Jobs with Alkermes, Inc.
(Found 63 Jobs)
QA Associate I/II
Alkermes, Inc.
This role is responsible for supporting the daily activities related to manufacturing operations and quality systems. Once fully trained, this position is eligible for work from home up to 1 day...
Sep 17, 2024
Wilmington, OH
Validation Engineer I/II
Alkermes, Inc.
Validation Engineer I/II
This position provides technical knowledge and execution for process and cleaning validation to support commercial cGMP manufacturing for both sterile injectables and oral sol...
Sep 17, 2024
Wilmington, OH
Supervisor, Quality Assurance
Alkermes, Inc.
Overview:
This position is responsible for providing supervision to the Quality Assurance On-the-Floor (OTF) team, supporting sterile and oral solid dose manufacturing operations. This position...
Sep 17, 2024
Wilmington, OH
Sr QA Associate I - Laboratory Support
Alkermes, Inc.
The Quality Assurance Senior Associate – Laboratory Support is responsible for supporting daily operations and monitoring compliance of the laboratories.
MAJOR RESPONSIBILITIES
Major Responsibil...
Sep 17, 2024
Wilmington, OH
QC Analyst I
Alkermes, Inc.
GENERAL DESCRIPTION:
The QC Analyst I performs testing of samples submitted to the laboratory in a cGMP compliant manner, as well as according to approved written procedures. The QC Analyst I ma...
Sep 17, 2024
Wilmington, OH
This role is responsible for supporting the daily activities related to manufacturing operations and quality systems. Once fully trained, this position is eligible for work from home up to 1 day per week.
Key Duties:
- Issuance of GxP documentation.
- Document Management System Support.
- Support documentation lifecycle (Document Scanning, Verification, Retention, and Destruction).
- Develop Standard Operating Procedures and other quality related documents.
- Evaluation of executed documentation (logbooks, controlled forms, and other documentation).
- Support area initiatives and projects.
Skills / Abilities:
- Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
- Ability to increase others knowledge of US end European GMP regulations and guidance.
- Strong written and oral communication skills.
- Experience in support of quality systems for drug product manufacturing and quality control operations.
- Working knowledge of US Drug Product GMP requirements and associated guidelines.
Personal Attributes:
- Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
- Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others.
- Good computer skills.
- Good work ethic, dependable, punctual, and flexible.
- Good motivator of personnel.
- Good team player with a can-do attitude.
- Can get things done on the basis of influence.
- Can work in a fast-paced environment with multiple issues open simultaneously.
- Highly organized.
- Attention to detail.
- Identifies opportunities to improve and contributes to problem solving.
Education:
- Requires a Bachelor’s degree in a scientific discipline or equivalent experience.
Experience:
- 0-2 years’ experience in a Quality Assurance role in the pharmaceutical industry.
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