QA Analytical Specialist

Lancesoft; Philadelphia (Philadelphia County); On-site; USD 90,000 - 130,000; Full time

Job summary

Lancesoft is seeking a QA Analytical Specialist to review QC testing records and OOS investigations, working with QA, QC, and Manufacturing to ensure GMP compliance. The role involves oversight of QC testing and investigations, review of batch records, and approval of analytical results and CoAs for materials destined for clinical or commercial use.

The ideal candidate will have a BS/BA in a related science, 2–5 years in pharma/biotech, GMP experience, and strong technical writing and

Qualifications

• BS/BA required in Biology, Chemistry, Engineering or related science.
• 2-5 years pharma/biotech experience; 1-2+ years analytical experience in a lab operations environment preferred.
• GMP experience required; knowledge of USP/EP/ICH and FDA guidelines.
• Strong communication and technical writing skills for investigation reports.

Responsibilities

• Review and approve QC testing records and OOS investigations.
• Oversee QC testing and investigations; review batch records for product disposition.
• Review CoA and ensure testing compliance across materials and products.
• Contribute to investigations/deviations and CAPAs; assist in audits and regulatory inspections.

Skills

Analytical testing

GMP compliance

Technical writing

Investigations & CAPA

Record review

Quality systems

Communication

Education

BS/BA in Biology/Chemistry/Engineering

Tools

Analytical instruments

Job description

Description:

The QA Analytical Specialist will review and approve QC testing records and any associated OOS investigations while working closely with QA, QC and Manufacturing Functional Management to identify strategies, and objectives for improvement to GMP compliance. The incumbent will oversee QC testing and investigations (both internal and external) and will review executed batch records and evaluate product and facility deviations;support conclusions as they impact product disposition at Spark. Ensure drug substance and drug product analytical testing is conducted according to approved methods and regulatory filings. Review and approve internal and external analytical and microbiology testing in all raw material/starting material, buffer solutions, bulk drug substance and drug product for commercial and/or clinical distribution to ensure compliance with global (US/EU/ROW) GMP requirements. Provide QA technical expertise for analytical testing issues that arise from QC testing. Participate in troubleshooting efforts of laboratory investigations/deviations that arise during the manufacture or testing of drug substance. Assure all Quality lab investigations, deviations, change controls, CAPAs and/or other required documentation related to the lots are completed and closed prior to material/lot release. Author, revise, review and approve Standard Operating Procedures as required/assigned. Perform inspection and release of materials used for production against the Client. Review vendor certificates for completeness / compliance against approved specifications. Evaluate analytical results against approved specifications to determine compliance, release materials for use and/or provide an appropriate disposition for product. Prepare certificate of analysis (CoA) for products for clinical and/or commercial materials. Evaluate lot test results against trending data to identify any irregular trends. Conduct record review of executed batch record for bulk drug substance, drug product and packaged lots. Assist in the audits of internal QC groups and/or CTLs. Supports regulatory inspections.

Education and Experience Requirements

BS /BA in Biology, Chemistry, Engineering, or related science discipline is required. Generally, 2-5 years of experience in the pharmaceutical/biotechnology industry. Generally, 1-2+ years analytical experience within a laboratory operations environment preferred. Must have proven experience working in a GMP environment. Analytical and laboratory equipment experience and knowledge in the areas of analytical testing and/or analytical development. Knowledge of quality systems such as change control, investigations and CAPA. Ability to communicate effectively with wide range of personnel. Technical writing skills related to investigation reports. General knowledge of GMP compliance as well as USP, EP, ICH and FDA guidelines.

Interview Process

Initial virtual screen with RRP - 30 minutes, followed by virtual panel interview - 30 minutes (back-to-back)