QC Specialist IV - Instrumentation Support
The position requires the individual to perform routine laboratory equipment calibrations, PM s, and troubleshooting and complete all necessary documentation using cGMP s. The position requires qualifying new equipment and working with vendors as needed according to Alkermes policies. Participates in the preparation of investigations, summaries and reports as needed. Revises and updates standard operating procedures as needed. May perform special projects on instrument problem solving. Expected to adhere to cGMP s in all work practices, proactively assist other team members, and review peer's work as needed.
* Perform routine laboratory equipment calibrations, PM s, and troubleshooting
* Complete all necessary documentation using cGMP s
* Qualify new equipment and work with vendors
* Participate in the preparation of investigations, summaries, and reports
* Revise and update standard operating procedures
* Perform special projects on instrument problem solving
* Adhere to cGMP s in all work practices
* Proactively assist other team members, and review peer's work as needed
* Practical troubleshooting experience of various types of laboratory instrumentation
* Ability to operate and calibrate laboratory equipment
* Ability to follow written procedures and exhibit excellent documentation practices
* Working knowledge of analytical GMP laborartory
* Knowledge with Empower, LIMS, ELN, SDMS etc. is a plus
* Knowledge of Maximo and Veeva a plus
* Ability to work well with equipment vendors and in a team setting
Education and Experience
* Minimum BS degree in Chemistry or related scientific field
* 8 years experience in pharmaceutical quality control
Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. Through our proven scientific, development and manufacturing capabilities, Alkermes is uniquely positioned to be an engine of innovative treatments for major clinical conditions specifically focused on central nervous system (CNS) disorders, such as schizophrenia, depression, addiction and multiple sclerosis.
Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts, as well as research and manufacturing facilities both in Athlone, Ireland and in Wilmington, Ohio. Currently an opportunity for a QC Specialist III-Instrumentaiton Support is available at our Wilmington, Ohio facility. This rapidly expanding facility is within a 1-hour commute from the Cincinnati, Columbus, and Dayton metro areas.
For more information, please visit the 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, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, Alkermes applies our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease.