Gforce Life Sciences Part Time Remote Jobs in Usa

Global Product Quality Specialist

12-month Contract

Remote- EST Hours

Responsibilities:

• Quality Systems Support:
• Work collaboratively with internal and external partners to ensure deviations, investigations, OOS/OOTs, CAPAs and change controls adhere to quality system requirements and current GMP expectations.
• Support of regulatory submissions, annual reports and preparation of annual product quality reviews
• Inspection readiness for Internal and external audits
• Compile metrics for continuous improvement initiatives
• Assist in the writing of Quality Agreements
• Documentation Review:
• Review of API, DP and Packaging batch records
• Review of test methods, component specifications, validation protocols/reports, BOM
• Review of stability protocols and reports, and data in LIMS
• Operational QA Support:
• Work with external CDMOs and laboratories in the review of quality events, change controls, data review, and batch record documentation
• Creates and/or ensures on-time closure of Quality records in TrackWise Digital (batch records, deviations, change controls, investigations, CAPAs and effectiveness checks)
• Uploads and routes documents for approval in the company Electric Documentation Management System (Veeva) and DocuSign
• Project QA Support:
• Represent quality on cross-functional teams and provide support to ensure compliance with GMPs, FDA expectations, product specific requirements, and company standards are consistently met
• Ensure the review and release of clinical and commercial lots meet expected timelines to maintain an uninterrupted product supply

Qualifications:

• BS Degree in scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or equivalent experience in a GMP-regulated environment
• 4 to 7 years of experience working within Pharmaceutical Quality, Engineering, Production or QC/Analytical Development function
• Ability to author and/or provide clear, concise, and technically accurate feedback on GMP documents (SOPs, deviations, CAPAs, investigations, protocols, reports)
• Attention to detail required to perform thorough document review, accurate data verification, and consistent application of right first time principles
• Working knowledge of ICH guidelines (e.g., Q7/Q8/Q9/Q10, Q12) and 21 CFR Parts 210/211 and/or EU GMPs, with the ability to apply these requirements to real-world manufacturing, testing, documentation, and release processes
• Experience with at least two QMS elements (e.g. Deviation, CAPA, Change Control)
• Strong written and verbal communication skills; ability to collaborate with cross-functional teams
• Proficiency with MS 365 (Word, Excel, PowerPoint, SharePoint/Teams).
• Experience with electronic QMS/eDMS (TrackWise, Veeva, LIMS) systems is a plus.