QC Analyst II/III

Job Description

Overview

QC Analyst II must have broad knowledge of all the techniques within the laboratory required for the routine support of the microbiology laboratory operations. In this role the Analyst will be a fully functional member of the team responsible for testing, data entry and occasional review of data for finished product, in-process samples, stability samples, clinical materials and raw material release in a cGMP regulated environment

Responsibilities

• Execution of microbiological tests including but not limited to bioburden, LAL, growth promotion, sterility, particulate profiling and microbial identification of bulk, raw materials, in-process material, components, clinical materials and finished product
• Data entry for testing results following GMP regulations into the electronic data management systems
• Perform laboratory investigations for out of specification and/or out of trend results
• Write change controls and work orders for systems and instrumentation changes
• Creation/Revision of SOP's, and other documents required to support testing and ensure compliance
• Participate in non-routine projects, validations and method development to meet departmental and individual goals
• The employee will be required to participate in an on call schedule for various shift, holiday, or weekend work as needed
• The successful employee will have the ability to function in a microbiological laboratory environment; the employee should have no inhibitions regarding safely handling microorganisms present in the laboratory, aseptic gowning, and no health conditions that would prevent them from doing so

Qualifications

• Bachelor's in science, preferably in Biology / Microbiology / Biotechnology or Biochemistry, required
• QC Analyst II - minimum 2 years experience in pharmaceuticals
• QC Analyst III - minimum 4 years experience in pharmaceuticals
• Experience with documentation revision and investigation writing is preferred
• Critical thinker, ability to identify issues and work quickly to bring resolution
• Capable of managing/coordinating multiple priorities in a dynamic environment, while maintaining a professional demeanor
• Understand common microbiological test instrumentation
• Experience of Thermo Sample Manager LIMS or other applicable LIMS systems
• Ability to work safely; seek out and encourage safe practices
• Ability to focus attention to details and ensure high quality work
• Ability to cope with a rapidly changing work environment
• Self-starter that takes initiative to do work with minimal supervision
• Time management skills, Commitment to teamwork, Commitment to continuous improvement

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About Us

Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com

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, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.