QA Specialist
- North America, United States
- Contract
- CAPEX Projects
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 quality assurance oversight for C&Q, verification, and validation activities, ensuring compliance with GMP, FDA, and other regulatory requirements.
- Collaborate with engineering, operations, and IT teams to ensure the implementation of quality standards in automated and computer-controlled systems.
- Ensure all quality activities are conducted following applicable policies, procedures, and regulatory expectations.
- Support regulatory inspections and audits, providing documentation and responses as required.
- Lead and provide oversight for commissioning, qualification, and validation of warehouse equipment and systems.
- Review and approve validation documentation, including URS, FRS, IQ, OQ, and PQ protocols.
- Ensure appropriate risk-based approaches are applied to validation and verification activities.
- Monitor and assess changes to computerized systems and automated processes to ensure continued compliance.
- Identify opportunities for quality improvements and implement corrective and preventive actions (CAPAs).
- Support the development and implementation of quality systems, including change control, deviations, and investigations.
- Provide input into process optimization initiatives to enhance operational efficiency while maintaining compliance.
- Act as a quality advocate, providing guidance to project teams, suppliers, and stakeholders on quality and compliance matters.
- Participate in cross-functional project meetings to ensure quality considerations are integrated into project deliverables.
- Provide training and mentorship to team members on quality expectations and regulatory requirements.
- Bachelor's degree in a scientific field (Engineering, Biology, Chemistry, or related disciplines) or equivalent experience.
- Strong knowledge of pharmaceutical quality systems and GMP regulations, with experience in manufacturing environments.
- Previous experience with C&Q, verification, and validation oversight, particularly in automation and computer systems validation (CSV).
- Ability to work independently while collaborating with cross-functional teams to ensure compliance and quality objectives are met.
- Excellent documentation skills and attention to detail, with experience in writing and reviewing technical reports.
- Willingness to work 3 days per week on-site or 2 weeks on / 2 weeks off schedule.
- Experience with quality oversight in warehouse or logistics operations within pharmaceutical manufacturing.
- Knowledge of industry standards such as GAMP 5, 21 CFR Part 11, Annex 11, and relevant data integrity guidelines.
- Strong problem-solving and critical-thinking skills to address quality challenges proactively.
- Experience with electronic quality management systems (eQMS) and document control systems.
#LI-AN1
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Save as job alert
WE’RE NOT JUST
ABOUT THE WORK
Although That’s Pretty Awesome
We’re about an unmatched company culture and a huge range of benefits you’ll love, both on and off the clock.
Check out all our perks hereSimilar Jobs
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
Author
Kristen ScottAuthor
Kristen ScottSalary
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
Author
Davis AtkinsonAuthor
Davis AtkinsonSalary
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
Author
Dawn HosierAuthor
Dawn HosierInsights
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.
Annabel
I manage this role.