices: 1245 Blowing Rock Blvd, Lenoir, NC 28645, US

Health CareWellnessMedicalManufacturingPharmaceutical
View all jobs at Exela Pharma Sciences LLC

About Exela Pharma Sciences LLC

LinkedInVisit site

Enhancing Lives ...With Passion

Industry
Pharmaceutical Manufacturing
Company size
501-1,000 employees
Founded
2005
Headquarters
Lenoir, NC
LinkedIn followers
5,203

Exela Pharma Sciences, a fast-growing specialty pharmaceutical company, focuses on developing, manufacturing and marketing generic and proprietary injectable and sterile ophthalmic products that keep the healthcare provider and patient in mind. Our goal is to deliver high quality, affordable products that make a difference in people’s lives, and also meet the needs of the healthcare providers that treat them. Exela targets the development and manufacturing of generic and proprietary injectable and sterile ophthalmic products with high barriers to market entry, via an Abbreviated New Drug Approval or 505(b)(2) regulatory pathway. We develop products that enhance the patient or provider experience such as easing the burden of administration, providing an improved safety profile, faster drug preparation, or reduce drug waste. In other words, we strive to improve patient outcomes while reducing overall health care costs.

Offices: 1245 Blowing Rock Blvd, Lenoir, NC 28645, US

Health CareWellnessMedicalManufacturingPharmaceutical
View all jobs at Exela Pharma Sciences LLC

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