Quality Assurance Specialist

Avispa Technology•Philadelphia, PA

32d•$35 - $40•Onsite

About The Position

A leading biotechnology company is seeking a Quality Assurance Specialist. T he successful candidate will provide quality, technical support, and oversight during manufacturing activities.

Requirements

3-5 years in a regulated manufacturing environment with exposure to the Quality and Manufacturing field.
Bachelor’s Degree in a scientific discipline.
Knowledge of Quality Systems such as Change Control, Investigations, and CAPA.
Ability to communicate effectively witha wide range of personnel
Technical writing skills related to investigation reports.
General working knowledge of relevant governmental regulations, cGMP, and guidelines.
Ability to participate in cross-functional teams in root cause analysis and solution identification.
Ability to work collaboratively in the process of conflict resolution to resolve deviations, effectively CAPAs, and identify requirements to implement changes in a controlled GMP environment.

Nice To Haves

Pharma background preferred.

Responsibilities

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 before 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.