Quality Assurance Specialist

Avispa Technology•Philadelphia, PA

1d•Onsite

About The Position

A leading biotech company is looking for a Quality Assurance Specialist. The candidate will provide quality, technical support, and oversight during manufacturing activities.

Requirements

3-5+ years in a regulated manufacturing environment with exposure to Quality and Manufacturing field.
Bachelor’s Degree in scientific discipline.
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.
With guidance from senior dept members ability to create and organize cGMP system procedures based on regulatory / compliance regulations.
Ability to work collaboratively in the process of conflict resolution for resolve deviations, effective CAPA’s, and identifying requirements to implement changes in a controlled GMP environment.

Responsibilities

Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition at Spark.
Open deviations as appropriate based upon Spark 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.
Provide support for Quality Risk Management governance, including maintenance of documentation, risk register, CAPA plans, etc.
Prepare certificate of compliance (CoC) and/or certificate of analysis (CoA) for products for clinical and/or commercial materials.