ApTask Global Workforce (AGW) is seeking a Specialist Quality Assurance for a 12- month contract position with a client located in Holly Springs, NC. This is an onsite position.
Summary: This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification with a focus on Computer System Validation and Automation support. This individual will work alongside the Digital, Technology and Innovation (DTI) and Automation teams to provide QA oversight of the design and technology of the DTI ecosystem and ongoing Automation support to the Manufacturing floor and expansion projects.
Responsibilities: - Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for the site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV).
- Act as the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight.
- Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solutions.
- Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors.
- Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.
- Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation.
- Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required.
- Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and company requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
- Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies.
- Participate in meetings related to document planning, execution, and issue resolution.
- Escalate any compliance concerns or critical gaps to QA management.
Qualifications: - Doctorate degree OR
- Master's degree and 3 years of experience OR
- Bachelor's degree and 5 years of experience OR
- Associate's degree and 10 years of experience OR
- High school diploma / GED and 12 years of experience
- Only candidates available and ready to work directly as ApTask employees will be considered for this position.
Pay rate range: $34.15 - $37.95 hourly.
If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW)
ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website ;br>
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
Never miss an opportunity! Create an alert based on the job you applied for.