Stark Pharma Solutions Inc
Quality Assurance Specialist
Stark Pharma Solutions Inc, Oklahoma City, Oklahoma, United States
Job Title
Senior Quality Assurance Specialist
Location Boston, MA (Hybrid)
Contract Duration 12+ Months
Experience 5+ Years
Overview We’re looking for two experienced Senior Quality Assurance Specialists to support Quality and Compliance functions for ongoing development programs. This role is central to ensuring GMP compliance and maintaining product quality across the clinical lifecycle. The position requires a solid understanding of pharmaceutical quality systems, GMP principles, and hands‑on experience in batch disposition and quality documentation review.
Key Responsibilities
Batch Record Review & Product Disposition
Review executed batch records, Certificates of Analysis (COAs), in-process control data, and stability results.
Support timely and compliant disposition of drug substance, drug product, and finished goods from both internal and external manufacturing sites.
Support or lead investigations for deviations, Out-of-Specification (OOS), and Out-of-Trend (OOT) events.
Conduct thorough root cause analyses and implement effective CAPAs.
Manage change control processes from assessment through implementation and closure.
Represent Quality Assurance on cross-functional project teams.
Partner with groups including Pharmaceutical Sciences, Regulatory CMC, Supply Chain, and R&D Quality to ensure alignment and compliance.
Identify process gaps and drive initiatives that strengthen the Quality Management System (QMS).
Recommend and implement improvements to documentation practices and quality procedures.
Draft, revise, and maintain GMP documents such as specifications, quality agreements, and standard operating procedures.
Support audit readiness and ensure controlled document compliance across the organization and with contract manufacturers (CMOs).
Qualifications
Bachelor’s degree in a scientific or allied health discipline (or equivalent experience).
Minimum 5 years of Quality Assurance experience in a GMP-regulated pharmaceutical or biotechnology environment.
Proven experience supporting batch disposition, deviation management, and CAPA implementation.
Hands‑on QA experience in analytical testing or manufacturing operations.
Strong preference for candidates with small molecule manufacturing experience; exposure to biologics, devices, or gene therapy is a plus.
Solid understanding of regulatory expectations (FDA, ICH, EMA) and cGMP principles across the product lifecycle.
Demonstrated ability to lead investigations, perform risk assessments, and manage multiple quality systems simultaneously.
Core skills: batch record review, CAPA and deviation management, root cause analysis (RCA), change control, quality system documentation, cross-functional collaboration, continuous improvement.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industry Staffing and Recruiting
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Location Boston, MA (Hybrid)
Contract Duration 12+ Months
Experience 5+ Years
Overview We’re looking for two experienced Senior Quality Assurance Specialists to support Quality and Compliance functions for ongoing development programs. This role is central to ensuring GMP compliance and maintaining product quality across the clinical lifecycle. The position requires a solid understanding of pharmaceutical quality systems, GMP principles, and hands‑on experience in batch disposition and quality documentation review.
Key Responsibilities
Batch Record Review & Product Disposition
Review executed batch records, Certificates of Analysis (COAs), in-process control data, and stability results.
Support timely and compliant disposition of drug substance, drug product, and finished goods from both internal and external manufacturing sites.
Support or lead investigations for deviations, Out-of-Specification (OOS), and Out-of-Trend (OOT) events.
Conduct thorough root cause analyses and implement effective CAPAs.
Manage change control processes from assessment through implementation and closure.
Represent Quality Assurance on cross-functional project teams.
Partner with groups including Pharmaceutical Sciences, Regulatory CMC, Supply Chain, and R&D Quality to ensure alignment and compliance.
Identify process gaps and drive initiatives that strengthen the Quality Management System (QMS).
Recommend and implement improvements to documentation practices and quality procedures.
Draft, revise, and maintain GMP documents such as specifications, quality agreements, and standard operating procedures.
Support audit readiness and ensure controlled document compliance across the organization and with contract manufacturers (CMOs).
Qualifications
Bachelor’s degree in a scientific or allied health discipline (or equivalent experience).
Minimum 5 years of Quality Assurance experience in a GMP-regulated pharmaceutical or biotechnology environment.
Proven experience supporting batch disposition, deviation management, and CAPA implementation.
Hands‑on QA experience in analytical testing or manufacturing operations.
Strong preference for candidates with small molecule manufacturing experience; exposure to biologics, devices, or gene therapy is a plus.
Solid understanding of regulatory expectations (FDA, ICH, EMA) and cGMP principles across the product lifecycle.
Demonstrated ability to lead investigations, perform risk assessments, and manage multiple quality systems simultaneously.
Core skills: batch record review, CAPA and deviation management, root cause analysis (RCA), change control, quality system documentation, cross-functional collaboration, continuous improvement.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industry Staffing and Recruiting
#J-18808-Ljbffr