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Quality Assurance Operations Specialist

QA Laboratory Operations is responsible for managing Quality Assurance aspects related to Quality laboratory operations. This includes quality oversight on laboratory-based initiatives such as technical transfers, equipment and method changes, investigations, and periodic trending and reporting. This role will liaise with internal partners (e.g. Quality control, analytical technology functions) in support of daily operations and conflict resolution, and act as a QA representative on associated projects related to Quality laboratory operations.Responsibilities:1. Provides quality support through quality review and approval of investigations or change controls.2. Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of laboratory operations including, incoming, in-process, release, and stability testing.3. Reviews and approves laboratory periodic trending and performance reports4. Reviews and approves LIMS and LES changes5. Liaises with internal partners (e.g. Quality control, analytical technology functions) in support of daily operations and conflict resolution6. Review and approval validation/qualification/verification protocols and reports associated with new product or material entry.7. Ensures clear communication on issues and timely escalation as applicable8. Helps maintain site practices and procedures related to laboratory instrument qualification, usage, and method execution and trending, ensuring compliance with regulatory expectations9. Drives opportunities for continuous improvement.10. Conducts quarterly walkthroughs of Quality Control laboratories11. Represent QA in cross functional meetings12. Provide training on QA owned proceduresQualifications:Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred. A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on quality operations desired Knowledge of biotech bulk and finished product manufacturing and associated analytical testing is highly desirable. Knowledge of US and EU cGMP regulations and guidance. Knowledge of electronic systems including any of the following: LIMS, TrackWise, LES, Empower, DCA, Maximo desirable Past experience where one was required to work in a team based environment with a diverse group of people. Excellent writing and oral communication skills are required Demonstrated attention to detail, and the ability to perform well in a team-based environment are required. Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, and apply knowledge of subject matter expertiseKnowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred. A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on quality operations desired Knowledge of biotech bulk and finished product manufacturing and associated analytical testing is highly desirable. Knowledge of US and EU cGMP regulations and guidance. Knowledge of electronic systems including any of the following: LIMS, TrackWise, LES, Empower, DCA, Maximo desirable Past experience where one was required to work in a team based environment with a diverse group of people. Excellent writing and oral communication skills are required Demonstrated attention to detail, and the ability to perform well in a team-based environment are required. Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, and apply knowledge of subject matter expertiseExcellent computer skills and proficiency with MS Office is required.Contacts are primarily with Quality Assurance and QC operations, as well as Clinical Manufacturing.

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