What are the responsibilities and job description for the Manufacturing Associate I-Inspection-2nd Shift position at Alkermes, Inc.?
To inspect the GMP (Good Manufacturing Practices) vials - product and glass vials - for defects. Perform label and packaging activities for finished product.
KEY DUTIES:
- 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 area’s 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
SKILLS/ABILITIES:
- 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.
PERSONAL ATTRIBUTES:
- Good math skills
- Self-motivated
- 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
PHYSICAL REQUIREMENTS
- Prolonged periods of sitting or standing.
- Periods of repetitive motion
- Walking, squatting, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
- Steel-toe shoes, scrubs, and other PPE equipment must be worn based on the job being performed. Employee must be able to pass a vision exam before employment and annually.
Qualifications:
Basic Requirements
- High School diploma or equivalent.
Preferred Requirements
- 0-1 year experience in a sterile pharmaceutical operation preferred.
- Associate degree or higher in a science/technical discipline
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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.
Degree LevelHigh School Diploma / GED