QA Analytical Specialist: GMP Lab Quality & Investigations

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

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