Specialist Quality Assurance
Aequor Technologies LLC
Holly Springs, NC
Apply
JOB DETAILS
LOCATION
Holly Springs, NC
POSTED
30+ days ago
Fully Onsite
Standard Working Hours (Dayshift)
-this is an on site position so will need to be able to be onsite.
-need to be able to gown in, and/or wear construction gear and steel toe boots.
The QA will provide quality support and oversight of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. They will collaborate cross-functionally to ensure project timelines and milestones are met.
Primary Responsibilities:
" Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance.
" Perform quality review of documents to support facility commissioning and qualification, according to project timelines.
o Commissioning / Qualification Protocols
o Performance Qualification Protocols (PQ)
o Review and Approval of protocol discrepancies
o Review of Final Reports and Summary Documents
" Provide quality 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, and processes comply with applicable regulations and *** requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
o Ensure documents comply with *** s 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.
" In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
About the Company
A