QA Analytical Specialist

Our client, a world leader in life sciences and biotechnology, is looking for a “QA Analytical Specialist” based in Philadelphia, PA.

Job Duration: Long Term Contract (Possibility of Extension)

Pay Rate: $55/hr on W2

Company Benefits: Medical, Paid Sick leave, 401K

Seeking a QA Analytical Specialist with pharmaceutical/biotechnology experience and strong knowledge of GMP quality systems. The individual will review and approve QC analytical and microbiology testing records, laboratory investigations, deviations and batch records to ensure compliance with regulatory requirements and support product release.

Key Responsibilities:

• Review and approve QC analytical and microbiology testing records for raw materials, drug substances and drug products.
• Review OOS investigations, deviations, CAPAs and change controls.
• Provide QA support and technical guidance for analytical laboratory issues and investigations.
• Review executed batch records and evaluate product/facility deviations.
• Evaluate analytical results against approved specifications and support material/product disposition and release.
• Review vendor Certificates of Analysis (CoAs) and prepare product CoAs.
• Review and update SOPs and other GMP documentation.
• Identify testing trends and irregularities.
• Support internal/external audits and regulatory inspections.

Required Qualifications:

• Bachelor's degree in Biology, Chemistry, Engineering or related field.
• 2–5 years of pharmaceutical/biotechnology industry experience.
• Proven experience working in a GMP-regulated environment.
• Knowledge of QC analytical testing and laboratory operations.
• Experience with quality systems: OOS, deviations, CAPA and change control.
• Familiarity with FDA, USP, EP and ICH guidelines.
• Strong technical writing, investigation documentation and communication skills.

If interested, please send us your updated resume at

hr@dawarconsulting.com/akansha@dawarconsulting.com