QA Specialist
- North America, United States
- Contract
- CAPEX Projects
This vacancy has now expired
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.
- 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.
#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
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