Quality Assurance Associate
2 weeks ago
Responsibilities:
Duties:
Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real time observation of activities, issue identification/ resolution including proper and timely documentation. Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be proactively shared across QA and the business including the on-going training of junior team members. Identifies, classifies and reports deviations, as appropriate and typically works on more complex Minor and/or Major deviations. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations. Provides guidance directives regarding remediation activities required to continue production. Oversees execution of remediation/CAPA activities required to continue production or move a process along. Is required to resolve critical issues within area assigned and may escalate to senior management team based on severity of the issue. Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls. This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business. Performs independent technical review of documentation including Batch Production Records during and post-execution of cGMP activities. Has authority to sign off/qualify/train junior staff on QA Operation responsibilities. Ensures all specifications are met and that requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings to appropriate departments. Works closely with others to recognize opportunities for improvement and drive change through the use of BIFI' Quality Systems.
Skills:
Capability to establish good relationships with others who have different values, cultural styles and perspectives. Setting high and ambitious goals and standards for oneself and others, continuously raises the bar. Five (5) to seven (7) years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas. Strong independent judgment and decision making abilities required. Project management experience Strong knowledge of relevant regulatory guidances. Demonstrated problem-detection and problem-resolution skills required. Strong conflict resolution and negotiation skills required. Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects. Must possess excellent verbal and written communication skills; good interpersonal skills.
Education:
Bachelors degree in Life Sciences or Engineering
Education: High School
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