Job Information
Alkermes, Inc. Sr QA Associate I - 13146 in Wilmington, Ohio
POSITION SUMMARY
The Quality Assurance Senior Associate -- OSD Support is responsible for supporting daily operations and monitoring compliance of the Oral Solid Dose (OSD) Manufacturing Area.
MAJOR RESPONSIBILITIES
Major Responsibilites Estimate percentage of time spent on each responsibility Act as QA OSD Support representative on special committees and teams. Lead specific aspects of a project and guide solutions for difficult problems identifying best solutions based on project requirements. Actively participate and contribute to the QA mission and objectives. Deliver key business messages to superiors and/or peers in a timely manner. Develop metrics and other tools to measure QA OSD Support and/or systems. Understand departmental KPIs and their impact on site targets. 30% Interact with OSD Manufacturing personnel to ensure cGMP compliance and provide general guidance and support. In these interactions, act as an ambassador of quality and compliance, driving quality culture by actively mentoring or coaching within the QA and manufacturing organizations. 20% Review and approve SOPs, master production records, training plans, work orders, and controlled forms. Provide input for, review, and approval of technical protocols and reports, equipment, process, and cleaning documents authored by the validation. 20% Review, approve, and oversee the change control process for minor change controls generated by the OSD Manufacturing Area, including amendments and extensions. 15% Act as the QA Contact and QA Approver for OSD Manufacturing investigations, incidents, minor deviations, environmental excursions, and executed CAPA. Assist in the identification of discrepancies, ensure investigations are thorough, drive to root cause, and have appropriate CAPA in place. Able to lead exercises in root causes analysis within areas of support or cross-functionally for complex issues. Act as an internal auditor, leading audit when necessary. 15%
QUALIFICATIONS
Capable of identifying solutions and following through to implementation. Has the capacity to monitor the effectiveness of system and process changes and continuously improve.
Excellent communication and documentation skills. Demonstrates empathy and active listening and provides opportunities for individuals to talk freely in an open honest discussion setting. Communicates well in team settings. Seeks to understand others with diverse view points and expertise. Builds strong relationships with stakeholders external to QA and takes advantage of these relationships to identify new opportunities.
Experience providing feedback on deficiencies to improve systems, procedures, and training. Demonstrates diplomacy and tact to diffuse tense situations and presents facts to support decision/point of view.
Possesses the skills necessary to provide effective training/mentorship.
Familiarization with oral solid dose manufacturing qualification and quality.
Possesses a good understanding of current quality control and quality assurance GMP regulations.
Continues to develop knowledge in OSD and expands breadth of knowledge to include areas outside of direct function.
Possesses the drive to achieve results and proactively seeks solutions when circumstances and goals are challenging, taking action to overcome likely obstacles.
Demonstrates 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.
Appreciates the organizational vision/ site strategy and understands how
