Description
This position is on-site, responsible for quality oversight of a GMP manufacturing facility, including manufacturing processes, controlled areas, critical utilities (e.g. WFI, Steam, Automation, equipment, HVAC, etc.), and batch record review.
Incumbent provides technical expertise on GMP equipment and Quality Assurance standards and processes to team members. Ensures compliance to clinical and commercial products cGMP regulations during manufacturing and facility operations.

Duties & Responsibilities
Collaborate in evaluation of identified issues, resolution and to ensure compliance with all applicable regulations.
Identifies, classifies and reports deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with cross functional team members to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
Authorized to suspend any operation when the situation warrants and immediately notify Quality Management. Provides guidance and control directives regarding remediation activities required to continue production. Is required to escalate critical issues within area assigned to senior management team based on severity of the issue.
Performs independent technical review of documentation during and post-execution of cGMP activities, including batch records and Work Orders. Ensures all specifications are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.
Provides continuous improvement ideas in the assigned area tand drive change through the use of Quality Systems. May attend project team meetings to provide QA guidance and oversight to such improvements.
Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of BIFIs Quality Systems.


Requirements
Requires a Bachelors Degree preferably in sciences plus minimum of 3 years of experience working in the Quality related aspects of a life sciences or closely related industry.
In lieu of a Bachelor's Degree, a High School Diploma plus 7 years of experience working in the Quality related aspects of a life sciences or closely related industry will be considered.
Related work experience executing on or overseeing equipment in a cGMP environment.
Must be able to demonstrate understanding of biopharmaceutical manufacturing, technical equipment, facility, Quality Assurance/Systems and the interface between equipment and the associated automation.
Has a technical understanding of manufacturing equipment performance and can identify areas of improvement.
Must possess excellent verbal and written communication skills; good interpersonal skills.
Strong independent judgment and decision making abilities required.
Demonstrated problem-detection and problem-resolution skills required.
Strong conflict resolution and negotiation skills required.
Ability to communicate in an open, customer-focused manner.
Ability to influence in a team environment and collaborate with peers.
Ability to interpret and relate Quality standards for implementation and review to functional areas.
Ability to work effectively on problems of diverse scope, with analysis/evaluation of data.
Attention to detail, safety, quality and customer requirements.