Browse by job sector

QA Specialist

  1. North America, United States
Ohio
  1. Contract
Competitive
  1. CAPEX Projects
36199
Apply to this job Save job
QA Specialist - Ohio - 12 months contract with potential extensions 

This is a fantastic opportunity for a QA Specialist  to join our major, global pharmaceutical client on their latest new-build project based in Ohio, this is a large-scale greenfield capital project and investing more than $1bn.

Responsibilities:
  • Provide leadership and guidance on all quality-related aspects of laboratory operations.
  • Ensure compliance with GMP, FDA, and other regulatory requirements in lab systems, processes, and documentation.
  • Oversee C&Q, verification, and validation activities, ensuring adherence to internal quality policies and regulatory expectations.
  • Serve as a quality representative during audits and inspections, addressing findings and implementing corrective actions.
  • Lead quality oversight for the commissioning and qualification of lab equipment and systems, including automation and computer systems.
  • Review and approve validation documentation such as URS, FRS, IQ, OQ, and PQ protocols to ensure compliance.
  • Support validation efforts by providing technical expertise on data integrity, electronic records, and compliance with 21 CFR Part 11 and other applicable regulations.
  • Identify potential quality risks and work proactively to implement mitigation strategies.
  • Support CAPA (Corrective and Preventive Actions) processes and investigations related to laboratory operations.
  • Collaborate with stakeholders to drive continuous improvement initiatives while maintaining regulatory compliance.
  • Work closely with cross-functional teams, including engineering, IT, and laboratory staff, to align on quality requirements and expectations.
  • Provide training and mentorship to lab personnel on quality and compliance best practices.
  • Act as a point of contact for quality-related queries and ensure timely resolution of compliance issues.
Skills and Experience:
  • Extensive experience in pharmaceutical manufacturing quality assurance, with experience in laboratory environments preferred.
  • Strong working knowledge of GMP, C&Q, verification, validation, and regulatory compliance requirements.
  • Experience with automation and computer systems validation (CSV) within a GMP environment.
  • Excellent problem-solving skills and ability to work in a dynamic, fast-paced environment.
  • Experience with laboratory automation systems and computerized systems compliance.
  • Familiarity with quality management systems (QMS) such as TrackWise or similar platforms.
  • Strong understanding of data integrity guidelines and electronic documentation management.
  • Ability to lead quality initiatives and process improvement projects.
If this role is of interest, please apply now!
 #LI-AN1


Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Project Controls Professional

Salary

Competitive

Location

Illinois

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

United States

Description

Project Controls Professional - Illinois, United States - 12 Months Contract  This is a fantastic opportunity for a Project Controls Professional to join our major, global pharmaceutical client

Reference

36341

Expiry Date

01/01/0001

Kristen Scott

Author

Kristen Scott
Kristen Scott

Author

Kristen Scott
Read more
Read more
Site Safety Lead

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

United States

Description

Site Safety Lead - North Carolina - 12 Months Contract Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of  Site Safety Lead. A leader in the industry,

Reference

36358

Expiry Date

01/01/0001

Davis Atkinson

Author

Davis Atkinson
Davis Atkinson

Author

Davis Atkinson
Read more
Read more
Automation Engineer

Salary

Competitive

Location

Ireland

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

East

Description

Automation Engineer - Ireland - 11 Months Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our

Reference

36350

Expiry Date

01/01/0001

Dawn Hosier

Author

Dawn Hosier
Dawn Hosier

Author

Dawn Hosier
Read more
Read more

Insights

North Carolina

Living and working in North Carolina
Read more

03/26/2024

Living and Working in Michigan

Living and Working in Michigan
Read more

10/25/2023

Living and Working in Chicago

Living and Working in Chicago

Read more

08/18/2023

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV