Manufacturing Associate-Vial Inspection (Shift TBD) 8/24/2016
JOB DESCRIPTIONAPPLY Manufacturing Associate (Vial Insepction)
Shift To Be Determined
Alkermes, Inc. is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes has an R&D center and US headquarters in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland, and Wilmington, OH. For more information, please visit Alkermes website at www.alkermes.com .
To inspect the GMP (Good Manufacturing Practices) vials - product and glass vials - for defects. Perform label and packaging activities for finished product.
* Inspect vialed product and empty glass for defects
* Perform daily process activities in compliance with standard operating procedures (SOPs)
* Prepare all process specific and ancillary equipment (i.e. glassware, apparatus) for use in assigned areas
* Assist in writing and implementing areas process documents
* Operate equipment in compliance with SOPs
* Assure compliance with cGMP requirements (current good manufacturing practices)
* Work non-routine hours as required to maintain production schedule
* Perform label and packaging activities for finished product
* Complete and review associated production records and daily trending
* Train new inspectors in accordance with vial inspector certification procedures
* Assist other manufacturing functions (Formulation, Fill, Materials) as required
* Organization and interpersonal Skills (Oral, Written, etc.)
* Good Computer and Database Skills
* Comprehensive training focused on current Good Manufacturing Practices (cGMP) in the pharmaceutical industry.
* Good math skills
* Good visual acuity
* Team Oriented
* Effective organization skills and attention to detail
* Ability to work with minimal supervision
* Ability to work flexible hours
* Ability to work hands-on
* High School Diploma or equivalent
* Experience in GMP manufacturing facility desirable
* Vial or general inspection experience desirable
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.