Temp-QA Associate

Alkermes; Cincinnati (OH); On-site; USD 34,000 - 55,000; Full time

Job summary

Alkermes is seeking a temporary Quality Assurance support role in Cincinnati, OH to assist manufacturing operations and quality systems. Responsibilities include issuing GxP docs, maintaining the Document Management System, and developing SOPs while ensuring compliance with GMP guidelines.

The candidate should have 0–2 years of QA experience in the pharmaceutical industry, strong communication skills, and the ability to work in a fast-paced environment with a team.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 0–2 years’ QA experience in pharmaceutical industry.
• Knowledge of US and European GMP regulations and guidance.

Responsibilities

• Issue GxP documentation.
• Support Document Management System.
• Manage document lifecycle (scanning, verification, retention, destruction).
• Develop SOPs and other quality documents.
• Evaluate executed documentation (logbooks, forms).
• Support area initiatives and projects.

Skills

Quality Assurance experience

GMP knowledge

Written and verbal communication

Quality systems support

Documentation management

Education

Bachelor’s degree in a scientific discipline

Job description

Job Description

This is a temporary position.

This role is responsible for supporting the daily activities related to manufacturing operations and quality systems.

Responsibilities

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

QUALIFICATIONS

• 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.

About Us

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

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.