Duties in this role of Quality Specialist the individual will be responsible for working with CMO's review and approves manufacturing batch records, manage and approve deviations, investigations, and corrective actions related to product release. This position will perform a variety of tasks with minimal supervision and in accordance with current GMP's.
Responsibilities include:
Review and release production batch records.
Manage product complaints using PTC
Review and manage change controls. Providing Quality Review and approval of deviations related to Manufacturing Equipment, Facility and production.
Participating on team to investigate deviations to determine appropriate root cause and CAPAs and be responsible for CAPA resolution
Create change controls, Deviations and CAPA s in the Phenix system
Report metrics and create monthly and quarterly reports.
Review and approve validation protocols associated with manufacturing and Quality activities.
Develop Sop's as required
Performs in accordance with SOP's, safety and GMP guidelines to support release of finished pharmaceutical product
Maintain and increase scientific, regulatory and compliance expertise and work with existing QA group to develop organizational and technical capabilities.
Be current with various regulatory requirements and procedures.
Some weekend and overtime scheduled work hours are required to support operations.

Skills
5 to 7 years of experience working in a CGMP environment
Experience working in Quality in a GMP environment
Experience working in a Quality role supporting production
Experience with technical writing
Ability to operate in an environment with strict timelines
Experience performing work that consistently requires decision making and the exercise of judgment and discretion in a CGMP environment
Experience demonstrating written and verbal communication skills
Experience demonstrating proficiency with Microsoft Office applications