QA Specialist

In this dynamic, hands-on role, you will lead the maintenance and enhancement of the Quality Management System (QMS) at Flamma’s Malvern, PA site. Reporting to the QA Supervisor, you will ensure compliance with cGMPs, corporate policies, and procedures. Your responsibilities will include overseeing controlled documentation, reviewing and approving change controls, deviations, CAPAs, and batch records, and managing site training. Additionally, you will review documentation for the disposition of GMP components, raw materials, intermediates, and APIs. This role offers significant responsibilities and the opportunity to contribute directly to the success of the QMS and overall product quality.

QA Specialist:
Responsibilities:

• Maintain and improve the site’s Quality Management System.
• Oversee the site’s compliance with cGMPs, corporate policies, and procedures.
• Creation and maintenance of controlled documentation, including SOPs, Analytical Data, COAs, Methods of Analysis, etc.
• Review and approval of change control, deviations, CAPAs, and LIRs.
• Administrator of site training including scheduling, re-training, and training on revised documentation.
• Review and approve documentation for the disposition of GMP components, raw materials, intermediates, and APIs.
• Review and approve master and executed batch records for GMP campaigns.
• Assist in audits.

Qualifications:

• Bachelor’s of Science Degree with 3-5 years of industry experience
• Knowledge of regulatory compliance including 21CFR Part 211
• Strong organizational skills and detail oriented
• Strong technical writing skills
• Ability to work independently to meet tight deadlines.
• Experience working in a synthetic and/or analytical laboratory environment with a focus on small molecule pharmaceuticals highly preferred
• QA experience in contract manufacturing for the small molecule arena of the pharmaceutical industry preferred.
• Experience with OSHA regulations preferred