Quality Assurance Specialist (Pharmaceuticals)

Dawar Consulting•Philadelphia, PA

About The Position

Our client, a world leader in biotechnology and life sciences, is looking for a "Quality Assurance Specialist” based out of Philadelphia, PA. Job Duration: Long Term Contract (Possibility Of Extension) Pay Rate : $42/hr on W2 Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K Duration: Long term contract (Possibility of further extension)

Requirements

Bachelor’s Degree in scientific discipline
Minimum of 3 -5 years in a regulated manufacturing environment with exposure to Quality and Manufacturing field.
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 working knowledge of relevant governmental regulations, cGMP and guidelines.

Responsibilities

Provide quality, technical support and oversight during manufacturing activities.
Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition.
Open deviations as appropriate based upon Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition.
Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed prior to material/lot release.
Review and evaluate QC testing records and any associated OOS investigations.
Review, write, revise, and approve SOP’s, technical documents, and reports.
Perform inspection and release of materials used for production and review vendor certificates for completeness / compliance against approved specifications and collaborate with Material Management to release incoming materials for production.
Compile and maintain metrics for testing results, quality documentation closure, and disposition and evaluate trending data to identify any irregular trends and notify management as required.
Provide administrative project management support for Quality Management System integration and improvement projects.
Provide support for Quality Risk Management governance, including maintenance of documentation, risk register, CAPA plans, etc.
Support coordination of site Change Control Review Board and change control communications with third party license holder.
Prepare certificate of compliance (CoC) and/or certificate of analysis (CoA) for products for clinical and/or commercial materials.