Quality Assurance Analyst

Position Summary

We are seeking a motivated individual for a Quality Assurance Analyst position in a growing CDMO. This role is responsible for supporting the Pharmaceutical Quality System (PQS) through oversight of GMP materials, manufacturing operations, documentation review, and product disposition activities. The position provides Quality Assurance support for warehouse operations, raw material release, batch record review, and batch disposition while ensuring compliance with current Good Manufacturing Practices (cGMP), company procedures, and applicable regulatory requirements..

Essential Responsibilities

• Perform Quality Assurance review and disposition of incoming raw materials and components to support manufacturing operations.
• Review receiving documentation, supplier documentation, certificates of analysis, and inspection records to support material release.
• Perform GMP oversight of warehouse operations, including material receipt, storage, labeling, inventory control, sampling, dispensing, and distribution activities.
• Conduct routine inspections of warehouse and GMP storage areas to ensure compliance with cGMP requirements and established procedures.
• Review executed batch production records, supporting documentation, deviations, and related quality records for completeness, accuracy, and compliance.
• Perform batch disposition activities and support final product release in accordance with established procedures.
• Support investigations, deviations, CAPAs, change controls, and other quality system activities, as assigned.
• Maintain accurate inventory records and support periodic cycle counts and inventory reconciliation activities.
• Participate in internal audits, client audits, and regulatory inspections as required.
• Support the development, revision, and continuous improvement of quality procedures and documentation.
• Maintain current knowledge of applicable cGMP regulations, regulatory guidance, and industry best practices.
• Collaborate with Manufacturing, Warehouse, Quality Control, Validation, and other cross-functional teams to resolve quality and compliance issues.
• Perform other duties as assigned.

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or another relevant scientific discipline, or an equivalent combination of education and experience.
• Minimum of two (2) years of experience in Quality Assurance, Manufacturing, Quality Control, Warehouse Operations, or another GxP-regulated function within the pharmaceutical, biotechnology, medical device, or CDMO industry.
• Working knowledge of current Good Manufacturing Practices (cGMP) and applicable FDA regulations.
• Experience reviewing GMP documentation, including batch records, raw material documentation, and quality records preferred.
• Experience performing raw material disposition, batch review, and/or product release activities preferred.
• Familiarity with electronic quality and inventory management systems (e.g., NuGenesis, MasterControl, ERP, or similar systems) preferred.
• Strong attention to detail with the ability to identify documentation discrepancies and compliance risks.
• Excellent organizational, analytical, and problem-solving skills.
• Effective written and verbal communication skills with the ability to interact across multiple functional departments.
• Proficiency with Microsoft Office applications, including Word, Excel, and Outlook.
• Ability to manage multiple priorities in a fast-paced GMP manufacturing environment.

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Ability to Commute:

• Bethlehem, PA 18017 (Preferred)

Work Location: In person

Salary : $47,674 - $70,036