Collabera · 4 hours ago
Specialist Quality Assurance
Holly Springs, NC
Contract
Onsite
Mid LevelCollabera is a company that provides quality support and oversight for the commissioning, qualification, and process qualification of facilities and equipment. The Quality Assurance professional will collaborate cross-functionally to ensure project timelines and milestones are achieved while performing quality reviews and ensuring compliance with regulations.
ConsultingInformation ServicesInformation Technology
Hiring Manager
Pramodita Pradhan
Responsibilities
Support Quality oversight for Commissioning & Qualification (C&Q) and validation activities at the site, including facilities/utilities, equipment/systems, computerized systems, process, and validation maintenance
Perform quality reviews of documents to support facility commissioning and qualification in line with project timelines, including: - Commissioning / Qualification Protocols
Performance Qualification Protocols (PQ)
Review and approval of protocol discrepancies
Review of final reports and summary documents
Provide quality support during the execution of commissioning and qualification testing, reviewing and approving changes and discrepancies as required
Ensure all activities and related documentation for facilities, equipment, materials, and processes comply with applicable regulations and company requirements related to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Ensure documents comply with company procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices (GDP)
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
Qualification
Required
Quality Assurance (QA) professional will provide quality support and oversight for the commissioning, qualification, and process qualification of facilities, utilities, computer systems, and equipment
Support Quality oversight for Commissioning & Qualification (C&Q) and validation activities at the site, including facilities/utilities, equipment/systems, computerized systems, process, and validation maintenance
Perform quality reviews of documents to support facility commissioning and qualification in line with project timelines, including: Commissioning / Qualification Protocols
Performance Qualification Protocols (PQ)
Review and approval of protocol discrepancies
Review of final reports and summary documents
Provide quality support during the execution of commissioning and qualification testing, reviewing and approving changes and discrepancies as required
Ensure all activities and related documentation for facilities, equipment, materials, and processes comply with applicable regulations and company requirements related to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Ensure documents comply with company procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices (GDP)
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
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
Founded in 1991
10001+ employees
H1B Sponsorship
Collabera has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Leadership Team
Lalit Sharma
CFO
Michael H. Abraham
Chief Financial Officer
Recent News
2024-04-09
2023-01-20
2022-04-19
Company data provided by crunchbase