Senior Quality Assurance Associate

4 weeks ago

Wilmington, Ohio, United States Alkermes Full time
Job Description

The Senior Quality Assurance Associate - Laboratory Support is responsible for supporting daily operations and monitoring compliance of the laboratories. Key responsibilities include acting as a QA Lab Support representative on special committees and teams, leading specific aspects of a project, and guiding solutions for difficult problems. The ideal candidate will actively participate and contribute to the QA mission and objectives, deliver key business messages to superiors and/or peers, and develop metrics and other tools to measure QA Lab Support and/or systems. Additionally, the candidate will understand departmental KPIs and their impact on site targets, interact with laboratory personnel to ensure cGMP compliance, and provide general guidance and support. The Senior Quality Assurance Associate - Laboratory Support will also review and approve SOPs, analytical protocols, test methods, training plans, work orders, and controlled forms, and provide input for, review, and approve technical protocols and reports, stability protocols and reports, and instrument qualification documents authored by the laboratories. Furthermore, the candidate will act as the QA Contact and QA Approver for laboratory investigations, incidents, minor deviations, environmental excursions, and executed CAPA, and assist in the identification of discrepancies, ensure investigations are thorough, drive to root cause, and have appropriate CAPA in place. The ideal candidate will possess a Bachelor's in Chemistry or Biology (or related field) with 5+ years of Pharmaceutical Quality experience and/or cGMP Laboratory experience, or a Master's in Chemistry or Biology (or related field) with 4+ years of Pharmaceutical Quality experience and/or cGMP Laboratory experience. The candidate will also have excellent communication and documentation skills, demonstrate empathy and active listening, and provide opportunities for individuals to talk freely in an open honest discussion setting. The ideal candidate will also have experience providing feedback on deficiencies to improve systems, procedures, and training, and demonstrate diplomacy and tact to diffuse tense situations and present facts to support decision/point of view. Additionally, the candidate will possess the skills necessary to provide effective training/mentorship, familiarity with standard Chemistry and/or Microbiology laboratory techniques, and a good understanding of current quality control and quality assurance GMP regulations. The ideal candidate will also continue to develop knowledge in relevant suite of products or analytical techniques and expand breadth of knowledge to include areas outside of direct function, and demonstrate ability to generate and critique high quality/quantity of results from the QA team and present them coherently to an internal and/or external audience. The candidate will also appreciate the organizational vision/site strategy and understand how team and individual objectives are aligned, and display the appropriate amount of energy and concentration to 'stay with the job' and display the versatility to accommodate changes that might be required to the schedule to ensure all work activities are completed as required. The ideal candidate will also recognize and display many of the hallmarks of a personally productive individual, invest upfront in an appropriate amount of preparation for the task in hand, eliminate the time-wasting activities, take an ordered approach to execution, and demonstrate a good understanding of current quality control and quality assurance GMP regulations.

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