Qa Specialist

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: QA Specialist
Location: Swiftwater, PA
Duration: Long Term

Job Overview

We are looking for a QA Specialist with 3 5 years of experience in pharmaceutical or biotech manufacturing, with strong knowledge of GMP, deviations, quality systems, and continuous improvement.

Key Responsibilities

• Manage deviations and support quality investigations.
• Maintain and support quality systems.
• Support GMP manufacturing and continuous improvement activities.
• Work with digital manufacturing systems such as eBR, MES, or Opstrakker.
• Coordinate with Quality and Manufacturing teams.
• Review manufacturing performance metrics, including OEE, to identify process and equipment improvement opportunities.
• Support quality activities related to formulation, filling, lyophilization, and inspection processes.

Required Qualifications

• Bachelor's degree with 3 5 years of relevant experience.
• Experience in GMP pharmaceutical or biotech manufacturing.
• Strong knowledge of deviations and quality systems.
• Experience with eBR, Opstrakker, MES, or similar systems.
• Experience with Veeva or Qualipso is acceptable.
• Knowledge of OEE and manufacturing performance metrics.
• Experience in formulation, filling, lyophilization, or inspection is preferred.
• Good communication and problem-solving skills.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.