Sr QA Associate II - Laboratory Support at Alkermes, Inc. in Wilmington, OH

The Quality Assurance Senior Associate – Laboratory Support is responsible for supporting daily operations and monitoring compliance of the laboratories.

MAJOR RESPONSIBILITIES

Major Responsibilities	Estimate percentage of time spent on each responsibility (Must add to 100%)
Act as QA Lab 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 Lab Support and/or systems. Understand departmental KPIs and their impact on site targets.	30%
Interact with laboratory 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 laboratory organizations.	20%
Review and approve SOPs, analytical protocols, test methods, training plans, work orders, and controlled forms. Provide input for, review, and approve technical protocols and reports, stability protocols and reports, and instrument qualification documents authored by the laboratories.	20%
Review, approve, and oversee the change control process for minor change controls generated by the laboratory, including amendments and extensions.	15%
Act as the QA Contact and QA Approver for laboratory 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.
Familiarity with standard Chemistry and/or Microbiology laboratory techniques such as: water content determination, dissolution, HPLC, GC, infrared spectroscopy, DSC, UV, particle size, bioburden, environmental monitoring, endotoxin, and sterility.
Possesses a good understanding of current quality control and quality assurance GMP regulations.
Continues to develop knowledge in relevant suite of products or analytical techniques 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 team and individual objectives are aligned.
Displays the appropriate amount of energy and concentration to "stay with the job" and displays the versatility to accommodate changes that might be required to the schedule to ensure all work activities are completed as required.
Recognizes and displays many of the hallmarks of a personally productive individual. Invests upfront in an appropriate amount of preparation for the task in hand, can eliminate the time-wasting activities, takes an ordered approach to execution.

Years of Experience

Bachelor's in Chemistry or Biology (or related field) with 5+ years of Pharmaceutical Quality experience and/or cGMP Laboratory experience; or,
Master's in Chemistry or Biology (or related field) with 4+ years of Pharmaceutical Quality experience and/or cGMP Laboratory experience

Working Environment/Physical Demands

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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