QA Analytical Specialist

Spectraforce Technologies, Inc.; New Philadelphia (PA); On-site; USD 75,000 - 100,000; Full time

Job summary

Spectraforce Technologies, Inc. in Philadelphia is seeking a QA Analytical Specialist to review QC testing records and investigations to ensure GMP compliance and proper product disposition.

You will work with QA, QC and Manufacturing to identify improvement opportunities and support regulatory inspections. Responsibilities include approving analytical testing across materials and products, reviewing internal/external results, conducting investigations, CAPAs, change controls, and preparing CoAs

Qualifications

• BS/BA in Biology, Chemistry, Engineering, or related science is required.
• 2–5 years in the pharmaceutical/biotechnology industry.
• GMP environment experience.
• Knowledge of quality systems (change control, investigations, CAPA).
• Ability to communicate and document technical reports.
• Knowledge of GMP, USP, ICH and FDA guidelines.

Responsibilities

• Ensure analytical testing is conducted per approved methods and filings.
• Review internal and external analytical and microbiology testing for compliance.
• Provide QA expertise for analytical testing issues from QC.
• Troubleshoot lab investigations and deviations during manufacture or testing.
• Ensure lab investigations, deviations, CAPAs, and change controls are closed before release.
• Author, revise, and approve SOPs as required.
• Inspect and release materials for production against MSS.
• Review vendor certificates for completeness and compliance.
• Evaluate results against specifications to determine release or disposition.
• Prepare CoA for clinical and/or commercial materials.
• Review lot test results against trends.
• Assist in audits of QC groups and CTLs.
• Support regulatory inspections.

Skills

GMP compliance

QA/QC collaboration

Analytical testing

OOS investigations

CAPA & change control

SOP authoring

Documentation review

Regulatory inspections

Education

BS/BA in Biology, Chemistry, Engineering

Job description

Position Title: QA Analytical Specialist
Work Location: 3737 Market Street, Suite 1300, Philadelphia, Pennsylvania
Assignment Duration: 12 months

Position Summary:

• 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 our organization.

Key Responsibilities:

• 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 MSS.
• 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.

Qualification & Experience:

• 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.